Validation of Brain Function Assessment Algorithm for mTBI/Concussion

Completed

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

In brief

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

Key facts

Study ID

NCT03671083

Run by

BrainScope Company, Inc.

People needed

309

Starts

2018-10-01

Expected to finish

2019-03-29

Last updated by the study team

2019-05-23

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
• Washington University — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.