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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH098174-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Neuronetics | OTHER |
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The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Active Comparator | 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. |
|
| Sham rTMS | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS) | Device | 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms at 4 Weeks | 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 | 4 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Symptoms at 4 Weeks- Secondary | 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 | 4 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan F Taylor, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29494898 | Derived | Taylor SF, Ho SS, Abagis T, Angstadt M, Maixner DF, Welsh RC, Hernandez-Garcia L. Changes in brain connectivity during a sham-controlled, transcranial magnetic stimulation trial for depression. J Affect Disord. 2018 May;232:143-151. doi: 10.1016/j.jad.2018.02.019. Epub 2018 Feb 21. |
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44 patients were screened in person and 40 consented for the study.
Subjects were recruited between October 2013 and October 2015. Subjects exhibited moderate levels of treatment resistance
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | 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. |
| FG001 | Sham rTMS | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data for completers only, since this is the group entered into the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS | 20 active sessions |
| BG001 | Sham rTMS | 20 sham sessions |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms at 4 Weeks | 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 | Posted | Mean | Standard Deviation | units on a scale | 4 weeks after baseline |
|
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Adverse events assessed during 4 weeks of double-blinded treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | 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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Taylor | University of Michigan | 734-936-4955 | sftaylor@umich.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
| Withdrawal by Subject |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MADRS | 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 | Mean | Standard Deviation | units on a scale |
|
| HRSD-17 | 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 | Mean | Standard Deviation | units on a scale |
|
| Global assessment of Function (GAF) | Range: 0 - 100 Severely impaired: < 30 moderate impaired: 30-50 mild impaired: 50- 80 No impairment: > 80 | Mean | Standard Deviation | units on a scale |
|
| Antidepressant Treatment History Form (ATHF-current) | 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 | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
|
| Secondary | Depression Symptoms at 4 Weeks- Secondary | 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 | 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 | Posted | Mean | Standard Deviation | units on a scale | 4 weeks after baseline |
|
|
|
|
| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | Sham rTMS | 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. | 0 | 17 | 5 | 17 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| parathesia | Nervous system disorders | Systematic Assessment |
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| Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| lower extremity swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| URI symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D001523 |
| Mental Disorders |