Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD
A Study of Bilateral Prefrontal Transcranial Magnetic Stimulation (TMS) to Treat the Symptoms of Mild TBI (mTBI) and PTSD
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedNovember 20, 2015
November 1, 2015
2.8 years
April 30, 2015
November 19, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
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.
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)
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.
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.
Secondary Outcomes (4)
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.
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.
Other Outcomes (6)
Pain Rating
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.
Automated Neuropsychological Assessment Metrics (ANAM)
Will be administered 3 times to compare changes from (1) Baseline (within 30 days of initiating TMS or Sham treatment); (2) prior to a session during week 2 of TMS or Sham treatment; and (3) at the completion of TMS or Sham treatment (week 7).
Structural Neuronal Changes to be assessed by MRI Assessment
Measured at Baseline and compared to results at completion of treatment (week 7).
- +3 more other outcomes
Study Arms (2)
Transcranial Magnetic Stimulation
EXPERIMENTALTMS 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 Transcranial Magnetic Stimulation
SHAM COMPARATORSham 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
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Intrepid Center of Excellence, Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Geoffrey G Grammer, M.C.
National Intrepid Center of Excellence
- PRINCIPAL INVESTIGATOR
Paul F Pasquina, M.D.
Walter Reed National Military Medical Center
- STUDY CHAIR
Louis M French, Psy.D
Walter Reed National Military Medical Center
- STUDY CHAIR
Nancy de Almeida, RN
Walter Reed National Military Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
June 1, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2019
Last Updated
November 20, 2015
Record last verified: 2015-11