PTSDNCT01625962
Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)
An observational study of PTSD, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 2 sites in United States.
Trial summary
This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- PTSD
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Mar 2016
- Phase
- Observational
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Service members who have sustained mild TBI or extracranial injury (ECI), and have received care at Walter Reed National Military Medical Center or Fort Belvoir Community Hospital.
Who may be able to join
- Injured while deployed or stateside
- Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria
- For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
- Aged 18-50
- Defense Enrollment Eligibility Reporting System (DEERS) eligible
Who cannot join
- Unable or unwilling to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization ("unable" includes cases in which the potential subject cannot read and understand English well enough to provide informed consent)
- Penetrating head injury
- Medical chart reveals a history of significant neurological condition(s) (reviewed on a case by case basis)
- Diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis)
- History of major psychiatric condition(s) that interfere with daily functioning as revealed in the medical chart or by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
- Record of drug or alcohol abuse or dependence in the past six months as documented in medical history review
- Medical chart or SCID reveals current or lifetime PTSD diagnosis related to non-combat life events that occurred prior to most recent deployment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
Official title: Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury
This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of PTSD symptoms, which will be measured at baseline, 3 months, and 6 months.
- Conditions
- PTSD
- Keywords
- PTSD, mTBI, mild TBI, extracranial injury, ECI, Brain Indices
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mTBI | Service members who have sustained "impact-induced mTBI" or "blast-induced mTBI" (n = 74 completers) | |
| ECI | Service members who have sustained an extracranial injury (ECI) with no evidence of TBI (n = 32 completers) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS)
To evaluate the associations between (1) baseline indices of brain structure and function and (2) course of PTSD symptoms in service members with TBI and ECI over the 6-month follow-up period.
Measured: Change between Baseline and 3-months and 6-months
Secondary outcomes (2)
Correlation between brain structure and function and cognitive, functional, headache, behavioral and quality of life measures
To evaluate the associations between (1) the selected baseline indices of brain structure and function, and (2) course of post-concussive symptoms, self-reported health status, including headache, overall emotional distress, and quality of life over the 6-month follow-up period.
Measured: Change between Baseline and 3-months and 6-months
Evaluate effect of injury type and brain structure and function
To evaluate the effect of type of injury (impact TBI vs. blast TBI vs. ECI) on selected indices of brain structure and function at baseline and at the 6-month follow-up period.
Measured: Change between Baseline and 3-months and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Connie C. Duncan, PhD, Principal investigator, Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625962
- Sponsor's protocol ID
- INTRuST-BRI
- Status last verified
- Aug 2015
- First submitted
- 20 Jun 2012
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01625962
- Acronym / sponsor ID
- INTRuST-BRI
- Conditions
- PTSD
- Keywords
- PTSD, mTBI, mild TBI, extracranial injury, ECI, Brain Indices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical ConsortiumUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jun 2012 (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.
This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of PTSD symptoms, which will be measured at baseline, 3 months, and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTBI | – | –Service members who have sustained "impact-induced mTBI" or "blast-induced mTBI" (n = 74 completers) |
| ECI | – | –Service members who have sustained an extracranial injury (ECI) with no evidence of TBI (n = 32 completers) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Service members who have sustained mild TBI or extracranial injury (ECI), and have received care at Walter Reed National Military Medical Center or Fort Belvoir Community Hospital.
Key inclusion criteria (5 listed)
- Injured while deployed or stateside
- Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria
- For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
- Aged 18-50
- Defense Enrollment Eligibility Reporting System (DEERS) eligible
Key exclusion criteria (7 listed)
- Unable or unwilling to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization ("unable" includes cases in which the potential subject cannot read and understand English well enough to provide informed consent)
- Penetrating head injury
- Medical chart reveals a history of significant neurological condition(s) (reviewed on a case by case basis)
- Diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis)
- History of major psychiatric condition(s) that interfere with daily functioning as revealed in the medical chart or by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS)
Time frame: Change between Baseline and 3-months and 6-months
To evaluate the associations between (1) baseline indices of brain structure and function and (2) course of PTSD symptoms in service members with TBI and ECI over the 6-month follow-up period.
2 secondary outcomes
Correlation between brain structure and function and cognitive, functional, headache, behavioral and quality of life measures
Time frame: Change between Baseline and 3-months and 6-months
Evaluate effect of injury type and brain structure and function
Time frame: Change between Baseline and 3-months and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Yes
Related trials for PTSD
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Connie C. Duncan, PhD principal investigator
Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University of the Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 2 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS) (time frame: Change between Baseline and 3-months and 6-months). 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 1 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.