TMS for Suicidal Crisis in Active Duty SMs
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/23/2018 |
| Start Date: | June 12, 2017 |
| End Date: | December 2019 |
| Contact: | Christopher E Hines, MD |
| Email: | christopher.e.hines.civ@mail.mil |
| Phone: | 706-787-8134 |
Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
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.
(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.
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.
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.
Inclusion Criteria:
- All Active Duty SMs (regardless of sex, ethnicity, sexual or religious orientation)
who are admitted to Eisenhower Army Medical Center (EAMC) Inpatient Psychiatric
Service (IPS) with active suicidality or elevated risk for suicide regardless of most
psychiatric diagnostic co-morbidity (see exclusion criteria). This includes in-patient
admissions for suicidality and outpatient SMs with a Columbia-Suicide Severity Rating
Scale (C-SSRS) score ≥3.
- Age 18 to 60
- Able to speak and read English.
Exclusion Criteria:
- Combative with staff.
- Comatose/catatonia.
- Incapacity owing to active mania or psychosis.
- Epilepsy, multiple sclerosis, or cerebrovascular accident.
- Non-removable metal in the head (Shrapnel; plates, aneurysm coils/clips; metal tattoos
etc.)
- Implantable devices (pacemakers, stimulators, etc.)
- Schizophrenic or borderline personality.
- Positive screen for pregnancy.
- Already receiving TMS as a treatment for depression.
- Non-English reading and speaking subjects
We found this trial at
1
site
Click here to add this to my saved trials
