Brain Injuries, Traumatic Clinical Trial
— CAS13-25VOfficial title:
Validation of Brain Function Assessment Algorthm for mTBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics
NCT number | NCT03671083 |
Other study ID # | 52-Ahead |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | March 29, 2019 |
Verified date | May 2019 |
Source | BrainScope Company, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.
Status | Completed |
Enrollment | 309 |
Est. completion date | March 29, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 25 Years |
Eligibility |
Inclusion Criteria: For Injured subjects: 1. Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment; 2. GCS 13-15 at time of BrainScope assessment; 3. No hospital admission due to either head injury or collateral injuries for >24 hours. For Matched Controls: 1. GCS 15 at time of BrainScope assessment; 2. No prior history of concussion or TBI in the last year. Exclusion Criteria: 1. Previously enrolled in the BrainScope CAS Studies; 2. Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD); 3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection; 4. History of brain surgery or neurological disease; 5. Pregnant women; 6. Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available); 7. Acute intoxication; 8. Evidence of illicit drug usage; For Injured subjects: 1. Loss of consciousness = 20 minutes related to the concussion injury; 2. Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment; 3. Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment). For Matched Controls: 1. Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech; 2. History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year. |
Country | Name | City | State |
---|---|---|---|
United States | Michigan State University | East Lansing | Michigan |
United States | University of Arkansas | Fayetteville | Arkansas |
United States | University of Miami | Miami | Florida |
United States | University of Rochester | Rochester | New York |
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
BrainScope Company, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Likelihood of being concussed | Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI) | 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP | |
Secondary | Significance of change over time | Significant difference in concussion index between time of injury and return to play (RTP) | 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP | |
Secondary | Prediction of prolonged recovery | Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index | 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP |
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