TBINCT04012463
Neural and Behavioral Sequelae of Blast-Related Traumatic Brain Injury
An observational study of TBI, run by Baylor College of Medicine.
Trial summary
Hypothesis 1: On fMRI scanning, frontoparietal activation during performance of executive function tasks of working memory, inhibitory control processes, and stimulus-response interference will exhibit greater signal intensity, a wider spatial extent, and more bilateral activation in chronic MTBI than chronic OI… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- TBI
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to May 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This is a prospective, observational study using a cross-sectional design to compare brain imaging and neuropsychological findings at 12 to 72 months post-injury in four groups of at least 30 patients each: two groups of military patients who have sustained mild to moderate TBI (milMTBI) or orthopedic injury or uninjured veterans, reservists, or service members (milControl) and two groups of civilian patients who had MTBI (civMTBI) or OI (civOI).
Who may be able to join
- 1. GCS score 9-15 (if available) 2. Brain injury due to blast 3. Current age 18-45 4. Right-handed 5. Post-injury interval 12-72 months 6. Duration of Loss of Consciousness (LOC) < 24 hours 7. Duration of Posttraumatic Amnesia (PTA)< 7 days 8. No intracranial surgery 9. No brain lesions on computer tomography (CT) scan (if available) 10. Extracranial Injuries by Abbreviated Injury Scale (AIS) <3 (non-head)
- 1. GCS score 9-15 (if available) 2. Non-blast brain injury 3. Current age 18-45 4. Right-handed 5. Post-injury interval 12-72 months 6. LOC < 24 hours 7. PTA< 7 days 8. No intracranial surgery 9. No brain lesions on CT scan (if available) 10. Extracranial Injuries by AIS <3 (non-head)
- 1. No history of brain injury 2. Non-blast extracranial injury or no injury 3. Current age 18-45 4. Right-handed 5. Post-injury interval 12-72 months 6. LOC -none 7. PTA- none 8. No intracranial surgery 9. CT scan normal (if done) 10. Extracranial Injuries by AIS <3 (non-head)
Who cannot join
- 1) Not fluent in English 2) Non-right hande 3) AIS score equal or higher 4 for body parts other than head 4) Neurologic deficit other than TBI (MTBI, OI groups); no LOC or PTA (MTBI groups) 5) Blood alcohol level > 200 mg/dL 6) Previous hospitalization for head injury 7) Pregnancy when screened prior to brain imaging 8) Pre-existing neurologic disorder associated with cerebral dysfunction and/or cognitive deficit (e.g., cerebral palsy, mental retardation, epilepsy) or diagnosed dyslexia 9) Pre-existing severe psychiatric disorder (bipolar disorder, schizophrenia) as determined by the Structured Clinical Interview for Depression 10) Penetrating gunshot wound to the brain 11) Contraindications to undergoing MRI, including implant of metal or marked agitation observed by research assistant. 12) Illegal alien 13) Hypoxia for 30 minutes or longer after resuscitation PO2 < 96 mmHg 14) Hypotension for 30 minutes or longer after resuscitation (systolic blood pressure more than 2SDs below mean for age)
About this study
Hypothesis 1: On fMRI scanning, frontoparietal activation during performance of executive function tasks of working memory, inhibitory control processes, and stimulus-response interference will exhibit greater signal intensity, a wider spatial extent, and more bilateral activation in chronic MTBI than chronic OI participants.
Hypothesis 2: DTI changes, characterized by lower FA and higher MD at the gray-white junction, corpus callosum, central semiovale, and internal capsule, will be seen in MTBI but not in OI subjects.
Read more
Hypothesis 3: Increased fMRI activation in chronic MTBI will be correlated with location and severity of disrupted fiber tracks that subserve neural networks associated with each fMRI activation task.
Hypothesis 4: Performance on computerized neuropsychological testing (ANAM) and reaction time measures on fMRI tasks will better discriminate MTBI from OI than standard paper-and pencil tests.
Hypothesis 5: The combination of fMRI, DTI, and ANAM will better discriminate MTBI from OI than each individual method.
Hypothesis 6: More severe brain pathology in MTBI, as measured by neuroimaging (fMRI, DTI) and ANAM test scores, will be associated with less severe PTSD and symptoms.
Read the detailed description
Traumatic brain injuries (TBI) are a common occurrence from roadside blasts of improvised explosive devices (IEDs). Like civilian TBI, blast-related TBI can result from mechanical forces in which objects in motion strike the head or the head is forcefully put into motion and strikes an object. TBI from exposure to an explosive blast may also result from a third cause: barotrauma. Blasts produce wave-induced changes in atmospheric pressure, which in turn produce characteristic injuries to vulnerable bodily regions at air-fluid interfaces, such as the middle ear. It is unknown whether the neural and cognitive sequelae of blast-related TBI differ from those resulting from mechanically-induced TBI commonly observed in civilian accidents. Understanding the potentially unique sequelae of blast-related TBI is critical for accurate diagnosis and designing effective pharamacological and neurorehabilitation interventions.
