Traumatic Brain InjuryNCT02458521
Transcranial Magnetic Stimulation (TMS) to Treat mTBI and PTSD
A study testing Transcranial Magnetic Stimulation in people with Traumatic Brain Injury and Post-Traumatic Stress Disorder, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Post-Traumatic Stress Disorder
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Intrepid Center of Excellence, Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Ariana C Gover-Chamlou, BA, 301-319-8148, ariana.gover-chamlou.ctr@mail.mil
Nancy de Almeida, RN, 3014001234, nancy.k.dealmeida.ctr@mail.mil
About this study
Official title: A Study of Bilateral Prefrontal Transcranial Magnetic Stimulation (TMS) to Treat the Symptoms of Mild TBI (mTBI) and PTSD
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.
Read the 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.
- 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:
- To assess whether TMS results in an improvement in mood as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR), general life functioning (physical, cognitive, emotional, behavioral, and social problems) as measured by the Mayo-Portland Adaptability Inventory - military (MPAI-m), life satisfaction as measured by the Satisfaction With Life Scale (SWLS), and suicidality as measured by the Beck Scale for Suicidal Ideation (BSS). Hypothesis: TMS will result in an improvement in mood, general life functioning, and life satisfaction, as well as a reduction in suicidality.
- To assess the durability of any improvement realized by TMS over the course of three months following the conclusion of sessions. Hypothesis: The improvement realized by 7 weeks of TMS will prove stable, showing effects up to 3 months after the conclusion of active treatment.
- To assess structural neuronal changes over the course of active vs. sham TMS as measured by MRI. Hypothesis 1: Analysis of structural MRI (3D T1-weighted) will reveal increased volume of the hippocampus and anterior cingulate cortex in service members who improve in PTSD symptoms (as measured by the PCL-C). Hypothesis 2: Microstructural MRI (DTI) will reveal FA increase in the corpus callosum and the uncinated fasciculus in service members who improve in measures of mTBI (i.e., Rivermead Post Concussion Symptoms Questionnaire).
- To assess metabolic neuronal changes that occur over the course of active vs. sham TMS as measured by PET. Hypothesis 1: TMS will result in increased glucose uptake in the ipsilateral and contralateral cerebral hemispheres for those who show significant improvements in the symptomatic measures of TBI (i.e. RPQ and MPAI-m). Hypothesis 2: TMS will result in decreased glucose uptake in the dorsal anterior cingulate/mid cingulate cortex (dACC/MCC) and in the bilateral amygdala for those service members with significant improvements in the symptomatic measures of PTSD and mood (i.e. PTSD Checklist and QIDS-SR).
- To examine the mechanism of action of TMS through looking at the metabolic changes that occur during a TMS session. Hypothesis: There will be increased glucose uptake in the left prefrontal cortex and decreased glucose uptake in the right prefrontal cortex immediately after active TMS as compared to sham.
- Exploratory: To assess biological changes that result from TMS therapy and to determine how biomarkers relate to changes in PTSD symptoms.
- Exploratory: To examine how single gene polymorphisms (SNPs) in serotonin genes may relate to TMS response and symptom change.
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation |
| Sham Transcranial Magnetic Stimulation | Sham comparator | 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. Receives: Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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)
QIDS-SR is a shortened version of the Inventory of Depressive Symptomatology, Self-report (IDS-SR) that covers just items that assess DSM-IV criterion diagnostic symptoms for depression. The QIDS-SR contains 16 items that separate into the nine DSM-IV symptom domains of (1) sadness (2) concentration (3) self-criticism (4) suicidal ideation (5) interest (6) energy/fatigue (7) sleep disturbance (8) decrease/increase in appetite/weight and (9) psychomotor agitation/retardation. Research indicates that the IDS-SR has high internal consistency and shows convergent validity with the IDS-SR and the Hamilton Rating Scale for Depression (HAM-D).
Measured: 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)
The BSS is a measure that quantifies the intensity of current conscious suicidal intent by scaling various dimensions of self-destructive thoughts or desires. The BSS has been shown to have high internal consistency, construct validity, and be sensitive to changes in depression and hopelessness.
Measured: 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)
The MPAI-m is a modified version of the Mayo-Portland Adaptability Inventory-Fourth Edition (MPAI-4), which has been shown to have internal consistency, construct validity, predictive validity, sensitivity to treatment effects, and have convergent validity with the Disability Rating Scale and the Rancho Scale. The MPAI-m is a reliable measure that shows satisfactory construct validity in the assessment of functional abilities and activity in military members with mild TBI.
