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Antidepressant Mechanisms of Transcranial Magnetic Stimulation

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ClinicalTrials.gov Identifier: NCT02466230
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Neuronetics
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Device: Repetitive transcranial magnetic stimulation
Enrollment 28
Recruitment Details Participant Flow of the Overall Study.
Pre-assignment Details 28 subjects were enrolled and all completed the study.
Arm/Group Title Active rTMS
Hide Arm/Group Description

Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Active rTMS
Hide Arm/Group Description

Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
41.9  (15.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
19
  67.9%
Male
9
  32.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
2
   7.1%
Not Hispanic or Latino
26
  92.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   7.1%
White
26
  92.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
 100.0%
Hamilton Depression Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants
27.6  (6.5)
[1]
Measure Description: The Hamilton Depression Rating Scale is 24 items with total scores ranging from 0-76. Higher scores indicate greater severity of depression. (0-7 = None; 8-13 = Mild; 14-18 = Moderate; 19-23 = Severe; 23 and higher = very severe). Total scores are reported with no subscales.
Patient Health Questionnaire - 9 (PHQ-9)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants
14.3  (8.4)
[1]
Measure Description: Self-rated scale of symptoms of depression. Nine items with a maximum score of 27. Higher score means more severe depression (0-4 = None; 5-9 = Mild; 10-14 = Moderate; 15-19 = Severe; 20 and higher = Very Severe).
1.Primary Outcome
Title Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item)
Hide Description The Hamilton Depression Rating Scale is 24 items with total scores ranging from 0-76. Higher scores indicate greater severity of depression. (0-7 = None; 8-13 = Mild; 14-18 = Moderate; 19-23 = Severe; 23 and higher = very severe). Total scores are reported with no subscales.
Time Frame Change in score on Hamilton Depression Rating Scale from baseline to immediately after the final rTMS treatment (5 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active rTMS
Hide Arm/Group Description:

Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.2  (7.7)
2.Secondary Outcome
Title Depression Severity Measured by the Public Health Questionnaire-9
Hide Description Self-rated scale of symptoms of depression. Nine items with a maximum score of 27. Higher score means more severe depression (0-4 = None; 5-9 = Mild; 10-14 = Moderate; 15-19 = Severe; 20 and higher = Very Severe).
Time Frame Change in score in Public Health Questionnaire-9 from baseline to immediately after the final rTMS treatment (5 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All 28 subjects completed the study but two subjects did not complete the final PHQ-9 assessment.
Arm/Group Title Active rTMS
Hide Arm/Group Description:

Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.7  (6.3)
3.Other Pre-specified Outcome
Title Gamma-amino-butyric Acid Level Measured by Magnetic Resonance Spectroscopy
Hide Description Percent change in medial prefrontal gamma-amino-butyric acid level
Time Frame Baseline to immediately after the final rTMS treatment (5 weeks)
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Glutamate Level Measured by Magnetic Resonance Spectroscopy
Hide Description Percent change in medial prefrontal glutamate level
Time Frame Baseline to immediately after the final rTMS treatment (5 weeks)
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Cortical Thickness Measured by T1 Magnetic Resonance Imaging
Hide Description Percent change in medial prefrontal average cortical thickness
Time Frame Baseline to immediately after the final rTMS treatment (5 weeks)
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Fractional Anisotropy Measured by Diffusion Tensor Imaging
Hide Description Percent change in medial prefrontal average fractional anisotropy
Time Frame Baseline to immediately after the final rTMS treatment (5 weeks)
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Functional Connectivity Measured by Functional Magnetic Resonance Imaging
Hide Description Percent change in medial prefrontal average functional connectivity
Time Frame Baseline to immediately after the final rTMS treatment (5 weeks)
Outcome Measure Data Not Reported
Time Frame Five weeks (25 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active rTMS
Hide Arm/Group Description

Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system will be administered. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

Repetitive transcranial magnetic stimulation: Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.

All-Cause Mortality
Active rTMS
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Active rTMS
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active rTMS
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Marc Dubin, M.D.
Organization: Weill Cornell Medical College
Phone: (212) 746-5817
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02466230     History of Changes
Other Study ID Numbers: 1101011475
First Submitted: May 28, 2015
First Posted: June 9, 2015
Results First Submitted: July 12, 2018
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018