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Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder (NEST-MDD)

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ClinicalTrials.gov Identifier: NCT01370733
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : July 14, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
NeoSync, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Device: NEST-1 (NeoSync EEG Synchronized TMS)
Device: SHAM
Enrollment 202
Recruitment Details Enrollment occurred across 17 study sites (both academic and private clinical locations), initiated in May 2012 and all subject visits complete by July 2013. Three sites discontinued early due to departure of the Principal Investigator or due to a loss of contributing staff personnel. None were discontinued specifically due to a lack of enrollment.
Pre-assignment Details Upon study closure, 291 subjects were consented for possible study participation with 202 of those subjects subsequently enrolled and randomized to treatment. Those entering the study at Screening while currently on an antidepressant required a minimum 1-week wash out period prior to completing a Baseline (Day 0) visit.
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Period Title: Overall Study
Started 103 99
Completed 86 77
Not Completed 17 22
Reason Not Completed
Withdrawal by Subject             8             8
Lost to Follow-up             3             0
Adverse Event             2             4
Lack of Efficacy             3             5
Physician Decision             0             2
Protocol Violation             1             3
Arm/Group Title Active sTMS Sham Total
Hide Arm/Group Description

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Total of all reporting groups
Overall Number of Baseline Participants 103 99 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 99 participants 202 participants
46.1  (11.3) 45.7  (12.2) 45.9  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 202 participants
Female
62
  60.2%
66
  66.7%
128
  63.4%
Male
41
  39.8%
33
  33.3%
74
  36.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 202 participants
American Indian / Alaskan Native 0 2 2
Asian 5 3 8
Black or African American 6 8 14
Hispanic or Latino 6 6 12
Native Hawaiian or Other Pacific Islander 1 0 1
White 82 79 161
Other or Unknown 3 1 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 103 participants 99 participants 202 participants
103 99 202
Baseline Mean Hamilton Rating Scale for Depression (HAM-D17)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 103 participants 99 participants 202 participants
21.94  (3.46) 21.15  (3.25) 21.55  (3.37)
[1]
Measure Description:

For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials.

The HAM-D17 score ranges from 0-52; a score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

Length of Current Episode in Months  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 103 participants 99 participants 202 participants
10.9  (6.8) 10.8  (6.7) 10.85  (6.73)
Antidepressant Exposure in Current Episode   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 202 participants
Inadequate Dose/Duration of >= 1 Medication 11 13 24
Intolerant of >= 1 Medication 10 5 15
Treatment Naive (ATHF 0) 40 37 77
Adequate Trial of >= 1 Medication 61 65 126
[1]
Measure Description: Subjects were asked about previous antidepressant exposure in the current episode. It was possible to select more than one correct response in assessing antidepressant history.
Education Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 202 participants
Some high school or less 2 1 3
High school diploma 19 7 26
Vocational school 1 2 3
Some college 17 31 48
College degree 42 42 84
Professional or Graduate degree 21 15 36
Unknown 1 1 2
1.Primary Outcome
Title Mean HAM-D17 Total Score Change (Intent to Treat - All)
Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 103 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.49  (7.25) -6.97  (6.28)
2.Primary Outcome
Title Mean HAM-D17 Total Score Change (Per Protocol - All)
Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 59 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.00  (6.54) -6.56  (5.85)
3.Secondary Outcome
Title Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)
Hide Description

All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change.

This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response.

Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population - Non-Naive Subjects
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.58  (6.93) -4.25  (4.75)
4.Secondary Outcome
Title Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)
Hide Description

For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used.

This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 103 99
Measure Type: Number
Unit of Measure: participants
27 25
5.Secondary Outcome
Title Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)
Hide Description

For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6.

This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: participants
20 18
6.Secondary Outcome
Title Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)
Hide Description

The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).

This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population - Non-Naive Subjects
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 38 36
Measure Type: Number
Unit of Measure: participants
13 3
7.Secondary Outcome
Title Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)
Hide Description

The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used.

This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 103 99
Measure Type: Number
Unit of Measure: participants
11 14
8.Secondary Outcome
Title Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)
Hide Description

For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6.

This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Time Frame Baseline to End of Double-Blind Treatment Period (up to week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 59 61
Measure Type: Number
Unit of Measure: participants
9 10
9.Secondary Outcome
Title Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)
Hide Description

The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).

This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population.

The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Time Frame Baseline to End of Double-Blind Treatment Period (Week 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population - Non-Naive Subjects
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description:

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

Overall Number of Participants Analyzed 38 36
Measure Type: Number
Unit of Measure: participants
5 2
Time Frame All subject Adverse Events are tracked from the signing of Informed Consent through 4 weeks after the double-blind acute phase has been completed or Early Termination.
Adverse Event Reporting Description Primarily systematic assessments, some reporting was unsolicited although minimal.
 
Arm/Group Title Active sTMS Sham
Hide Arm/Group Description

Treatment with the NEST-1 Device

NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.

Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device

SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.

All-Cause Mortality
Active sTMS Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active sTMS Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/103 (1.94%)      1/99 (1.01%)    
Gastrointestinal disorders     
Hospitalization (Dehydration)  1  1/103 (0.97%)  1 0/99 (0.00%)  0
Psychiatric disorders     
Hospitalization (Suicide Attempt)  1  0/103 (0.00%)  0 1/99 (1.01%)  1
Hospitalization (Risk of Self Harm)  1  1/103 (0.97%)  1 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Active sTMS Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/103 (77.67%)      42/99 (42.42%)    
Ear and labyrinth disorders     
Tinnitus  1  3/103 (2.91%)  1/99 (1.01%) 
Eye disorders     
Visual Disturbance  1  3/103 (2.91%)  0/99 (0.00%) 
Gastrointestinal disorders     
Dyschezia  1  3/103 (2.91%)  2/99 (2.02%) 
Non-Specific GI Discomfort  1  4/103 (3.88%)  3/99 (3.03%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  9/103 (8.74%)  4/99 (4.04%) 
Hand/Arm/Shoulder Pain  1  3/103 (2.91%)  0/99 (0.00%) 
Leg and Foot Pain  1  4/103 (3.88%)  0/99 (0.00%) 
Nervous system disorders     
Agitation  1  4/103 (3.88%)  1/99 (1.01%) 
Dizziness  1  4/103 (3.88%)  2/99 (2.02%) 
Headache  1  22/103 (21.36%)  19/99 (19.19%) 
Paresthesia  1  4/103 (3.88%)  0/99 (0.00%) 
Psychiatric disorders     
Insomnia  1  7/103 (6.80%)  5/99 (5.05%) 
Lack of Energy  1  3/103 (2.91%)  0/99 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Infection  1  7/103 (6.80%)  5/99 (5.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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. Andrew Leuchter, MD
Organization: University of California Los Angeles
Phone: (310) 825-0207
EMail: afl@ucla.edu
Responsible Party: NeoSync, Inc.
ClinicalTrials.gov Identifier: NCT01370733     History of Changes
Other Study ID Numbers: NND3001
First Submitted: June 8, 2011
First Posted: June 10, 2011
Results First Submitted: June 2, 2015
Results First Posted: July 14, 2015
Last Update Posted: October 26, 2015