Status:
COMPLETED
Neural and Behavioral Sequelae of Blast-Related Traumatic Brain Injury
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
TBI
Eligibility:
All Genders
18-45 years
Brief 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 exhibi...
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 obje...
Eligibility Criteria
Inclusion
- Inclusion Criteria for milMTBI
- 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)
- Inclusion Criteria for civlMTBI
- 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)
- Inclusion Criteria for milControl and civOI
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04012463
Start Date
June 1 2012
End Date
May 1 2014
Last Update
July 9 2019
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