Mild Traumatic Brain Injury
Conditions
Keywords
mild Traumatic Brain Injury, mTBI, Concussion
Brief summary
The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.
Interventions
None listed
Sponsors
ElMindA Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 13-18 years * Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments * Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
Exclusion criteria
* Current or history of TBI (i.e., Glasgow Coma Scale \<13) or brain surgery * Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder * Substance abuse within the last year * Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder * Current or history of any Neurological disorder, e.g., epilepsy, seizures * History of any medication affecting CNS within the last year, e.g., antidepressants, anticonvulsants, Ritalin, first generation antihistamines, etc. * Current or history of Significant sensory deficits such as deafness or blindness * Current or history of Clinically significant abnormal laboratory values or ECG * A concussion within the last year * Current or history of residual symptoms or deficits related to a previous concussion * Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning Autism, PDD * Currently with lice or open wounds on scalp * Long and thick hair that prevents the proper administration of an EEG cap
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | To examine prospectively changes in brain network activation (BNA) from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | To investigate the relationship between changes in BNA to changes in symptoms from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. |
| Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | To investigate the relationship between changes in BNA to changes in cognitive performance from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. |
| Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period | baseline, 1-7, 8-14, and 15-21 day post-injury intervals | To investigate the relationship between changes in BNA to changes in vestibular function from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion. |
Countries
United States
Outcome results
None listed