A Study of Bilateral Prefrontal Transcranial Magnetic Stimulation (TMS) to Treat the Symptoms of Mild TBI (mTBI) and PTSD
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Study Overview
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.
Detailed Description
The primary objectives of this study are:
- To assess the change on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) and the PTSD Check List-Civilian Version (PCL-C) administered pre-treatment, then bi-weekly (weeks 2, 4, 6) during a 7 week treatment course, then monthly for 3 months following treatment.
Hypothesis: The addition of high frequency left pre-frontal and low frequency right pre-frontal cortical stimulation will improve symptom reporting on the RPQ and PCL-C in service members with mTBI and PTSD symptoms as compared to sham treatment. 2. To assess the tolerability of TMS in subjects as measured by side effects in active TMS compared with sham treatment.
Hypothesis: TMS will prove safe and tolerable in service members with mTBI and PTSD.
The secondary objectives of this study are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Transcranial Magnetic Stimulation (Device)
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.
Intervention: Sham Transcranial Magnetic Stimulation (Device)
Outcomes
Primary Outcomes
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.
The RPQ gauges the severity of post-concussion symptoms. The subject rates thMeasured 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.e degree to which 16 symptoms are more of a problem compared with premorbid levels from 0 (not experienced at all) to 4 (a severe problem). The questionnaire has been shown to have good test-retest reliability.
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.
The PCL-C is a self-report questionnaire on the presence and severity of PTSD symptoms. The questionnaire asks subjects how much they are affected by each of 17 PTSD symptoms in the last month on a scale ranging from 1 (not at all) to 5 (extremely) to yield a total PTSD symptom severity score and subscale scores on (a) re-experiencing (b) avoidance (c) arousal. The PCL-C has been shown to demonstrate excellent internal consistency and convergent validity with other measures of PTSD.
Secondary Outcomes
- Beck Scale for Suicide Ideation (BSS)(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.)
- Mayo-Portland Adaptability Inventory-Military Edition (MPAI-m)(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.)
- Satisfaction with Life Scale (SWLS)(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.)
- Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)(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.)