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Behavioural Intervention
Transcranial Magnetic Stimulation for Traumatic Brain Injury
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.
Awards & highlights
Study 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
- Traumatic Brain Injury
- Post-Traumatic Stress Disorder
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTSD Check List-Civilian (PCL-C)
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Secondary outcome measures
Beck Scale for Suicide Ideation (BSS)
Mayo-Portland Adaptability Inventory-Military Edition (MPAI-m)
Mental Depression
+1 moreOther outcome measures
Automated Neuropsychological Assessment Metrics (ANAM)
Biomarker Assessment: Blood Samples
Biomarker Assessment: Saliva Samples
+3 moreTrial 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
Find a Location
Who is running the clinical trial?
Center for Neuroscience and Regenerative Medicine (CNRM)FED
23 Previous Clinical Trials
5,307 Total Patients Enrolled
Walter Reed National Military Medical CenterLead Sponsor
138 Previous Clinical Trials
33,954 Total Patients Enrolled
Louis M French, Psy.DStudy ChairWalter Reed National Military Medical Center
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