NCT03338036

The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms

Completed NA Results posted Last updated 9 August 2022

What this trial tests

NA trial testing Heart Rate Variability Biofeedback in Post-Concussion Syndrome in 31 participants. Completed in 31 August 2018.

Timeline

1 January 2018

Primary endpoint
31 August 2018

31 August 2018

Quick facts

Lead sponsor	Western University, Canada
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	1 January 2018
Primary completion	31 August 2018
Estimated completion	31 August 2018
Sites	1 location across Canada

Drugs / interventions tested

• Heart Rate Variability Biofeedback — full drug profile →
• Neurofeedback

Conditions studied

• Post-Concussion Syndrome — all drugs for Post-Concussion Syndrome →

Sponsor

Western University, Canada

Who can join

18 and older, any sex, with Post-Concussion Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change In SDNN Primary · baseline and post-intervention (8 weeks)

The interval between heartbeats, specifically the artifact-free intervals between R waves in the QRS complex, will be measured. This is known as the standard deviation of the norm (SDNN), and is a universal method of quantifying HRV (Camm et al., 1996). This information is collected using the Mindja application for android devices, created by Evoke Neuroscience.The physiologically relevant norms are a mean of 50 (SD 16) and a range from 32-93 ms (Shaffer F, Ginsberg JP. An Overview of Heart Rate variability Metrics and Norms. Frontiers in Public Health. 2017 Sep;5(258):1.)

Group	Value	95% CI
Heart Rate Variability/Neurofeedback	43.	± 12.1
Post-Concussed Control Group	21.87	± 4.67
Non-Concussed Control Group	19.4	± 4.4

Number of Participants Making Driving Simulator Mistakes Primary · baseline and post-intervention (8 weeks)

Participants will perform a driving simulation task using the DriveSafety CDS-250 driving simulator. It will record the performance, and afterwards a trained rater will review and evaluate the number of driving errors using a standardized assessment form. The number of individuals that made a driving simulator mistake are reported. The minimum is zero and the maximum is the number of participants in the Arm/Group. We are not aware of any physiologically relevant ranges for this measure.

Group	Value	95% CI
Heart Rate Variability/Neurofeedback	0
Post-Concussed Control Group	2
Non-Concussed Control Group	0

Change In Electrocardiograph Amplitudes Primary · baseline and post-intervention (8 weeks)

The amplitude and power of alpha, beta, theta, and delta frequencies will be evaluated relative to reference norms (Gevensleben et al., 2010) and expressed as Z-scores (deviation from the mean divided by the standard deviation). In terms of physiologically relevant norms, 99% of the population will have scores between -3 and +3. This information is collected and stored in a secured cloud between Evoke Neuroscience and Western University.

Group	Value	95% CI
Heart Rate Variability/Neurofeedback	-.23	± .64
Post-Concussed Control Group	.33	± .79
Non-Concussed Control Group	.87	± 1.01

Change In Number and Severity of Post-concussive Symptoms Secondary · baseline and post-intervention (8 weeks)

These are assessed using the Rivermead Post Concussion Questionnaire (RPQ). It evaluates the severity of 16 common post-concussion symptoms over the past 24 hours (with the option to add 2 additional symptoms not already listed). Some examples include headache, sleep disturbance, noise sensitivity and blurred vision. It asks the evaluator to compare each symptom to how they would "normally" have felt prior to the concussion. It is a 5-point scale, which goes from 0-4. When the symptom is not experienced at all, the evaluator is to put a 0 (better outcome), whereas 4 indicates the symptom is a

Group	Value	95% CI
Heart Rate Variability/Neurofeedback	18.36	± 14.24
Post-Concussed Control Group	20.56	± 14.56
Non-Concussed Control Group	1.5	± 3.69

Change In Anxiety Secondary · baseline and post-intervention (8 weeks)

This is assessed using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). Seven anxiety symptoms experienced over the past 2 weeks are evaluated on a 4-point scale, which goes from 0-3. Some examples include feeling nervous or anxious, inability to stop worrying, and trouble relaxing. When the symptom is not experienced at all, the evaluator is to put a 0 (better outcome), whereas 3 indicates the symptom is experienced nearly every day (worse outcome). Score totals range from 0 to 21, where 21 represents experiencing all symptoms, and they are all experienced nearly every day (worse outcom

Group	Value	95% CI
Heart Rate Variability/Neurofeedback	8.56	± 5.13
Post-Concussed Control Group	8.33	± 6.04
Non-Concussed Control Group	2	± 1.63

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.