Neural and Behavioral Sequelae of Blast-Related Traumatic Brain Injury

NCT04012463 | Completed

• 2 other identifiers: PT074924P1H-22852
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

TBI

Outcome Measures

Primary Outcomes (2)

• Brain activation on Stop Signal Reaction Time Task (SSRT)

  fMRI measuring brain activation associated with performance of SSRT

  12-24 months post-injury

• Brain activation on Sternberg Item Recognition Task (SIRT)

  fMRI measuring brain activation associated with performance of SIRT

  12-24 months post-injury

Secondary Outcomes (7)

• Neurobehavioral Symptom Inventory

  12-24 months post-injury

• Post-traumatic Symptom Checklist-Civilian (PCL-C)

  12-24 months post-injury

• Center for the Epidemiological Center for Study of Depression (CES-D)

  12-24 months post-injury

• Symbol Digit Modalities Test (SDMT)

  12-24 months post-injury

• Trail Making Test A and B

  12-24 months post-injury

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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).

You may qualify if:

• \. 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)
• \. 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)
• \. 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)

You may not qualify if:

• \) 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)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Cleveland Clinic: collaborator

Study Officials

• Harvey Levin, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Steven Rao, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: July 9, 2019
• Study Start: June 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 9, 2019

Record last verified: 2015-03