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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT06494592
Eligibility Criteria:
Inclusion Criteria:
* Suffered from a clinically diagnosed mild traumatic brain injury (concussion) within 1 year of injury.
\*All potential participants who do not have an official concussion diagnosis from a physician or were not recruited directly from Concussion and Brain Injury clinic at Beth Israel Deaconess Medical Center (BIDMC) will have a phone-based consultation with a trained neurologist from BIDMC to confirm a diagnosis of mTBI, (i.e. any loss of consciousness of up to 30 mins, any loss of memory for events immediately before or after the accident for as much as 24h, any alteration in mental state at the time of the accident and a Glasgow coma score of 13 to 15) (Marshall et al., 2012) per a reliance agreement between Beth Israel Deaconess medical center and northeastern university.
* Men and women of all ethnicities/races and socio-economic status.
* 18-55 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.
* No diagnosis of a neurological disease.
* MRI compatible.
* No brain bleeds.
Exclusion Criteria:
* Diagnosis of a moderate-to-severe TBI (Glasgow Coma Score of 3-12) or the presentation of skull breach and/or presence of known subdural hematoma.
* Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
* Not fluent in English.
* Not medically cleared for exercise.
* Not MRI compatible.
* No history of vasovagal episodes. (sudden drops in heart rate, poor perfusion, constant dizziness)
* History of brain bleeds or strokes.
* Neurological condition (MS, Parkinson's, Dementia, MCI).
* Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep-vein thrombosis or other cardiovascular events.
* Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac conditions in the past year.
* Regular use of an assisted walking device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06494592
Study Brief:
Protocol Section:
NCT06494592