Clinical trial NCT02661633: Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
Official title: Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in High School Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Concussion, Brain
Concussion, Mild
Concussion, Intermediate
Concussion, Severe
Keywords: Concussion
Mild Traumatic Brain Injury
Sport Related Concussion
Lead sponsor: BrainScope Company, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 177
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 150 male and female student-athletes from participating high schools will be invited to participate.

Brief summary: This study (Part 2) 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. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

Detailed description: Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility criteria: Inclusion Criteria:

* Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.

  1. If loss of consciousness, total duration less than \<20 minutes
  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. Do not speak or read English
2. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
3. Skull abnormalities, e.g. metal plate
4. History of brain surgery or neurological disease
5. Pregnant women.

Primary outcomes:
measure: Algorithm for 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: Advanced Neuroimaging in concussion
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: Bethesda
country: United States
facility: Walt Whitman High School
state: Maryland
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: BrainScope Company, Inc.
name: Leslie Prichep, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.