Objective Brain Function Assessment of mTBI/Concussion

Completed

Conditions studied: Brain Injuries, Traumatic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe, Concussion, Brain

In brief

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.

Key facts

Study ID

NCT03963804

Run by

BrainScope Company, Inc.

People needed

268

Starts

2018-06-11

Expected to finish

2019-03-29

Last updated by the study team

2019-05-28

Who can join

Age: 13 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
• Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment).
• For Matched Controls:
• Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
• History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.

Where it is running

• University of Arkansas — Fayetteville, Arkansas, United States
• University of Miami — Miami, Florida, United States
• Michigan State University — East Lansing, Michigan, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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