In the proposed cross-sectional study, we aim to apply neurobehavioral testing and advanced MRI techniques [task-activated functional MRI (fMRI) and diffusion tensor imaging (DTI)] to gain a comprehensive understanding of the neural changes underlying blast-related MTBI. This will be accomplished by comparing neurobehavioral and neuroimaging findings obtained from military personnel who have experienced a blast injury with those obtained from civilians who have experienced TBI from motor vehicle accidents and from military and civilian control participants with orthopedic injuries. We will accomplish this goal by conducting advanced neuroimaging (task-activated fMRI and DTI fiber tracking) and neurobehavioral testing (computerized assessment and standard neuropsychological testing) on 120 chronic trauma patients: 30 military MTBI patients who have experienced blast injuries, 30 civilian MTBI patients with mechanical closed head injuries, and 30 military and 30 civilian patients with orthopedic injuries.
- Conditions
- TBI
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation on Stop Signal Reaction Time Task (SSRT)
fMRI measuring brain activation associated with performance of SSRT
Measured: 12-24 months post-injury
Brain activation on Sternberg Item Recognition Task (SIRT)
fMRI measuring brain activation associated with performance of SIRT
Measured: 12-24 months post-injury
Secondary outcomes (7)
Neurobehavioral Symptom Inventory
self-report of various domains of emotional status
Measured: 12-24 months post-injury
Post-traumatic Symptom Checklist-Civilian (PCL-C)
Checklist of posttraumatic stress symptoms
Measured: 12-24 months post-injury
Center for the Epidemiological Center for Study of Depression (CES-D)
Self-report measure of depression
Measured: 12-24 months post-injury
Symbol Digit Modalities Test (SDMT)
Measure of processing speed
Measured: 12-24 months post-injury
Trail Making Test A and B
Measure of visuoperceptive performance and speed
Measured: 12-24 months post-injury
Controlled Oral Word Association
Measure of verbal fluency
Measured: 12-24 months post-injury
California Verbal Learning Test 2
Verbal learning test
Measured: 12-24 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study startJun 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBIStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Harvey Levin, Baylor College of Medicine
- Investigators
- Harvey Levin, PhD, Principal investigator, Baylor College of MedicineSteven Rao, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012463
- Sponsor's protocol ID
- PT074924P1
- Other IDs
- PT074924P1, H-22852
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2015
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Behavioral Sequelae of Blast-Related Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04012463
- Acronym / sponsor ID
- PT074924P1
- Conditions
- TBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Jul 2019 (actual)
- 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.
Hypothesis 1: On fMRI scanning, frontoparietal activation during performance of executive function tasks of working memory, inhibitory control processes, and stimulus-response interference will exhibit greater signal intensity, a wider spatial extent, and more bilateral activation in chronic MTBI than chronic OI participants.
Hypothesis 2: DTI changes, characterized by lower FA and higher MD at the gray-white junction, corpus callosum, central semiovale, and internal capsule, will be seen in MTBI but not in OI subjects.
Hypothesis 3: Increased fMRI activation in chronic MTBI will be correlated with location and severity of disrupted fiber tracks that subserve neural networks associated with each fMRI activation task.
Hypothesis 4: Performance on computerized neuropsychological testing (ANAM) and reaction time measures on fMRI tasks will better discriminate MTBI from OI than standard paper-and pencil tests.
Hypothesis 5: The combination of fMRI, DTI, and ANAM will better discriminate MTBI from OI than each individual method.
Hypothesis 6: More severe brain pathology in MTBI, as measured by neuroimaging (fMRI, DTI) and ANAM test scores, will be associated with less severe PTSD and symptoms.
Detailed description
Traumatic brain injuries (TBI) are a common occurrence from roadside blasts of improvised explosive devices (IEDs). Like civilian TBI, blast-related TBI can result from mechanical forces in which objects in motion strike the head or the head is forcefully put into motion and strikes an object. TBI from exposure to an explosive blast may also result from a third cause: barotrauma. Blasts produce wave-induced changes in atmospheric pressure, which in turn produce characteristic injuries to vulnerable bodily regions at air-fluid interfaces, such as the middle ear. It is unknown whether the neural and cognitive sequelae of blast-related TBI differ from those resulting from mechanically-induced TBI commonly observed in civilian accidents. Understanding the potentially unique sequelae of blast-related TBI is critical for accurate diagnosis and designing effective pharamacological and neurorehabilitation interventions.
