Objective Brain Function Assessment of mTBI/Concussion

NCT03963804 | Completed FDA Device

• 1 other identifier: 31-Ahead
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Concussion; Mild Traumatic Brain Injury; Sport Related Concussion; Non-Sport Related Concussion

Outcome Measures

Primary Outcomes (1)

• Derivation of algorithm for Likelihood of being concussed using multimodal inputs

  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)

  6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP

Study Arms (2)

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.

Device: BrainScope Ahead 300iP

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.

Device: BrainScope Ahead 300iP

Interventions

BrainScope Ahead 300iP 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; Injured and Matched Control Subject Pool

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 490 Injured, Matched Control and Healthy Volunteer subjects will be recruited from high schools, college universities, concussion clinics and emergency rooms.

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.

Sponsors & Collaborators

• BrainScope Company, Inc.: lead

Study Sites (4)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 32228157 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Leslie Prichep, Ph.D.

  BrainScope Company, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 28, 2019
• Study Start: June 11, 2018
• Primary Completion: January 25, 2019
• Study Completion: March 29, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

US (4)