Objective Brain Function Assessment of mTBI/Concussion

NCT ID: NCT03963804

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 268 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-03-29

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.

Conditions

Brain Injuries, Traumatic; Concussion, Mild; Concussion, Intermediate; Concussion, Severe; Concussion, Brain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Injured and Matched Control Subject Pool

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.

BrainScope Ahead 300iP

Intervention Type: DEVICE

The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.

Healthy Volunteer Subject Pool

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.

BrainScope Ahead 300iP

Intervention Type: DEVICE

The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.

Interventions

BrainScope Ahead 300iP

The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BrainScope Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Prichep, Ph.D.

Role: STUDY_DIRECTOR

BrainScope Company, Inc.

Locations

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

Countries

United States

References

Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.

Reference Type: DERIVED

PMID: 32228157 (View on PubMed)

Other Identifiers

31-Ahead

Identifier Type: -

Identifier Source: org_study_id