NCT01212848

Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients With PTSD

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Depressive Episode
• Posttraumatic Stress Disorder
• Traumatic Brain Injury

Interventions

Type	Name	Description
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.
DEVICE	Transcranial Magnetic Stimulation - Sham Comparator	The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-03-01
• Completion: 2013-10-01
• First posted: 2010-10-01
• Last updated: 2013-04-26

Locations

2 sites across 1 country: United States