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Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)

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ClinicalTrials.gov Identifier: NCT02452892
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Tal Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Depressive Disorder
Depressive Disorder, Treatment-resistant
Depressive Disorder, Major
Intervention Device: LFMS
Enrollment 122
Recruitment Details 12clinical study sites in the US recruited 122 subjects that were randomized into the study. The date of first subject enrollment was 03 September 2015 and the date of last subject enrolled was 22 July 2016.
Pre-assignment Details Subject screening period was up to 14 days before receiving first study treatment. Subjects were contacted by an independent Massachusetts General Hospital-Clinical Trials Network and Institute (MGH-CTNI) rater to perform the Antidepressant Treatment Response Questionnaire (ATRQ) and SAFER assessments to confirm eligibility.
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes LFMS 120 Min
Hide Arm/Group Description For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2, subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

Week 1: Subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.

Week 2: Subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.

Period Title: Week 1 Initial Randommization
Started [1] 41 40 41 0
Completed 40 40 40 0
Not Completed 1 0 1 0
Reason Not Completed
Adverse Event             1             0             0             0
Lost to Follow-up             0             0             1             0
[1]
Week 1 subjects were randomized 1:1:1 allocation to LFMS Sham, LFMS 20min,or LFMS 60min
Period Title: Week 2 Stratification & Re-Randomization
Started [1] 65 [2] 7 [3] 7 [4] 41 [5]
Non-reponders 38 0 0 41
Responders 27 7 7 0
Completed 63 7 7 39
Not Completed 2 0 0 2
Reason Not Completed
Withdrawal by Subject             0             0             0             2
Lost to Follow-up             2             0             0             0
[1]
Subjects stratified by response & re-randomized to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min
[2]
Week 1 Participants that started LFMS sham (27), LFMS 20min (19), and LFMS 60min (19)
[3]
Week 1 Participants that Started LFMS Sham (0), LFMS 20min (7), and LFMS 60min(0).
[4]
Week 1 Participants that Started LFMS Sham (0),LFMS 20min (0), LFMS 60min (7)
[5]
Week 1 Participants that Started LFMS Sham (13), LFMS 20min (14), and LFMS 60 min (14).
Period Title: Follow-up
Started 63 7 7 39
Completed 62 7 7 38
Not Completed 1 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Subject left town on Day 42             1             0             0             0
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes LFMS 120 Min Total
Hide Arm/Group Description

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Total of all reporting groups
Overall Number of Baseline Participants 41 40 41 0 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 0 participants 122 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
37
  90.2%
35
  87.5%
37
  90.2%
0
109
  89.3%
>=65 years
4
   9.8%
5
  12.5%
4
   9.8%
0
13
  10.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 0 participants 122 participants
Female
23
  56.1%
23
  57.5%
26
  63.4%
0
72
  59.0%
Male
18
  43.9%
17
  42.5%
15
  36.6%
0
50
  41.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 0 participants 122 participants
White
31
  75.6%
28
  70.0%
27
  65.9%
0
86
  70.5%
Black or African American
9
  22.0%
9
  22.5%
11
  26.8%
0
29
  23.8%
Asian
1
   2.4%
3
   7.5%
2
   4.9%
0
6
   4.9%
Other
0
   0.0%
0
   0.0%
1
   2.4%
0
1
   0.8%
[1]
Measure Description: White, Black or African American, Asian
1.Primary Outcome
Title Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.
Hide Description

Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline".

Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more.

Time Frame Week 1 Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the All Randomized set who completed at least one treatment session and had at least one post baseline primary efficacy assessment.
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 41 40 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.0
(-5.18 to -2.91)
-4.2
(-5.34 to -3.04)
-4.9
(-6.03 to -3.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 60 Minutes
Comments Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS & sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.
Type of Statistical Test Superiority
Comments To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.
Statistical Test of Hypothesis P-Value 0.307
Comments

P-value displayed for 60min.

Mixed Model Repeated Measures (MMRM) model.

Method Mixed Models Analysis
Comments Week 1 baseline HAM-D6 total score, treatment,visit treatment*visit age, & gender included in model. Visit was the repeated measure within subjects.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 20 Minutes
Comments Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS & sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.
Type of Statistical Test Superiority
Comments To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.
Statistical Test of Hypothesis P-Value 0.859
Comments P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.
Method Mixed Models Analysis
Comments Week 1 baseline HAM-D6 total score, treatment,visit treatment*visit age, & gender included in model. Visit was the repeated measure within subjects.
2.Secondary Outcome
Title Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS
Hide Description

Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4".

To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11.

Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more.

