Recruiting

TMS

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT02458521

Conditions

Traumatic Brain Injury

Post-Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Study Details

Brief 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

Traumatic Brain Injury

Post-Traumatic Stress Disorder

Study ID

NCT02458521

Start date

Aug, 2015

Status verified date

Nov, 2015

Completion date

May, 2019

Anticipated

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. History of seizure, bipolar disorder, schizophrenia, or current dependence to psychoactive substance(s).
3. History of severe or recent heart disease.
4. Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain.
5. Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs which may protect against seizure occurrence.
6. Not a suitable candidate for the study as determined by the PI.
7. Pregnancy or plans to become pregnant during the course of the study (determined via urine-pregnancy test).
8. Presence of metallic hardware in close contact to the discharging coil (e.g. cochlear implants, internal pulse generator).
9. Presence of implanted brain electrodes (cortical or deep-brain electrodes).
10. 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Magnetic Stimulation

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.

sham comparator: Sham Transcranial Magnetic Stimulation

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.

Interventions

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.

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.

Primary outcome measure

  • Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: Measured to compare changes from Baseline; during weeks 2, 4, and 6 of treatment; and during the Month 1, Month 2, and Month 3 follow up visits after treatment ends. ]
  • PTSD Check List-Civilian (PCL-C) [ Time Frame: Measured to compare changes from Baseline; during weeks 2, 4, and 6 of treatment; and during the Month 1, Month 2, and Month 3 follow up visits after treatment ends. ]

Central Contacts and Locations

Central contacts

Locations

National Intrepid Center of Excellence, Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Nov 20, 2015

Last verified

Nov, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2015-11-20.