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Imaging Biomarkers for TMS Treatment of Depression

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ClinicalTrials.gov Identifier: NCT01900314
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Neuronetics
Information provided by (Responsible Party):
Stephan Taylor, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Depression
Intervention Device: repetitive Transcranial Magnetic Stimulation (rTMS)
Enrollment 40
Recruitment Details Subjects were recruited between October 2013 and October 2015. Subjects exhibited moderate levels of treatment resistance
Pre-assignment Details 44 patients were screened in person and 40 consented for the study.
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period.

repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.

repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Period Title: Overall Study
Started 20 20
Completed MRI#1 [1] 17 [2] 17 [3]
Completed 16 [4] 16 [5]
Not Completed 4 4
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             0             1
Withdrawal by Subject             3             3
[1]
MRI required BEFORE first treatment
[2]
2 withdrew consent prior to MRI, 1 had MRI technical failure
[3]
2 withdrew consent, 1 patient was unable to tolerate MRI
[4]
1 patient had MRI, then moved away after 5 TMS treatments
[5]
1 patient had 4 TMS Tx, but missed too many for protocol requirements,
Arm/Group Title Active rTMS Sham rTMS Total
Hide Arm/Group Description 20 active sessions 20 sham sessions Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
Baseline data for completers only, since this is the group entered into the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
46.9  (10.7) 44.1  (11.1) 45.5  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
11
  68.8%
10
  62.5%
21
  65.6%
Male
5
  31.3%
6
  37.5%
11
  34.4%
MADRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 16 participants 32 participants
25.4  (5.7) 21.9  (3.1) 23.5  (5.1)
[1]
Measure Description: MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression
HRSD-17   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 16 participants 32 participants
16  (3.9) 13.1  (2.3) 14.2  (4.4)
[1]
Measure Description: Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22
Global assessment of Function (GAF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 16 participants 32 participants
52.6  (4.7) 55.6  (4.3) 54.1  (4.6)
[1]
Measure Description:

Range: 0 - 100

Severely impaired: < 30 moderate impaired: 30-50 mild impaired: 50- 80 No impairment: > 80

Antidepressant Treatment History Form (ATHF-current)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 16 participants 32 participants
2.56  (1.75) 2.94  (1.77) 2.75  (1.74)
[1]
Measure Description:

ATHF is obtained from interview and review of all treatments, with scores obtained based on the type, duration and length of treatment. This figure represents total number of medications and acceptable augmentation strategies, for the current episode.

Range: 0 - infinite

Interpretations: More is worse

1.Primary Outcome
Title Depressive Symptoms at 4 Weeks
Hide Description MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression
Time Frame 4 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:
20 active sessions of rTMS
20 sham sessions
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.6  (8.3) 15.6  (8.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active rTMS, Sham rTMS
Comments Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Depression Symptoms at 4 Weeks- Secondary
Hide Description Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22
Time Frame 4 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Sample analyzed included all participants who entered the study and received MRI scans at baseline and after 4 weeks of treatment. Repeated measures ANCOVA with screening MADRS score as co-variate
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description:
20 active sessions
20 sham sessions
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.1  (4.8) 10.1  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active rTMS, Sham rTMS
Comments Repeated measures ANCOVA with baseline MADRS as co-variate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse events assessed during 4 weeks of double-blinded treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active rTMS Sham rTMS
Hide Arm/Group Description

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.

repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.

repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

All-Cause Mortality
Active rTMS Sham rTMS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (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 Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/17 (23.53%)      5/17 (29.41%)    
Musculoskeletal and connective tissue disorders     
Pain   2/17 (11.76%)  3 1/17 (5.88%)  1
Nervous system disorders     
Headache   0/17 (0.00%)  0 2/17 (11.76%)  2
Fatigue   0/17 (0.00%)  0 1/17 (5.88%)  1
Insomnia   2/17 (11.76%)  3 1/17 (5.88%)  1
parathesia   2/17 (11.76%)  3 0/17 (0.00%)  0
Renal and urinary disorders     
Incontinence   1/17 (5.88%)  1 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
URI symptoms   1/17 (5.88%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
lower extremity swelling   1/17 (5.88%)  1 0/17 (0.00%) 
Indicates events were collected by systematic assessment
Small size, not powered for group differences. Primary measure was not clinical, but brain changes (primary measures for this report have only focused on clinical changes as neural changes cannot be entered into this reporting format
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Stephan Taylor
Organization: University of Michigan
Phone: 734-936-4955
EMail: sftaylor@umich.edu
Layout table for additonal information
Responsible Party: Stephan Taylor, University of Michigan
ClinicalTrials.gov Identifier: NCT01900314     History of Changes
Other Study ID Numbers: HUM00053677
1R21MH098174-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2013
First Posted: July 16, 2013
Results First Submitted: January 9, 2017
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017