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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04549532
Eligibility Criteria:
Inclusion Criteria: Participants must meet ALL of the following inclusion criteria:
* 18-49 years of age
* Normal/corrected vision
* Diagnosed with complex mTBI in the past 8 days-6 months with clear mechanism of injury
* Glascow coma scale (GCS) score no less than 13
* Reported or sign of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting
* Complex mTBI-related symptoms and/or impairments in at least one of the following areas: anxiety/mood, cognitive, migraine, ocular, vestibular, sleep, autonomic; per a comprehensive assessment, clinical exam/interview, and adjudication process.
Exclusion Criteria: Participants will be excluded if they meet one or more of the following exclusion criteria:
* History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral, or bilateral vestibular hypofunction)
* History of neurological disorder
* Previous moderate to severe TBI
* History of brain surgery, malformations or tumors
* Diagnosed with cardiac, peripheral or cerebrovascular disease
* Experienced chest pain or shortness of breath while at rest or with mild exertion
* Been told by a doctor to only conduct physical activity under medical supervision
* Previous moderate to severe TBI
* \< 8 days or \>6 months following current complex mTBI
* Currently pregnant or become pregnant during study
* Currently involved in litigation associated with current or previous mTBI
* Currently on workman's compensation
* Previously participated in the study
* Previously received treatment at either site within last two years as this will unblind treatment group(s)
* Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.
* Please note that participants with a history of mTBI, ADHD/LD, migraine, or motion sickness will NOT be excluded. We will adjust for any imbalance in the groups on these factors via covariate analysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT04549532
Study Brief:
Protocol Section:
NCT04549532