A Phase 3 interventional study of Transcranial Magnetic Stimulation and Transcranial Magnetic Stimulation - Sham Comparator in Depressive Episode, Posttraumatic Stress Disorder and Traumatic Brain Injury, sponsored by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-26.
Sponsored by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Phase 3, Interventional, and Treatment
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.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 42 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Must also have either or both
Exclusion Criteria:
Device: Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation - Sham Comparator
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.
Also known as: Neuronetics
The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days.
Scale of Suicidal Ideation
Time frame: baseline to Day 3 of TMS treatment
Safety and tolerability
-adverse events, study study discontinuation due to adverse events, \& decrease in cognitive function as measured by significant change on neuropsychological measures
Time frame: baseline through 6-month follow-up.
long-term efficacy of TMS
-length of current hospital stay along with Scale of Suicidal Ideation score, rehospitalization rates, and suicide completion rates over 6 months of follow-up
Time frame: baseline through 6-month follow-up
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium