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:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT06222502
Eligibility Criteria:
Inclusion Criteria:
• Suffered a mild or moderate traumatic brain injury within 3 months to 15 years prior to recruitment.
\* TBI history will be assessed using the validated OSU TBI history questionnaire (Attachment 1). TBI severity will be defined as loss of consciousness of 0-30 minutes (mild) or \>30 minutes and \<24 hours (moderate). If no loss of consciousness was reported but post-traumatic amnesia was reported, then this is considered a mild TBI.
If clinical reports from the time of injury are available and Glasgow Coma Scale scores are available, then 13-15 is considered mild and 9-12 moderate. A clinical neurologist will review the de-identified OSU TBI forms for accuracy and confirm TBI severity.
* Men and women of all ethnicities/races and socio-economic status.
* 40-80 years.
* Signed Informed consent.
* Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History \& Demographics Questionnaire. An affirmative response (i.e., \"yes\") to any single item regarding an individual's health status is grounds for the necessary medical clearance before enrollment.
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision).
* Able to speak, read, and write English.
* Ambulatory without pain or the assistance of walking devices.
* Reliable means of transportation (if participating in Boston).
* No diagnosis of a neurological disease.
* No intracerebral brain bleeds.
* Access to a mobile device, laptop or desktop computer with internet access and Bluetooth.
Exclusion Criteria:
* Diagnosis of a severe TBI (loss of consciousness \>24 hours, post-traumatic amnesia \> 7 days of a Glasgow Coma Scale of \<9) or the presentation of skull breach.
* Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
* Not fluent in English.
* Undergoing any speech or physical therapy
* Not medically cleared for exercise.
* No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant dizziness)
* History of intracerebral brain bleeds or strokes.
* Neurological condition (MS, Parkinson's, Dementia, MCI).
* Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events.
* Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year.
* Regular use of an assisted walking device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06222502
Study Brief:
Protocol Section:
NCT06222502