N/A
Completed N=31
The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms
Post-Concussion Syndrome
Source: ClinicalTrials.gov NCT03338036 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Change In SDNN — 43.; 21.87; 19.4 ms
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.
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 | — |
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. Informational only — not medical advice.