Clinical trial NCT02957461: Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
Official title: Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Concussion, Mild
Concussion, Brain
Concussion, Severe
Concussion, Intermediate
Keywords: Concussion
Mild Traumatic Brain Injury
Sport Related Concussion
Lead sponsor: BrainScope Company, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2016-11-06
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 220 male and female student-athletes from participating universities or colleges will be invited to participate.

Brief summary: This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 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 NCT03671083 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.

Eligibility criteria: Inclusion Criteria (For Injured Subjects):

1. Time of injury within 72 hours of BrainScope Battery
2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
3. No hospital admission due to either head injury or collateral injuries for \>24 hours
4. GCS between 13-15

Exclusion Criteria:

1. Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
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. Do not speak or read English
7. Loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only
8. Prior history of concussion in the last year - for Matched Control subjects only

Primary outcomes:
measure: Likelihood of being concussed
timeFrame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary outcomes:
measure: Significance of change over time
timeFrame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
measure: Prediction of prolonged recovery
timeFrame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: University of Texas - Austin
state: Texas
Study officials:
affiliation: BrainScope Company, Inc.
name: Leslie Prichep, Ph.D.
role: STUDY_DIRECTOR
References: