Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation in Concussion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries, Traumatic
- Sponsor
- BrainScope Company, Inc.
- Enrollment
- 268
- Locations
- 4
- Primary Endpoint
- Derivation of algorithm for Likelihood of being concussed using multimodal inputs
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.
Detailed Description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Injured subjects:
- •Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
- •GCS 13-15 at time of BrainScope assessment;
- •No hospital admission due to either head injury or collateral injuries for \>24 hours.
- •For Matched Controls:
- •GCS 15 at time of BrainScope assessment;
- •No prior history of concussion or TBI in the last year.
Exclusion Criteria
- •Previously enrolled in the BrainScope CAS Studies;
- •Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
- •Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
- •History of brain surgery or neurological disease;
- •Pregnant women;
- •Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
- •Acute intoxication;
- •Evidence of illicit drug usage;
- •For Injured subjects:
- •Loss of consciousness ≥ 20 minutes related to the concussion injury;
Outcomes
Primary Outcomes
Derivation of algorithm for Likelihood of being concussed using multimodal inputs
Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination)