N/A
N=31
The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms
Post-Concussion Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03338036 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change In SDNN — 43.; 21.87; 19.4 ms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heart Rate Variability Biofeedback (Device); Neurofeedback (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Western University, Canada
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change In SDNN |
43.; 21.87; 19.4 | — |
| PRIMARY Number of Participants Making Driving Simulator Mistakes |
0; 2; 0 | — |
| PRIMARY Change In Electrocardiograph Amplitudes |
-.23; .33; .87 | — |
| SECONDARY Change In Number and Severity of Post-concussive Symptoms |
18.36; 20.56; 1.5 | — |
| SECONDARY Change In Anxiety |
8.56; 8.33; 2 | — |
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 the efficacy of heart rate variability (HRV) biofeedback and neurofeedback on reducing the number and severity of concussion symptoms.
Eligibility Criteria
Inclusion Criteria
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 Criteria
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:
- Suffered a concussion in the last two years
Data sourced from ClinicalTrials.gov (NCT03338036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.