TMS for Suicidal Crisis in Active Duty SMs
TMS4SI
Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2016
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2021
CompletedResults Posted
Study results publicly available
September 28, 2022
CompletedSeptember 28, 2022
September 1, 2022
2.6 years
November 30, 2016
March 28, 2022
September 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change over the active treatment course ie. the 3 days of active treatment
Study Arms (2)
TMS active
ACTIVE COMPARATORNeuronetics 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).
TMS sham
SHAM COMPARATORNeuronetics 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.
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- Age 18 to 60
- Able to speak and read English.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisenhower Army Medical Centerlead
- Congressionally Directed Medical Research Programscollaborator
- Augusta Universitycollaborator
- The Geneva Foundationcollaborator
Study Sites (1)
Eisenhower Army Medical Center
Augusta, Georgia, 30905, United States
Related Publications (1)
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.
PMID: 35613009DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher E Hines, MD
- Organization
- Walter Reed National Military Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher E Hines, MD
Eisenhower Army Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, DDEAMC Outpatient Behavioral Health
Study Record Dates
First Submitted
November 30, 2016
First Posted
January 9, 2017
Study Start
June 12, 2017
Primary Completion
January 10, 2020
Study Completion
September 10, 2021
Last Updated
September 28, 2022
Results First Posted
September 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share