Eisenhower Army Medical Center
Augusta, Georgia, 30905, United States
NCT Number: NCT03014362
The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and medication therapies. There will be 6 months of follow-up, in order to establish the ongoing and lasting therapeutic effect of TMS.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Augusta, Georgia, 30905, United States
The programmatic-level objective of the study is to address the goals of the Army STARRS Program and the Suicide Prevention for America's Veterans Act through implementation of an effective acute treatment for patients psychiatrically admitted in suicidal crisis as well as other patients at high-risk for suicide. This is achieved by application of TMS, which provides a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects and less incapacitation than current treatments such as ECT and pharmacologic therapies. A recent study led by the senior consultant of this proposal demonstrated tolerance and efficacy for a new, high-dose regimen of TMS in a VA population with an average age of 47. The objective of the proposed study is to extend the application of TMS to a younger population of Active Duty Service Members (SM) in order to demonstrate efficacy for returning veterans of the Middle East wars, in particular, as well as the civilian young adult population. TMS dosage in the proposed study is recalibrated to commercially-standard levels in order to provide consistency with devices currently in clinical operation. In addition, follow-up in the proposed study continues for 6 months in order to establish persistence and durability of the therapeutic effect of TMS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes.
Treatment Dose: ~4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
Time frame: Change over the active treatment course ie. the 3 days of active treatment
The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.
Eisenhower Army Medical Center
Fed
Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
Acronym: TMS4SI
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