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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
| Medical University of South Carolina | OTHER |
| Ralph H. Johnson VA Medical Center | FED |
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The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is effective in the treatment of suicidal thinking in individuals with a depressive episode and either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or both conditions.
Evidence suggests that depression in general, and suicidal ideation in particular, results from a dysfunctional regulatory pathway involving prefrontal cortical governance over limbic activity. Repeated daily non-invasive stimulation of the prefrontal cortex with TMS would theoretically strengthen and reset this cortical control pathway and reduce suicidal ideation and restore healthy circuit behavior.
The aim of the current study is to assess the efficacy of TMS therapy in the treatment of suicidal ideation in patients with depressive episode(s) and either PTSD or mild TBI or both. It is hypothesized that participants who receive repetitive TMS (Group 1) relative to sham treatment (Group 2) three times daily over three days will evidence more improvement in suicidal ideation from baseline to the end of day 3. Participants will be followed for six months following treatment to assess safety and long-term efficacy of TMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Group 1: The treatment group will receive the following dose of repetitive TMS delivered over the left prefrontal cortex: 10 Hz, 120% Motor Threshold, 5 second pulse train, 10 second intertrain (IT) interval, 30 minutes of treatment, 6000 pulses per session; three sessions each day (18,000 stimuli) for three days for a total of 54,000 stimuli. |
| Measure | Description | Time Frame |
|---|---|---|
| Scale of Suicidal Ideation | baseline to Day 3 of TMS treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | -adverse events, study study discontinuation due to adverse events, & decrease in cognitive function as measured by significant change on neuropsychological measures | baseline through 6-month follow-up. |
| long-term efficacy of TMS |
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Inclusion Criteria:
Veteran inpatients aged 18-70 years inclusive, with a depressive episode.
Must also have either or both
Admitted because of suicidal ideation.
SSI score > 12.
HRSD question #3 > 3.
Female subjects of childbearing potential must have a negative urine pregnancy test.
Comorbid (non-principal) diagnoses of psychiatric disorders not explicitly listed in the following Exclusion Criteria section are generally permitted (with final eligibility determination by Site Principal Investigator clinical assessment).
Subjects must be able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
After full explanation of the study, subjects must demonstrate their willingness to participate by signing the informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S George, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States | ||
| Ralph H. Johnson VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24731434 | Derived | George MS, Raman R, Benedek DM, Pelic CG, Grammer GG, Stokes KT, Schmidt M, Spiegel C, Dealmeida N, Beaver KL, Borckardt JJ, Sun X, Jain S, Stein MB. A two-site pilot randomized 3 day trial of high dose left prefrontal repetitive transcranial magnetic stimulation (rTMS) for suicidal inpatients. Brain Stimul. 2014 May-Jun;7(3):421-31. doi: 10.1016/j.brs.2014.03.006. Epub 2014 Mar 19. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2015 | |
| Reset | Sep 24, 2015 | |
| Release | Feb 23, 2016 |
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| Walter Reed National Military Medical Center |
| FED |
| University of California, San Diego | OTHER |
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|
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| Transcranial Magnetic Stimulation - Sham Comparator | Device | The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days. |
|
-length of current hospital stay along with Scale of Suicidal Ideation score, rehospitalization rates, and suicide completion rates over 6 months of follow-up |
| baseline through 6-month follow-up |
| Charleston |
| South Carolina |
| 29401 |
| United States |
| Reset | Mar 18, 2016 |
| Release | Aug 29, 2016 |
| Reset | Oct 21, 2016 |
| Release | Aug 9, 2022 |
| Reset | Aug 30, 2022 |
| Release | Mar 9, 2023 |
| Reset | Apr 3, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2015 | Sep 24, 2015 | |||
| Feb 23, 2016 | Mar 18, 2016 | |||
| Aug 29, 2016 | Oct 21, 2016 | |||
| Aug 9, 2022 | Aug 30, 2022 | |||
| Mar 9, 2023 | Apr 3, 2023 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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