Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT06819904
Eligibility Criteria:
Inclusion Criteria:
* 18-49 years of age
* Normal/corrected vision
* Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional.
* Reported or observed signs of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting at the time of injury as determined by self-report.
* Positive for mTBI-related vestibular symptoms and/or impairments per a concussion common data elements (CDE) assessment. Participants must demonstrate a positive finding in at least one of the following tests: DVAT (\>2 lines lost), DNRS (\>2/10 score), VVAS (\>0 on 2 or more items), VOMS (\>2 score on VOR or VMS), mBESS (\> 9 total errors), and CP-Screen (avg vestibular factor score \>/= 2 or single item = 3 severity)
Exclusion Criteria:
* History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report and/or by Physical Therapist exam.
* Exercise-induced dizziness as determined by the Physical Therapist exam.
* History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.
* Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.
* Previous moderate to severe TBI as determined by self-report.
* \< 8 days following current mTBI as determined by self-report.
* Currently pregnant as determined by self-report.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT06819904
Study Brief:
Protocol Section:
NCT06819904