Concussion Clinical Trial
Official title:
A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
NCT number | NCT02660164 |
Other study ID # | JMC-1501 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | March 2019 |
Verified date | June 2022 |
Source | Jan Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.
Status | Completed |
Enrollment | 149 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. Male or female subjects between 10 and 25 years of age (middle school, high school or college-age) 2. Team member, where the team meets at least twice a week 3. Willing and able to participate in all study evaluations and allow access to medical testing and records 4. Signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor Exclusion Criteria: 1. Documented history of a concussion diagnosed by a physician in the last two months assessed via interview with athlete 2. Known history of any cognitive deficits that diminish ability to administer study assessments, such as SCAT3™ 3. Wound on the head in the area of one of the Nautilus BrainPulse sensors that would impede use of the Nautilus BrainPulse device 4. Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion 5. Any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation |
Country | Name | City | State |
---|---|---|---|
United States | Louisiana State University | Baton Rouge | Louisiana |
United States | Meli Orthopedic Centers of Excellence | Fort Lauderdale | Florida |
United States | University of Wyoming | Laramie | Wyoming |
United States | Community Hospital | Munster | Indiana |
Lead Sponsor | Collaborator |
---|---|
Jan Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and Specificity of the Nautilus Brain Pulse in detecting concussion as compared to adjudication by a panel of medical experts | Sensitivity and Specificity of the Nautilus BrainPulse in detecting the number of subjects experiencing concussion as compared to the number of subjects with concussion as adjudicated by a panel of medical experts. BrainPulse measurement data will be aggregated by subject over the first 10-days of recording after the concussive event, or for subjects in the Control arm, after their selection as a control subject. | 10 days |
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