TMS for Suicidal Crisis in Active Duty SMs (TMS4SI)

September 12, 2022 updated by: Christopher Hines, Eisenhower Army Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30905
        • Eisenhower Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TMS active

Neuronetics NeuroStar XPLOR magnetic stimulator - Active;

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 (Standard of Care).
Device: Neuronetics NeuroStar XPLOR magnetic stimulator - Active

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.
SHAM_COMPARATOR: TMS sham

Neuronetics NeuroStar XPLOR magnetic stimulator - Sham;

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.
Device: Neuronetics NeuroStar XPLOR magnetic stimulator - Sham
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change over the active treatment course ie. the 3 days of active treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisenhower Army Medical Center

Collaborators

Augusta University
The Geneva Foundation
Congressionally Directed Medical Research Programs

Investigators

  • Principal Investigator: Christopher E Hines, MD, Eisenhower Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2017

Primary Completion (ACTUAL)

January 10, 2020

Study Completion (ACTUAL)

September 10, 2021

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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