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Multiple Treatment Study Using Low Field Magnetic Stimulation for Bipolar Depression (LFMS)

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ClinicalTrials.gov Identifier: NCT01929681
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : June 27, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Michael Rohan, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Bipolar Depression
Intervention Device: Low Field Magnetic Stimulation
Enrollment 53
Recruitment Details Recruitment was performed through newspaper advertisement, posting, and referral
Pre-assignment Details Subjects that failed exclusion criteria for variable criteria such as medications change or drug use were permitted to reapply for participation after a washout period of at least 1 month.
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Period Title: Overall Study
Started 28 25
Completed 26 24
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             0
Physician Decision             1             1
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment Total
Hide Arm/Group Description

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Total of all reporting groups
Overall Number of Baseline Participants 28 25 53
Hide Baseline Analysis Population Description
Three enrolled subjects did not complete.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 25 participants 53 participants
44.5  (13.5) 45.7  (10.3) 45.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 53 participants
Female
13
  46.4%
10
  40.0%
23
  43.4%
Male
15
  53.6%
15
  60.0%
30
  56.6%
Montgomery-Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants 25 participants 53 participants
28.2  (5.8) 27.4  (5.0) 27.8  (5.4)
[1]
Measure Description: The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total.
1.Primary Outcome
Title Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.
Time Frame Variable based on screening visit schedule, > 2 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects completing 3 treatments and 1 visit
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description:

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-14.03  (7.85) -9.75  (9.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS - Active Treatment, LFMS - Sham Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.049
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Primary Outcome
Title Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
Hide Description PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.
Time Frame 90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
subjects completing 3 treatment visits and 1 followup visit
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description:

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (5.8) 1.4  (5.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS - Active Treatment, LFMS - Sham Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.182
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
Hide Description PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (<30min oost treatment) minus pre (<30min pre treatment) score differences for the three treatment days
Time Frame Over 3 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects completing 3 treatments and 1 visit
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description:

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Overall Number of Participants Analyzed 26 24
Mean (Standard Error)
Unit of Measure: units on a scale
linear coefficient -0.471  (0.594) -0.375  (0.648)
day 1 mean 0.50  (1.14) 1.40  (1.09)
day 2 mean -0.63  (0.68) 0.21  (0.91)
day 3 mean -0.44  (0.65) 0.65  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS - Active Treatment, LFMS - Sham Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.449
Comments [Not Specified]
Method Regression, Linear
Comments Mixed effects analysis
4.Secondary Outcome
Title Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days
Time Frame Over 3 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects completing 3 treatments and 1 visit
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description:

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Overall Number of Participants Analyzed 26 24
Mean (Standard Error)
Unit of Measure: units on a scale
linear coefficient -5.42  (1.07) -5.60  (1.07)
day 1 mean 26.15  (1.47) 26.13  (1.44)
day 2 mean 16.81  (1.31) 17.83  (1.45)
day 3 mean 15.31  (1.69) 14.92  (1.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS - Active Treatment, LFMS - Sham Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.444
Comments [Not Specified]
Method Regression, Linear
Comments Mixed effects analysis
5.Secondary Outcome
Title Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale
Hide Description PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days
Time Frame Over 3 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects completing 3 treatments and 1 visit
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description:

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Overall Number of Participants Analyzed 26 24
Mean (Standard Error)
Unit of Measure: units on a scale
linear coefficient 1.70  (1.39) 0.80  (1.10)
day 1 mean 21.00  (1.82) 22.25  (1.34)
day 2 mean 24.04  (1.95) 23.54  (1.53)
day 3 mean 24.40  (2.21) 23.85  (1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LFMS - Active Treatment, LFMS - Sham Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.182
Comments [Not Specified]
Method Regression, Linear
Comments Mixed effects analysis
Time Frame Adverse events data was collected over a period of 3 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LFMS - Active Treatment LFMS - Sham Treatment
Hide Arm/Group Description

Low Field Magnetic Stimulation (LFMS) active treatment

Active low field magnetic stimulation treatment applied with the LFMS Device; the device is on and magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

Low Field Magnetic Stimulation - sham treatment

Inactive low field magnetic stimulation (no stimulation) treatment applied with the LFMS Device; the device is on, however no magnetic field stimulation is present.

Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.

All-Cause Mortality
LFMS - Active Treatment LFMS - Sham Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
LFMS - Active Treatment LFMS - Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/24 (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 - Active Treatment LFMS - Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      0/24 (0.00%)    
Psychiatric disorders     
insomnia  [1]  1/26 (3.85%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
A night of insomnia reported the night after the second of three treatments
Study was designed for 72 subjects but only 50 subjects were completed due to lack of funds.
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. Michael Rohan
Organization: McLean Hospital
Phone: 617-855-3127
Responsible Party: Michael Rohan, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01929681     History of Changes
Other Study ID Numbers: 2012P002380
First Submitted: July 23, 2013
First Posted: August 28, 2013
Results First Submitted: April 11, 2017
Results First Posted: June 27, 2017
Last Update Posted: September 26, 2017