Trials / Completed
CompletedNCT02957461
Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 420 (actual)
- Sponsor
- BrainScope Company, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 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 NCT03671083 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, Brain
- Concussion, Severe
- Concussion, Intermediate
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BrainScope Ahead 200iD | The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG. |
Timeline
- Start date
- 2017-02-03
- Primary completion
- 2018-01-31
- Completion
- 2018-03-02
- First posted
- 2016-11-07
- Last updated
- 2019-05-23
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02957461. Inclusion in this directory is not an endorsement.