Mild Traumatic Brain Injury
Conditions
Keywords
mild Traumatic Brain Injury, mTBI, Concussion
Brief summary
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment. This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.
Interventions
None listed
Sponsors
ElMindA Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
Phase 1: Inclusion Criteria: * Aged 14-26 years * Enrolled in a recognized high school or college * Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self) * Currently participate in a non-contact sport. * Member of an organized athletic team or regularly train for and participate in independent athletic contests during at least one sports season. * Right handed subject
Exclusion criteria
* Currently participate in a contact sport. * Bald or has dread locks/long and thick hair. * Any diagnosed psychiatric disorder * History of CNS injury or disease * Any neuropsychological disorders * History of learning disability. * History of any medication affecting CNS. * Active head lice infection, open scalp wound, deafness or/and blindness. * Sustained a diagnosed concussion within the previous 6 months Phase 2a: Inclusion Criteria: * Aged 14-26 years. * For Arm 1: Within 1 week post-concussion (sports-related). * For Arm 1: Currently symptomatic * Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self). * Member of an organized athletic team or regularly train. * Enrolled in a high school or college.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Brain Network Activation(BNA™)Scores | P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season |
Secondary
| Measure | Time frame |
|---|---|
| Correlation Of The Change In BNA™ Scores To Clinical Diagnstic | P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season |
| Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes | P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season |
| Correlation Of The Change In BNA™ Scores To Reaction Time Scores | P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season |
Countries
United States
Outcome results
None listed