Suicide Clinical Trial
— TMS4SIOfficial title:
Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
Verified date | September 2022 |
Source | Eisenhower Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 10, 2021 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Eisenhower Army Medical Center | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Eisenhower Army Medical Center | Augusta University, Congressionally Directed Medical Research Programs, The Geneva Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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