Skip to main content
OpenTrials
Completed

NCT Number: NCT03014362

TMS for Suicidal Crisis in Active Duty SMs

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eisenhower Army Medical Center

Augusta, Georgia, 30905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuronetics NeuroStar XPLOR magnetic stimulator - Active

Device

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.

Neuronetics NeuroStar XPLOR magnetic stimulator - Sham

Device

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.

Primary outcomes

  1. Change in Suicidal Ideation (Acute)

    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.

Sponsors and collaborators

Lead sponsor

Eisenhower Army Medical Center

Fed

Collaborators

  • Augusta University
  • Congressionally Directed Medical Research Programs
  • The Geneva Foundation

Registry information

Official study title

Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members

Acronym: TMS4SI

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 9, 2017
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.