Measured: 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)
The SWLS is designed to measure satisfaction with life as a whole. The measure consists of marking agreement on a scale from 1 (strongly disagree) to 7 (strongly agree) on five items pertaining to general life satisfaction. The SWLS has been shown to possess good convergent validity with other scales and assessments of subjective well-being, temporal stability, sensitivity to changes in life satisfaction over the course of clinical intervention, and discriminant validity from emotional well-being measures.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Responsible party
- Sponsor
- Investigators
- Geoffrey G Grammer, M.C., Study chair, National Intrepid Center of ExcellencePaul F Pasquina, M.D., Principal investigator, Walter Reed National Military Medical CenterLouis M French, Psy.D, Study chair, Walter Reed National Military Medical CenterNancy de Almeida, RN, Study chair, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458521
- Sponsor's protocol ID
- Protocol # [397662]
- Other IDs
- CNRM 0048
- Status last verified
- Nov 2015
- First submitted
- 30 Apr 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Bilateral Prefrontal Transcranial Magnetic Stimulation (TMS) to Treat the Symptoms of Mild TBI (mTBI) and PTSD
- ClinicalTrials.gov ID
- NCT02458521
- Acronym / sponsor ID
- Protocol # [397662]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- Aug 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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:
- To assess whether TMS results in an improvement in mood as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR), general life functioning (physical, cognitive, emotional, behavioral, and social problems) as measured by the Mayo-Portland Adaptability Inventory - military (MPAI-m), life satisfaction as measured by the Satisfaction With Life Scale (SWLS), and suicidality as measured by the Beck Scale for Suicidal Ideation (BSS). Hypothesis: TMS will result in an improvement in mood, general life functioning, and life satisfaction, as well as a reduction in suicidality.
- To assess the durability of any improvement realized by TMS over the course of three months following the conclusion of sessions. Hypothesis: The improvement realized by 7 weeks of TMS will prove stable, showing effects up to 3 months after the conclusion of active treatment.
- To assess structural neuronal changes over the course of active vs. sham TMS as measured by MRI. Hypothesis 1: Analysis of structural MRI (3D T1-weighted) will reveal increased volume of the hippocampus and anterior cingulate cortex in service members who improve in PTSD symptoms (as measured by the PCL-C). Hypothesis 2: Microstructural MRI (DTI) will reveal FA increase in the corpus callosum and the uncinated fasciculus in service members who improve in measures of mTBI (i.e., Rivermead Post Concussion Symptoms Questionnaire).
- To assess metabolic neuronal changes that occur over the course of active vs. sham TMS as measured by PET. Hypothesis 1: TMS will result in increased glucose uptake in the ipsilateral and contralateral cerebral hemispheres for those who show significant improvements in the symptomatic measures of TBI (i.e. RPQ and MPAI-m). Hypothesis 2: TMS will result in decreased glucose uptake in the dorsal anterior cingulate/mid cingulate cortex (dACC/MCC) and in the bilateral amygdala for those service members with significant improvements in the symptomatic measures of PTSD and mood (i.e. PTSD Checklist and QIDS-SR).
- To examine the mechanism of action of TMS through looking at the metabolic changes that occur during a TMS session. Hypothesis: There will be increased glucose uptake in the left prefrontal cortex and decreased glucose uptake in the right prefrontal cortex immediately after active TMS as compared to sham.
- Exploratory: To assess biological changes that result from TMS therapy and to determine how biomarkers relate to changes in PTSD symptoms.
- Exploratory: To examine how single gene polymorphisms (SNPs) in serotonin genes may relate to TMS response and symptom change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic StimulationTMS 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 comparator | Device: Sham Transcranial Magnetic StimulationSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationTreatment 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 | Transcranial Magnetic Stimulation |
| Sham Transcranial Magnetic StimulationTreatment 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. | Device | Sham Transcranial Magnetic Stimulation |
Primary outcome
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.
4 secondary outcomes
Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey G Grammer, M.C. study chair
National Intrepid Center of Excellence
Paul F Pasquina, M.D. principal investigator
Walter Reed National Military Medical Center
Louis M French, Psy.D study chair
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Traumatic Brain Injury and Post-Traumatic Stress Disorder, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Pasquina, M.D. (301-310-2460, Paul.f.pasquina.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.