Validation of Brain Function Assessment Algorithm for mTBI/Concussion

Completed

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

• Registration Number: NCT03671083
• Lead Sponsor: BrainScope Company, Inc.

Brief Summary

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.

Detailed Description

EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT02957461 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. 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.

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2018-10-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-29
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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
Likelihood of being concussed	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP	Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI)

Secondary Outcome Measures

Name	Time	Method
Significance of change over time	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP	Significant difference in concussion index between time of injury and return to play (RTP)
Prediction of prolonged recovery	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP	Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index

Trial Locations

Locations (5)

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

Washington University; 🇺🇸 Saint Louis, Missouri, United States

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

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

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