Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04074486
Study type Observational
Source BrainScope Company, Inc.
Contact
Status Completed
Phase
Start date October 2, 2019
Completion date March 31, 2022

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03400904 - Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
Completed NCT06073145 - Transcranial Doppler Using Wearable Ultrasound Patch
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Recruiting NCT06010823 - Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants N/A
Not yet recruiting NCT05833568 - Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness N/A
Withdrawn NCT04288076 - The Brain and Lung Interaction (BALI) Study N/A
Completed NCT03162484 - Physical Activity and Chronic Acquired Brain Injury N/A
Not yet recruiting NCT02756585 - Computed Tomography Perfusion in Patients With Severe Head Injury N/A
Terminated NCT01430988 - Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury N/A
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A
Completed NCT00975338 - The LETS Study: A Longitudinal Evaluation of Transition Services
Completed NCT00878631 - Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline Phase 2/Phase 3
Completed NCT03166722 - Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition N/A
Not yet recruiting NCT04478812 - Tbit System Precision and Correlation of Different Blood Samples N/A
Recruiting NCT05309005 - Virtual Reality and Social Cognition After Acquired Brain Injury
Recruiting NCT05443542 - VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI N/A
Completed NCT02702635 - Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging N/A
Withdrawn NCT04247321 - Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure N/A
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4