Status:
ACTIVE_NOT_RECRUITING
Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)
Lead Sponsor:
Carey Balaban
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
University of Miami
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study will establish the capability of a suite of conventional tests and the Neurolign Dx\_100 I-PAS goggle system to reliably and objectively detect mTBI in an acute setting when comparing indiv...
Detailed Description
The investigators will employ a comprehensive assessment battery to include vestibular/oculomotor, cognitive, and symptom domains using measures that are consistent with the NIH/NINDS common data elem...
Eligibility Criteria
Inclusion
- For the mTBI group, participants must present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following criteria:
- clear mechanism of injury (i.e., direct or indirect impact to head),
- Glasgow Coma Scale= 13-15, 3) observed or reported signs (e.g., loss of consciousness, amnesia, or confusion) or symptoms (e.g., headache, dizziness, nausea), and
- neurosensory symptoms.
- For Control group, participants will have minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mTBI will be recruited from the same study sites.
Exclusion
- History of moderate to severe TBI characterized by any of the following:
- Penetrating head trauma
- GCS\< 13 at the time of injury
- Associated with LOC \> 30 minutes or amnesia \>24 hours
- Associated with subdural or epidural hemorrhage
- mTBI history
- mTBI Group - history of mTBI within the last 6 months or experiencing head injury symptoms immediately prior to the current head injury or history of 3 or more mTBIs
- Controls - No history of mTBI within the last 12 months and no presence of any mTBI-related symptoms at time of enrollment
- Presence of severe aphasia
- History of diagnosed psychiatric disorder (e.g., schizophrenia)
- Documented neurological disorders (e.g., Epilepsy, stroke, dementia)
- Pregnancy (females will be asked if they are pregnant)
- Prior disorders of hearing and balance including:
- Meniere's disease
- Multiple sclerosis
- Vestibular neuritis
- Vestibular schwannoma
- Sudden sensorineural hearing loss
- History of tumor of the brain or central nervous system
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04372797
Start Date
September 30 2020
End Date
November 30 2025
Last Update
January 6 2025
Active Locations (3)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134
2
University of Miami
Miami, Florida, United States, 33136
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203