Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes

Brain Injuries, Traumatic Clinical Trial

— CASVAL  

Official title:

Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957461
• Other study ID #: 18-Ahead
• Status: Completed
• Start date: February 3, 2017
• Est. completion date: March 2, 2018

Study information

• Verified date: August 2018
• Source: BrainScope Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: March 2, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• BrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.

Locations

Country	Name	City	State
United States	University of Texas - Austin	Austin	Texas
United States	University of South Carolina	Columbia	South Carolina
United States	Michigan State University	East Lansing	Michigan
United States	University of Arkansas	Fayetteville	Arkansas
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Connecticut	Storrs	Connecticut
United States	SUNY Upstate Medical University	Syracuse	New York
United States	University of South Florida	Tampa	Florida

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	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	Significance of change over time	Significant difference in concussion index between time of injury and return to play (RTP)	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary	Prediction of prolonged recovery	Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP