Clinical trial NCT03014362: TMS for Suicidal Crisis in Active Duty SMs
Official title: Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicidal Ideation
Suicidal Impulses
Suicidal Intention
Suicidal and Self-Injurious Behavior
Suicidal Depression
Lead sponsor: Eisenhower Army Medical Center
Sponsor class: FED
Collaborators: name: Congressionally Directed Medical Research Programs
name: Augusta University
name: The Geneva Foundation
First posted: 2017-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Suicidal Ideation (Acute)
timeFrame: Change over the active treatment course ie. the 3 days of active treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Eisenhower Army Medical Center
state: Georgia
Study officials:
affiliation: Eisenhower Army Medical Center
name: Christopher E Hines, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hines CE, Mooney S, Watson NL, Looney SW, Wilkie DJ. Repetitive Transcranial Magnetic Stimulation Promotes Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members. J ECT. 2022 Jun 1;38(2):103-109. doi: 10.1097/YCT.0000000000000810.