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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03014362
Other study ID # 1604023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2017
Est. completion date September 10, 2021

Study information

Verified date September 2022
Source Eisenhower Army Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Eisenhower Army Medical Center Augusta Georgia

Sponsors (4)

Lead Sponsor Collaborator
Eisenhower Army Medical Center Augusta University, Congressionally Directed Medical Research Programs, The Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

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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