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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoSync, Inc.
ClinicalTrials.gov Identifier:
NCT01370733
First received: June 8, 2011
Last updated: June 18, 2015
Last verified: June 2015
Results First Received: June 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Device: NEST-1 (NeoSync EEG Synchronized TMS)
Device: SHAM

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Active sTMS

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.

Sham

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.


Participant Flow:   Overall Study
    Active sTMS     Sham  
STARTED     103     99  
COMPLETED     86     77  
NOT COMPLETED     17     22  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active sTMS

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.

Sham

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 Total of all reporting groups

Baseline Measures
    Active sTMS     Sham     Total  
Number of Participants  
[units: participants]
  103     99     202  
Age  
[units: years]
Mean (Standard Deviation)
  46.1  (11.3)     45.7  (12.2)     45.9  (11.7)  
Gender  
[units: participants]
     
Female     62     66     128  
Male     41     33     74  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
     
United States     103     99     202  
Baseline Mean Hamilton Rating Scale for Depression (HAM-D17) [1]
[units: units on a scale]
Mean (Standard Deviation)
  21.94  (3.46)     21.15  (3.25)     21.55  (3.37)  
Length of Current Episode in Months  
[units: months]
Mean (Standard Deviation)
  10.9  (6.8)     10.8  (6.7)     10.85  (6.73)  
Antidepressant Exposure in Current Episode [2]
[units: 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  
Education Level  
[units: 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]

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.

[2] 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.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean HAM-D17 Total Score Change (Intent to Treat - All)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

2.  Primary:   Mean HAM-D17 Total Score Change (Per Protocol - All)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

3.  Secondary:   Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

4.  Secondary:   Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

5.  Secondary:   Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

6.  Secondary:   Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

7.  Secondary:   Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]

8.  Secondary:   Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (up to week 6) ]

9.  Secondary:   Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)   [ Time Frame: Baseline to End of Double-Blind Treatment Period (Week 6) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: afl@ucla.edu


No publications provided


Responsible Party: NeoSync, Inc.
ClinicalTrials.gov Identifier: NCT01370733     History of Changes
Other Study ID Numbers: NND3001
Study First Received: June 8, 2011
Results First Received: June 2, 2015
Last Updated: June 18, 2015
Health Authority: United States: Institutional Review Board