NCT03671083

Validation of Brain Function Assessment Algorithm for mTBI/Concussion

Validation of Brain Function Assessment Algorthm for mTBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 309 (actual)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 13 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	BrainScope Ahead 300iP	The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment, Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-03-01
• Completion: 2019-03-29
• First posted: 2018-09-14
• Last updated: 2019-05-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study