Time Frame Day 11 (Week 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Only non-responders at end of Day 4 comprise this Wk 2 analysis . (Non-responders were defined as those who didn't reach a decrease in 6-item Hamilton Rating Scale for Depression (HAM-D6) total score of 50% compared to baseline Day 1, Week 1). 41 subjects entered Week 2: 1 subject withdrew consent on Day 8 and was not part of the Full Analysis Set.
Arm/Group Title LFMS Sham LFMS 120 Min
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 38 40
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.6
(-3.60 to -1.68)
-2.6
(-3.56 to -1.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 120 Min
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.966
Comments P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.
Method Mixed Models Analysis
Comments Week 2 baseline HAM-D6 total score, treatment, visit, treatment*visit, age, & gender included in model. Visit was the repeated measure within subject.
3.Secondary Outcome
Title Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score
Hide Description To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were HAM-D6 Day 4 responders, defined as those subjects who achieved a 50% or greater decrease in their HAM-D6 total score compared to Baseline ( Day1, Wk 1).
Arm/Group Title LFMS 20 Minutes LFMS 60 Minutes LFMS Sham
Hide Arm/Group Description:

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 13 14 14
Measure Type: Number
Unit of Measure: percentage of LFMS responders
53.8 57.1 78.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS 60 Minutes, LFMS Sham
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.
Statistical Test of Hypothesis P-Value 0.294
Comments For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age & gender as covariates.
Method Regression, Logistic
Comments Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS 20 Minutes, LFMS Sham
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.
Statistical Test of Hypothesis P-Value 0.232
Comments For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age & gender as covariates.
Method Regression, Logistic
Comments Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response
4.Post-Hoc Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)
Hide Description

The MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in subjects with Major Depressive Disorder (MDD). Individual items are rated on a scale of 0 to 6 in which a score of 6 represents the most severe symptoms for each item assessed. The total score ranges from 0 to 60.

Remission of depression based on the MADRS is defined as a subject with a MADRS total score of ≤11 at endpoint. A responder on the MADRS is defined as a 50% or greater reduction from baseline in total MADRS score

Time Frame Day 4 Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, Week1
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 41 40 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-7.58
(-9.8 to -5.4)
-8.09
(-10.3 to -5.8)
-10.32
(-12.6 to -8.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 60 Minutes
Comments Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0932
Comments P-value is not adjusted for multiple comparisons.
Method ANCOVA
Comments P-value was estimated using ANCOVA model with treatment, age, & gender as factors and baseline negative MADRS score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 20 Minutes
Comments Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7509
Comments The p-value is not adjusted for multiple comparisons.
Method ANCOVA
Comments P-value was estimated using ANCOVA model with treatment, age, & gender as factors and baseline negative MADRS score as a covariate.
5.Post-Hoc Outcome
Title Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score
Hide Description The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Used as a psychometric scale, the PANAS can show relationships between positive and negative affect with personality stats and traits. Descriptors are used to define their meanings. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).To calculate the positive affect score, added scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, which higher scores representing higher levels of positive affect, or the extent to which the individual feels enthusiastic, active and alert.
Time Frame Day 4 Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (Week 1).
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 41 40 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.67
(-0.29 to 3.62)
3.62
(1.63 to 5.62)
3.24
(1.23 to 5.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 60 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.
Statistical Test of Hypothesis P-Value 0.2672
Comments P-value not adjusted for multiple comparisons.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment,age,& gender as factors & baseline positive PANAS score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 20 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.
Statistical Test of Hypothesis P-Value 0.1660
Comments P-value not adjusted for multiple comparisons.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment,age,& gender as factors & baseline positive PANAS score as a covariate.
6.Post-Hoc Outcome
Title Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4
Hide Description

The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.

This analysis outcome treated Item #2 as random missing data.

Time Frame Day 4, Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Week 1.Item #2 was incorrectly listed as “Disinterested” instead of “Distressed”.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 41 40 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.27
(-4.20 to -0.34)
-3.57
(-5.55 to -1.59)
-5.32
(-7.31 to -3.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 60 Minutes
Comments

Due to item #2 error, analyses were done in the following manner to check robustness:

  • All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).
  • The 72 data points were removed & the negative score for affected subjects & visits were not calculated.
  • The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average.
Type of Statistical Test Superiority
Comments Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.
Statistical Test of Hypothesis P-Value 0.0307
Comments P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 20 Minutes
Comments

Due to item #2 error, analyses were done in the following manner to check robustness:

All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).

The 72 data points were removed & the negative score for affected subjects & visits were not calculated.

The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average.

Type of Statistical Test Superiority
Comments Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.
Statistical Test of Hypothesis P-Value 0.3537
Comments

P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.

.

Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.
7.Post-Hoc Outcome
Title Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4
Hide Description

The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.

This analysis outcome treated Incorrect Item #2 where Item #2 data was removed.

Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 41 40 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.95
(-5.03 to -0.87)
-3.78
(-5.94 to -1.59)
-5.58
(-7.74 to -3.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 60 Minutes
Comments

Due to item #2 error, analyses were done in the following manner to check robustness:

All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).

The 72 data points were removed & the negative score for affected subjects & visits were not calculated.

The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average.

Type of Statistical Test Superiority
Comments Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.
Statistical Test of Hypothesis P-Value 0.0848
Comments P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 20 Minutes
Comments

Due to item #2 error, analyses were done in the following manner to check robustness:

All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).

The 72 data points were removed & the negative score for affected subjects & visits were not calculated.

The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average.

Type of Statistical Test Superiority
Comments Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.
Statistical Test of Hypothesis P-Value 0.5930
Comments P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.
8.Post-Hoc Outcome
Title Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4
Hide Description

The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.

