Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury, Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT02458521

Run by

Walter Reed National Military Medical Center

People needed

60

Starts

2015-08-01

Expected to finish

2019-05-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Military health care beneficiary for enrollment (loss of benefits will not require separation from the study).
• Over the age of 18 years.
• Presence of mTBI (based on standard Veterans Affairs (VA)/ Department of Defense (DoD) criteria).
• Presence of PTSD symptoms (PCL score over 30).

You may not qualify if…

• Evidence of moderate or severe TBI (based on standard VA/DoD criteria). Incidental neuroimaging findings that may or may not be related to trauma (e.g. white matter hyperintensities on structural MRI) are not sufficient to identify a subject as a moderate TBI if other severity markers fall in the mild TBI range.
• History of seizure, bipolar disorder, schizophrenia, or current dependence to psychoactive substance(s).
• History of severe or recent heart disease.
• Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain.
• Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs which may protect against seizure occurrence.
• Not a suitable candidate for the study as determined by the PI.
• Pregnancy or plans to become pregnant during the course of the study (determined via urine-pregnancy test).
• Presence of metallic hardware in close contact to the discharging coil (e.g. cochlear implants, internal pulse generator).
• Presence of implanted brain electrodes (cortical or deep-brain electrodes).
• MRI portion: Presence of metal fragments or devices (cardiac pacemaker, neural stimulator, etc.), which are determined by a radiologist to contraindicate MRI (at 3 Tesla). Also, presence of metal (such as dental braces) which causes significant degradation of the MRI signal.

Where it is running

• National Intrepid Center of Excellence, Walter Reed National Military Medical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.