TMS for Suicidal Crisis in Active Duty SMs

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.

Conditions

• Suicide
• Suicidal Ideation
• Suicidal Impulses
• Suicidal Intention
• Suicidal and Self-Injurious Behavior
• Suicidal Depression

Interventions

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.

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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs

  collaborator FED

• Augusta University

  collaborator OTHER

• The Geneva Foundation

  collaborator OTHER

• Eisenhower Army Medical Center

  lead FED

Principal Investigators

• Christopher E Hines, MD · Eisenhower Army Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-12

Primary Completion

2020-01-10

Completion

2021-09-10

FDA Device

Yes

Countries

• United States

Study Locations