This analysis outcome approach took Incorrect Item #2 and imputed using worst possible value.

Time Frame Day 4, Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes
Hide Arm/Group Description:

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Overall Number of Participants Analyzed 41 40 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.29
(-4.24 to -0.34)
-3.50
(-5.49 to -1.51)
-5.36
(-7.36 to -3.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 60 Minutes
Comments

Due to item #2 error, analyses were done in the following manner to check robustness:

All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).

The 72 data points were removed & the negative score for affected subjects & visits were not calculated.

The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average.

Type of Statistical Test Superiority
Comments Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.
Statistical Test of Hypothesis P-Value 0.0307
Comments P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LFMS Sham, LFMS 20 Minutes
Comments

Due to item #2 error, analyses were done in the following manner to check robustness:

All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).

The 72 data points were removed & the negative score for affected subjects & visits were not calculated.

The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average.

Type of Statistical Test Superiority
Comments Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.
Statistical Test of Hypothesis P-Value 0.3907
Comments P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.
Method ANCOVA
Comments P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.
Time Frame Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
Adverse Event Reporting Description “# affected” for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx & original tx assignment creates a higher exposure to LFMS Sham in Week 2. The “# at risk” for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
 
Arm/Group Title LFMS Sham LFMS 20 Minutes LFMS 60 Minutes LFMS 120 Min - Week 2
Hide Arm/Group Description

For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.

LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

All-Cause Mortality
LFMS Sham LFMS 20 Minutes LFMS 60 Minutes LFMS 120 Min - Week 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)      0/40 (0.00%)      0/41 (0.00%)      0/41 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
LFMS Sham LFMS 20 Minutes LFMS 60 Minutes LFMS 120 Min - Week 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/79 (0.00%)      0/40 (0.00%)      0/41 (0.00%)      0/41 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LFMS Sham LFMS 20 Minutes LFMS 60 Minutes LFMS 120 Min - Week 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/79 (25.32%)      14/40 (35.00%)      13/41 (31.71%)      10/41 (24.39%)    
Ear and labyrinth disorders         
Tinnitus  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Eye disorders         
Lacrimation increased  1  0/79 (0.00%)  0 0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Gastrointestinal disorders         
Nausea  1  1/79 (1.27%)  1 1/40 (2.50%)  1 1/41 (2.44%)  1 0/41 (0.00%)  0
Abdominal pain  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Diarrhoea  1  3/79 (3.80%)  3 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
General disorders         
Fatigue  1  1/79 (1.27%)  1 2/40 (5.00%)  2 1/41 (2.44%)  1 1/41 (2.44%)  1
Pyrexia  1  2/79 (2.53%)  2 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Infections and infestations         
Gasrtoenteritis  1  0/79 (0.00%)  0 0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Gasrtoenteritis viral  1  0/79 (0.00%)  0 0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Nasopharyngitis  1  2/79 (2.53%)  2 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Upper respiratory tract infecrion  1  1/79 (1.27%)  1 0/40 (0.00%)  0 1/41 (2.44%)  1 1/41 (2.44%)  1
Cellulitis  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Ear infection viral  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Nasopharyngitis  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 1/41 (2.44%)  1
Sinusitis  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Ligament sprain  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Procedural headache  1  0/79 (0.00%)  0 1/40 (2.50%)  2 0/41 (0.00%)  0 0/41 (0.00%)  0
Procedural pain  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Eye contusion  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Traumatic arthropathy  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Investigations         
Blood creatinine increased  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Metabolism and nutrition disorders         
Vitamin B12 deficiency  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Neck pain  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Pain in extremity  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Musculoskeletal chest pain  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Musculoskeletal pain  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Muscle spasm  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Nervous system disorders         
Headche  1  7/79 (8.86%)  10 6/40 (15.00%)  7 4/41 (9.76%)  4 4/41 (9.76%)  6
Somnolence  1  0/79 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Head Discomfort  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Dizziness  1  1/79 (1.27%)  1 1/40 (2.50%)  1 3/41 (7.32%)  3 1/41 (2.44%)  2
Psychiatric disorders         
Insomnia  1  2/79 (2.53%)  2 0/40 (0.00%)  0 2/41 (4.88%)  3 1/41 (2.44%)  1
Abnormal dreams  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Agitation  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Anxiety  1  0/79 (0.00%)  0 0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Depression  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  1/79 (1.27%)  1 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Sinus congestion  1  1/79 (1.27%)  2 0/40 (0.00%)  0 0/41 (0.00%)  0 0/41 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hair disorder  1  0/79 (0.00%)  0 0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Pruritis  1  0/79 (0.00%)  0 0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Vascular disorders         
Hypertension  1  0/79 (0.00%)  0 0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
The study was not powered for secondary measures. Statistical significance for group-wise comparisons wasn't expected.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Atul Pande, MD, Chief Medical Officer
Organization: Tal Medical
Responsible Party: Tal Medical, Inc.
ClinicalTrials.gov Identifier: NCT02452892     History of Changes
Other Study ID Numbers: TAL-02-007
First Submitted: May 19, 2015
First Posted: May 25, 2015
Results First Submitted: July 21, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017