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NCT03963804 · ClinicalTrials.gov registry record
Objective Brain Function Assessment of mTBI/Concussion
A clinical trial of Brain Injuries, Traumatic and Concussion, Brain, sponsored by BrainScope Company.
- Completed
- Registry status
- 268
- Enrollment target
- 4
- Study locations
NCT03963804: Completed study of Brain Injuries, Traumatic and Concussion, Brain, sponsored by BrainScope Company.
NCT03963804 is a study of Brain Injuries, Traumatic and Concussion, Brain that has completed, run by BrainScope Company. The registered enrollment target is 268 participants, above the 243-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (10% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03963804, a study of Brain Injuries, Traumatic and Concussion, Brain, has completed, sponsored by BrainScope Company.
- COMPLETED
- Registry status
- 268 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination)
Conditions Studied
Interventions
- DEVICE BrainScope Ahead 300iP
Study Locations (4)
Arkansas
- University of Arkansas - Fayetteville
Florida
- University of Miami - Miami
Michigan
- Michigan State University - East Lansing
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2018-06-11 |
| Est. Completion | 2019-03-29 |
What the finished NCT03963804 record still lists
NCT03963804 is an observational study that tracks outcomes without assigning an intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, above the 243-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (10% higher).
The record links to 5 conditions, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 1 intervention - of which BrainScope Ahead 300iP is the first listed.
NCT03963804 reports a single indexed study location in Arkansas, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT03963804 about?
NCT03963804 is a clinical study titled "Objective Brain Function Assessment of mTBI/Concussion". 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.
What is the current status of trial NCT03963804?
This trial is currently completed. The enrollment target is 268 participants. The study started on 2018-06-11. Estimated completion is 2019-03-29.
What conditions does trial NCT03963804 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic, Concussion, Brain, Concussion, Mild, Concussion, Intermediate, Concussion, Severe.
What interventions are being tested in trial NCT03963804?
The interventions under investigation include: BrainScope Ahead 300iP (DEVICE).
Who is sponsoring clinical trial NCT03963804?
This trial is sponsored by BrainScope Company, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03963804 being conducted?
This trial has 4 study locations across Arkansas, Florida, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03963804's enrollment target sits among peer trials
268 7th of 21 higher than 15 of 21 other Brain Injuries, Traumatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Injuries, Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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