Ignite Creation Date:
2025-12-18 @ 9:28 AM
Ignite Modification Date:
2025-12-18 @ 9:28 AM
Study NCT ID:
NCT01963247
Status:
None
Last Update Posted:
2015-04-09 00:00:00
First Post:
2013-10-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth Athletes
Status:
None
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single center study evaluating the effectiveness of BNA technology as an objective tool for sport related concussion management in youth athletes' populations.
The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled in this study will undergo a screening and baseline pre season visit and follow up visit/s.
1. Follow-up testing for concussed athletes - Concussed athletes will complete a series of post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam by neurologist or neurology nurse practitioner. The first visit will be within 72 hours of injury and re-evaluations will occur weekly until BNA has normalized AND subject is asymptomatic. Subject may return to play at that point and subject will have a final additional BNA™ test one week after the athlete returns to full activity. If participant is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2 weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to baseline at three months, monthly reevaluations until study completion.
2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a follow up visit upon completion of the sport season.
The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled in this study will undergo a screening and baseline pre season visit and follow up visit/s.
1. Follow-up testing for concussed athletes - Concussed athletes will complete a series of post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam by neurologist or neurology nurse practitioner. The first visit will be within 72 hours of injury and re-evaluations will occur weekly until BNA has normalized AND subject is asymptomatic. Subject may return to play at that point and subject will have a final additional BNA™ test one week after the athlete returns to full activity. If participant is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2 weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to baseline at three months, monthly reevaluations until study completion.
2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a follow up visit upon completion of the sport season.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: