Objective Brain Function Assessment of mTBI/Concussion

Completed

• Conditions: Concussion, Mild; Concussion, Brain; Concussion, Intermediate; Concussion, Severe; Brain Injuries, Traumatic
• Interventions: Device: BrainScope Ahead 300iP

• Registration Number: NCT03963804
• Lead Sponsor: BrainScope Company, Inc.

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.

Study Timeline

• Study Start: 2018-06-11
• Primary Completion: 2019-01-25
• Study Completion: 2019-03-29
• Status Verified: 2019-05
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-28
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

For Injured subjects:

1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
2. GCS 13-15 at time of BrainScope assessment;
3. No hospital admission due to either head injury or collateral injuries for >24 hours.

For Matched Controls:

1. GCS 15 at time of BrainScope assessment;
2. No prior history of concussion or TBI in the last year.

Exclusion Criteria

1. Previously enrolled in the BrainScope CAS Studies;
2. 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);
3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
4. History of brain surgery or neurological disease;
5. Pregnant women;
6. 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);
7. Acute intoxication;
8. Evidence of illicit drug usage;

For Injured subjects:

1. Loss of consciousness ≥ 20 minutes related to the concussion injury;
2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
3. 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:

1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer Subject Pool	BrainScope Ahead 300iP	This subject pool will consist of uninjured (not head injured) subjects and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects.
Injured and Matched Control Subject Pool	BrainScope Ahead 300iP	Injured subjects consist of subjects who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, ocular motor assessment, and clinical symptoms/assessments.

Primary Outcome Measures

Name	Time	Method
Derivation of algorithm for Likelihood of being concussed using multimodal inputs	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)

Trial Locations

Locations (4)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

University of Miami; 🇺🇸 Miami, Florida, United States