Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)
Completed · Not applicable
Conditions studied: Mild Traumatic Brain Injury
In brief
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 individuals with mTBI to controls with minor injuries in a similarly stressful environment.
Key facts
- Study ID
- NCT04372797
- Run by
- Carey Balaban
- People needed
- 161
- Starts
- 2020-09-30
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Naval Medical Center San Diego — San Diego, California, United States
- University of Miami — Miami, Florida, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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