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TMS for Suicidal Crisis in Active Duty SMs (TMS4SI)

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ClinicalTrials.gov Identifier: NCT03014362
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : February 21, 2018
Sponsor:
Collaborators:
Congressionally Directed Medical Research Programs
Augusta University
The Geneva Foundation
Information provided by (Responsible Party):
Christopher Hines, Eisenhower Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Suicide Suicidal Ideation Suicidal Impulses Suicidal Intention Suicidal and Self-Injurious Behavior Suicidal Depression Device: Neuronetics NeuroStar XPLOR magnetic stimulator - Active Device: Neuronetics NeuroStar XPLOR magnetic stimulator - Sham Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. Change in Suicidal Ideation [ Time Frame: Baseline, 1month, 3 months & 6 months ]
    Beck Scale for Suicide Ideation (BSS)


Secondary Outcome Measures :
  1. Impact on Depressive symptoms [ Time Frame: Baseline, 1month, 3 months & 6 months ]
    RAND SF-36

  2. Impact on post-traumatic anxiety [ Time Frame: Baseline, 1month, 3 months & 6 months ]
    Posttraumatic Stress Disorder Checklist (PCL-5)

  3. Impact on Quality of Life measures [ Time Frame: Baseline, 1month, 3 months & 6 months ]
    Public Health Questionnaire (PQL)


Other Outcome Measures:
  1. Impact on Healthcare Utilization [ Time Frame: 6 months ]
    Hospital Emergency room visits and admission/re-admission for any behavioral health reason



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014362


Contacts
Contact: Christopher E Hines, MD 706-787-8134 christopher.e.hines.civ@mail.mil
Contact: Scott R Mooney, PhD, ABPP 706-787-2677 scott.r.mooney.civ@mail.mil

Locations
United States, Georgia
Eisenhower Army Medical Center Recruiting
Augusta, Georgia, United States, 30905
Sponsors and Collaborators
Eisenhower Army Medical Center
Congressionally Directed Medical Research Programs
Augusta University
The Geneva Foundation
Investigators
Principal Investigator: Christopher E Hines, MD Eisenhower Army Medical Center

Responsible Party: Christopher Hines, Chief, DDEAMC Outpatient Behavioral Health, Eisenhower Army Medical Center
ClinicalTrials.gov Identifier: NCT03014362     History of Changes
Other Study ID Numbers: 1604023
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms