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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisenhower Army Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Augusta University
The Geneva Foundation
Congressionally Directed Medical Research Programs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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