Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD

N/A

Waitlist Available

Led By Paul F Pasquina, M.D.

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured to compare changes from baseline; during weeks 2, 4, 6 of treatment; and during the month 1, month 2, and month 3 follow up visits after treatment ends.

Summary

The overall objective of this project is to determine the efficacy and tolerability of TMS for mild Traumatic Brain Injury (mTBI) with PTSD symptoms and correlate treatment response with anatomical and biological factors unique to each service member (SM). Exploratory work will be done to look at the neuronal and biological changes that may occur over the course of TMS treatment.

Eligible Conditions

Post-Traumatic Stress Disorder
Traumatic Brain Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured to compare changes from baseline; during weeks 2, 4, 6 of treatment; and during the month 1, month 2, and month 3 follow up visits after treatment ends.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured to compare changes from baseline; during weeks 2, 4, 6 of treatment; and during the month 1, month 2, and month 3 follow up visits after treatment ends.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured to compare changes from baseline; during weeks 2, 4, 6 of treatment; and during the month 1, month 2, and month 3 follow up visits after treatment ends. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD Check List-Civilian (PCL-C)

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

Secondary study objectives

Beck Scale for Suicide Ideation (BSS)

Mayo-Portland Adaptability Inventory-Military Edition (MPAI-m)

Mental Depression

+1 more

Other study objectives

Automated Neuropsychological Assessment Metrics (ANAM)

Biomarker Assessment: Blood Samples

Biomarker Assessment: Saliva Samples

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcranial Magnetic StimulationExperimental Treatment1 Intervention

TMS sessions will consist of both 10Hz left pre-frontal stimulation for 3,500 pulses followed by 1Hz right pre-frontal stimulation for 1,500 pulses per session, for a total stimulation time of approximately one hour per session.

Group II: Sham Transcranial Magnetic StimulationPlacebo Group1 Intervention

Sham TMS treatments will be conducted five times a week for 5 consecutive weeks, followed by a tapering of three sessions during week 6 and two sessions during week 7.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

Do I qualify?Apply below to find out