In the proposed cross-sectional study, we aim to apply neurobehavioral testing and advanced MRI techniques [task-activated functional MRI (fMRI) and diffusion tensor imaging (DTI)] to gain a comprehensive understanding of the neural changes underlying blast-related MTBI. This will be accomplished by comparing neurobehavioral and neuroimaging findings obtained from military personnel who have experienced a blast injury with those obtained from civilians who have experienced TBI from motor vehicle accidents and from military and civilian control participants with orthopedic injuries. We will accomplish this goal by conducting advanced neuroimaging (task-activated fMRI and DTI fiber tracking) and neurobehavioral testing (computerized assessment and standard neuropsychological testing) on 120 chronic trauma patients: 30 military MTBI patients who have experienced blast injuries, 30 civilian MTBI patients with mechanical closed head injuries, and 30 military and 30 civilian patients with orthopedic injuries.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a prospective, observational study using a cross-sectional design to compare brain imaging and neuropsychological findings at 12 to 72 months post-injury in four groups of at least 30 patients each: two groups of military patients who have sustained mild to moderate TBI (milMTBI) or orthopedic injury or uninjured veterans, reservists, or service members (milControl) and two groups of civilian patients who had MTBI (civMTBI) or OI (civOI).
Key inclusion criteria (3 listed)
- 1. GCS score 9-15 (if available) 2. Brain injury due to blast 3. Current age 18-45 4. Right-handed 5. Post-injury interval 12-72 months 6. Duration of Loss of Consciousness (LOC) < 24 hours 7. Duration of Posttraumatic Amnesia (PTA)< 7 days 8. No intracranial surgery 9. No brain lesions on computer tomography (CT) scan (if available) 10. Extracranial Injuries by Abbreviated Injury Scale (AIS) <3 (non-head)
- 1. GCS score 9-15 (if available) 2. Non-blast brain injury 3. Current age 18-45 4. Right-handed 5. Post-injury interval 12-72 months 6. LOC < 24 hours 7. PTA< 7 days 8. No intracranial surgery 9. No brain lesions on CT scan (if available) 10. Extracranial Injuries by AIS <3 (non-head)
- 1. No history of brain injury 2. Non-blast extracranial injury or no injury 3. Current age 18-45 4. Right-handed 5. Post-injury interval 12-72 months 6. LOC -none 7. PTA- none 8. No intracranial surgery 9. CT scan normal (if done) 10. Extracranial Injuries by AIS <3 (non-head)
Key exclusion criteria (1 listed)
- 1) Not fluent in English 2) Non-right hande 3) AIS score equal or higher 4 for body parts other than head 4) Neurologic deficit other than TBI (MTBI, OI groups); no LOC or PTA (MTBI groups) 5) Blood alcohol level > 200 mg/dL 6) Previous hospitalization for head injury 7) Pregnancy when screened prior to brain imaging 8) Pre-existing neurologic disorder associated with cerebral dysfunction and/or cognitive deficit (e.g., cerebral palsy, mental retardation, epilepsy) or diagnosed dyslexia 9) Pre-existing severe psychiatric disorder (bipolar disorder, schizophrenia) as determined by the Structured Clinical Interview for Depression 10) Penetrating gunshot wound to the brain 11) Contraindications to undergoing MRI, including implant of metal or marked agitation observed by research assistant. 12) Illegal alien 13) Hypoxia for 30 minutes or longer after resuscitation PO2 < 96 mmHg 14) Hypotension for 30 minutes or longer after resuscitation (systolic blood pressure more than 2SDs below mean for age)
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
Brain activation on Stop Signal Reaction Time Task (SSRT)
Time frame: 12-24 months post-injury
fMRI measuring brain activation associated with performance of SSRT
Brain activation on Sternberg Item Recognition Task (SIRT)
Time frame: 12-24 months post-injury
fMRI measuring brain activation associated with performance of SIRT
7 secondary outcomes
Neurobehavioral Symptom Inventory
Time frame: 12-24 months post-injury
Post-traumatic Symptom Checklist-Civilian (PCL-C)
Time frame: 12-24 months post-injury
Center for the Epidemiological Center for Study of Depression (CES-D)
Time frame: 12-24 months post-injury
Symbol Digit Modalities Test (SDMT)
Time frame: 12-24 months post-injury
Trail Making Test A and B
Time frame: 12-24 months post-injury
Controlled Oral Word Association
Time frame: 12-24 months post-injury
California Verbal Learning Test 2
Time frame: 12-24 months post-injury
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 9 Jul 2019.
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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.
Harvey Levin, PhD principal investigator
Baylor College of Medicine
Steven Rao, PhD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of TBI, run by Baylor College of Medicine.
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 3 inclusion and 1 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Brain activation on Stop Signal Reaction Time Task (SSRT) (time frame: 12-24 months post-injury). 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 9 Jul 2019.