Trials / Completed
CompletedNCT02661633
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in High School Athletes
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 177 (actual)
- Sponsor
- BrainScope Company, Inc. · Industry
- Sex
- All
- Age
- 13 Years – 19 Years
- Healthy volunteers
- Not accepted
Summary
This study (Part 2) 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. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).
Detailed description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
Conditions
- Brain Injuries, Traumatic
- Concussion, Brain
- Concussion, Mild
- Concussion, Intermediate
- Concussion, Severe
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 a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG. |
| DEVICE | Advanced MRI Neuroimaging | Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image. |
Timeline
- Start date
- 2016-01-29
- Primary completion
- 2017-01-31
- Completion
- 2017-07-31
- First posted
- 2016-01-22
- Last updated
- 2019-05-23
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02661633. Inclusion in this directory is not an endorsement.