Clinical trial NCT03671083: Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Official title: Validation of Brain Function Assessment Algorthm for mTBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: BrainScope Company, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 309
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

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: Miami
country: United States
facility: University of Miami
state: Florida
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: BrainScope Company, Inc.
name: Leslie Prichep, Ph.D.
role: STUDY_DIRECTOR
References: