Investigating exercise effects on recovery from mild traumatic brain injury
The Exercise and Concussion Health Study (TECHS)
NA · Northeastern University · NCT06494592
This study is testing whether balance or aerobic exercises can help adults recover better from mild traumatic brain injuries by improving brain function and cognitive skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Northeastern University (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06494592 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of two different physical exercise interventions—balance and aerobic exercises—on brain function, cognition, and patient-reported outcomes in adults who have experienced a mild traumatic brain injury (mTBI). Participants will engage in three 30-minute remote exercise sessions each week for 12 weeks, supervised by trained professionals. The study aims to provide evidence-based management strategies for mTBI recovery, utilizing MRI and EEG assessments to measure brain activity and cognitive improvements. By comparing the two exercise types, the research seeks to identify the most effective approach for enhancing recovery post-injury.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 who have suffered a clinically diagnosed mild traumatic brain injury within the past year.
Not a fit: Patients who do not have a confirmed diagnosis of mTBI or those outside the age range of 18-55 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for patients with mild traumatic brain injuries, enhancing cognitive and brain health.
How similar studies have performed: While there is limited high-quality evidence on exercise interventions for mTBI, this approach is novel and aims to fill a significant gap in current treatment protocols.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Northeastern University — Boston, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Concussion, Mild, Concussion, Brain, TBI, Brain, Concussion