NCT04074486

Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,318 (actual)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 13 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).

Detailed description

Phase 1 of this project (USAMRDC W81XWH-18-C-0157) was focused on building the automated/electronic NPC capability (eNPC). This protocol is for Phase 2, in which the CI multimodal brain function biomarker will be extended (Algorithm Development) with the inclusion of an automated ocular function measurement (AOFM), to expand the capability in the characterization of concussion. The study will also expand the range of applicability of the CI to ages 13-50 years old. Phase 2 will also include norming of eNPC across the age range. Phase 3 of the project will validate the algorithms developed in Phase 2, using the same protocol.

Conditions

• Brain Injuries
• Concussion, Mild
• Concussion, Brain
• Near Point Convergence
• Concussion, Intermediate

Interventions

Type	Name	Description
DEVICE	BrainScope Ahead 300iP-O	BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.
DIAGNOSTIC_TEST	SCAT5	Sports Concussion Assessment Tool 5
DIAGNOSTIC_TEST	Near Point Convergence	Manual ocular function measurement conducted only if electronic version on device fails

Timeline

• Start date: 2019-10-02
• Primary completion: 2022-01-31
• Completion: 2022-03-31
• First posted: 2019-08-30
• Last updated: 2022-06-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study