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TMS for Suicidal Crisis in Active Duty SMs (TMS4SI)

Primary Purpose

Suicide, Suicidal Ideation, Suicidal Impulses

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuronetics NeuroStar XPLOR magnetic stimulator - Active
Neuronetics NeuroStar XPLOR magnetic stimulator - Sham
Sponsored by
Eisenhower Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eisenhower Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TMS active

TMS sham

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in Suicidal Ideation (Acute)
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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2016
Last Updated
September 12, 2022
Sponsor
Eisenhower Army Medical Center
Collaborators
Congressionally Directed Medical Research Programs, Augusta University, The Geneva Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03014362
Brief Title
TMS for Suicidal Crisis in Active Duty SMs
Acronym
TMS4SI
Official Title
Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eisenhower Army Medical Center
Collaborators
Congressionally Directed Medical Research Programs, Augusta University, The Geneva Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation, Suicidal Impulses, Suicidal Intention, Suicidal and Self-Injurious Behavior, Suicidal Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS active
Arm Type
Active Comparator
Arm Description
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).
Arm Title
TMS sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuronetics NeuroStar XPLOR magnetic stimulator - Active
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neuronetics NeuroStar XPLOR magnetic stimulator - Sham
Intervention Description
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 Outcome Measure Information:
Title
Change in Suicidal Ideation (Acute)
Description
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.
Time Frame
Change over the active treatment course ie. the 3 days of active treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher E Hines, MD
Organizational Affiliation
Eisenhower Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eisenhower Army Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35613009
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.
Results Reference
derived

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TMS for Suicidal Crisis in Active Duty SMs

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