Validation of Brain Function Assessment Algorithm for mTBI/Concussion

NCT03671083 | Completed FDA Device

• 1 other identifier: 52-Ahead
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Likelihood of being concussed

  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)

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

Secondary Outcomes (2)

• Significance of change over time

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

• Prediction of prolonged recovery

  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, 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 160 Injured and Matched Control 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 (5)

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

Washington University

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

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: August 10, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 29, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

US (5)