Status:
COMPLETED
The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
Parkwood Hospital, London, Ontario
Conditions:
Post-Concussion Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Most concussions resolve within 7-10 days, but approximately 40% of individuals do not fully recover and suffer from persistent post-concussive symptoms. This 8-week intervention study will evaluate t...
Detailed Description
40% of minor head injuries are diagnosed with post-concussion syndrome 3 months after injury (Ingebrigtsen, Waterloo, Marup-Jensen, Attner, \& Romner, 1998). These individuals have persistent symptoms...
Eligibility Criteria
Inclusion
- Participants in HRV and the HRV/Neurofeedback intervention arms, and the post-concussion control arm:
- Previously suffered a clinically diagnosed concussion
- Participated in, completed, and have been discharged from the BrainEx90 outpatient concussion rehabilitation program at Parkwood Institute
- Continued post-concussive symptoms
- 18 years of age or older
- Access to transportation
- Capable of utilizing hand-held technology (ie. cell phone, tablet, etc.)
- Holds a valid Driver's License
- English speaking
- Participants in the non-concussed control arm:
- 18 years of age or older
- Holds a valid driver's license
- English speaking
- Has not suffered a concussion in the last two years
Exclusion
- All participants:
- Any heart disease, pacemaker, abnormal heartbeat patterns, coronary artery disease, or bypass surgery
- Any mental health disorder that would interfere with participation in the study
- Under 18 years of age
- Unable to provide written informed consent or complete questionnaires due to language or cognitive difficulties
- Inability to operate a motor vehicle
- Inability to look at a digital screen for 30 minutes
- Participants in the non-concussed control arm:
- 1\. Suffered a concussion in the last two years
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03338036
Start Date
January 1 2018
End Date
August 31 2018
Last Update
August 9 2022
Active Locations (1)
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1
University of Western Ontario
London, Ontario, Canada, N6A3K7