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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04074486
Other study ID # 55/60
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2, 2019
Est. completion date March 31, 2022

Study information

Verified date June 2022
Source BrainScope Company, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).


Description:

Phase 1 of this project (USAMRDC W81XWH-18-C-0157) was focused on building the automated/electronic NPC capability (eNPC). This protocol is for Phase 2, in which the CI multimodal brain function biomarker will be extended (Algorithm Development) with the inclusion of an automated ocular function measurement (AOFM), to expand the capability in the characterization of concussion. The study will also expand the range of applicability of the CI to ages 13-50 years old. Phase 2 will also include norming of eNPC across the age range. Phase 3 of the project will validate the algorithms developed in Phase 2, using the same protocol.


Recruitment information / eligibility

Status Completed
Enrollment 1318
Est. completion date March 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 50 Years
Eligibility Inclusion Criteria: - Age =13 and <51 years old at time of enrollment; - No prior history of concussion or TBI in the last 6 months. For head injured subjects - Having sustained a traumatic closed head injury within 120 hours (5 days from time of injury at time of BrainScope assessment); - GCS 13-15 at time of BrainScope assessment. For non-concussed head-injured controls - Having sustained a traumatic closed head injury but returned to play or deemed non-concussed following sideline (on-field) evaluation within the same game and enrolled in the study within 120 hours (5 days) from said incident. - GCS 13-15 at time of BrainScope assessment. For matched controls and healthy volunteers • GCS 15 at time of BrainScope assessment. Exclusion Criteria: - Enrolled in any previous BrainScope clinical study; - Current CNS active prescription medications taken daily, except for medication being taken for the treatment of Attention Deficit Disorders (ADD/ADHD); medication for smoking cessation; or medications for anxiety taken PRN (as needed); - Forehead, scalp or skull abnormalities that prevents headset application for EEG data collection in injured/matched controls; - History of brain tumor, brain surgery or known neurological disease including, Parkinson's, MS, Alzheimer's, dementia, epilepsy; - History of TIA or Stroke within the last year; - 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 abuse in the last year; - Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment; - Subjects currently receiving dialysis or have end-stage renal disease; - Subjects requiring advanced airway management (i.e. mechanical ventilation); - Prisoners. For head injured subjects - Loss of consciousness = 20 minutes related to the concussion injury; - Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (note: neuroimaging is not required for enrollment); - For current injury, hospital admission (other than the Observation Unit) ranging more than 24 hours due to either head injury or collateral injuries. For non-concussed head-injured controls - Loss of consciousness = 20 minutes related to the head impact; - Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech; - Any score >3 on a 7-point Likert scale (0=none, 6=severe) for the following symptoms at the time of BrainScope assessment (compared to how the subject normally feels): headache, dizziness, balance problems, neck pain, feeling slowed down; For matched controls and healthy volunteers - Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech; - Hospital admission (other than the Observation Unit) ranging more than 24 hours due to either head injury or collateral injuries in the past 6 months; - Any score >3 on a 7-point Likert scale (0=none, 6=severe) for the following symptoms at the time of BrainScope assessment (compared to how the subject normally feels): headache, dizziness, balance problems, neck pain, feeling slowed down. For healthy volunteers - Legally blind in one or both eyes; - History of eye surgery in the past year; - Any known eye disorders including age-related macular degeneration (AMD), glaucoma, lazy eye, diplopia, cataracts, etc.

Study Design


Intervention

Device:
BrainScope Ahead 300iP-O
BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.
Diagnostic Test:
SCAT5
Sports Concussion Assessment Tool 5
Near Point Convergence
Manual ocular function measurement conducted only if electronic version on device fails

Locations

Country Name City State
United States Michigan State University East Lansing Michigan
United States INOVA Health System Fairfax Virginia
United States University of Arkansas Fayetteville Arkansas
United States University of Miami Miami Florida
United States University of Rochester Medical Center Rochester New York
United States University of Connecticut Storrs Connecticut

Sponsors (2)

Lead Sponsor Collaborator
BrainScope Company, Inc. United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of the multivariate and multimodal Concussion Index Sensitivity and specificity of the expanded CI for assessment of the likelihood of concussion in subjects ages 13-50 who sustained a closed head injury. 18 months for data acquisition
Secondary Efficacy of use The demonstration of efficacy of use of this biomarker of brain function impairment/concussion to assess readiness to return to normal activity 18 months for data acquisition
Secondary Identification of concussion subtypes Validation of subtypes (at time of injury) with different clinical characterizations and outcome (e.g., rapid versus prolonged recovery). 18 months for data acquisition
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