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Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD

NCT02458521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-11-20

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Transcranial Magnetic Stimulation

Treatment will consist of 30 sessions of TMS over approximately 7 weeks. More specifically, the active or 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. TMS sessions will consist of both 10 Hz left pre-frontal stimulation for 3,500 pulses followed by 1 Hz right pre-frontal stimulation for 1,500 pulses per session, for a total stimulation time of approximately one hour per session. These pulse sequences have theoretical targets that may be implicated in conditions of poor resiliency, apathy, depression and anxiety.

DEVICE

Sham Transcranial Magnetic Stimulation

Treatment will consist of 30 sessions of TMS over approximately 7 weeks. More specifically, the active or 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. The TMS system will have three coils, one designated active and the other two unlabeled and identical in appearance, weight, and noises emitted, one of which will be active and one of which will be sham.

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Geoffrey G Grammer, M.C. · National Intrepid Center of Excellence

  • Paul F Pasquina, M.D. · Walter Reed National Military Medical Center

  • Louis M French, Psy.D · Walter Reed National Military Medical Center

  • Nancy de Almeida, RN · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-05-31
Completion
2019-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02458521 on ClinicalTrials.gov