NCT03963804

Objective Brain Function Assessment of mTBI/Concussion

Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation in Concussion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 268 (actual)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 13 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This study (Part 3) 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.

Detailed description

Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. 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. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Conditions

• Brain Injuries, Traumatic
• Concussion, Mild
• Concussion, Intermediate
• Concussion, Severe
• 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 and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-01-25
• Completion: 2019-03-29
• First posted: 2019-05-28
• Last updated: 2019-05-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study