Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation
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|ClinicalTrials.gov Identifier: NCT01212848|
Recruitment Status : Unknown
Verified April 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium.
Recruitment status was: Active, not recruiting
First Posted : October 1, 2010
Last Update Posted : April 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depressive Episode Posttraumatic Stress Disorder Traumatic Brain Injury||Device: Transcranial Magnetic Stimulation Device: Transcranial Magnetic Stimulation - Sham Comparator||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients With PTSD|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||October 2013|
Device: Transcranial Magnetic Stimulation
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.
Other Name: Neuronetics
|Sham Comparator: Sham||
Device: Transcranial Magnetic Stimulation - Sham Comparator
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 [ Time Frame: baseline through 6-month follow-up. ]-adverse events, study study discontinuation due to adverse events, & decrease in cognitive function as measured by significant change on neuropsychological measures
- long-term efficacy of TMS [ Time Frame: baseline through 6-month follow-up ]-length of current hospital stay along with Scale of Suicidal Ideation score, rehospitalization rates, and suicide completion rates over 6 months of follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212848
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center|
|Charleston, South Carolina, United States, 29401|
|Principal Investigator:||Mark S George, MD||Medical University of South Carolina|