An interventional study of Heart Rate Variability Biofeedback and Neurofeedback in Post-Concussion Syndrome, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment
Among 30 studies in Post-Concussion Syndrome with a site in Canada — 3 open to participants now, 5 under way, none of them phase 3. Post-Concussion Syndrome · Canada.
Among the 30 studies in Post-Concussion Syndrome with a site in Canada, this one is the 17th largest by enrollment, is one of 4 that started in 2018, is one of 26 with no phase, and was the 12th registered.
140 studies on the registry are indexed under Post-Concussion Syndrome; 33 are open to participants now.
Browse Post-Concussion Syndrome studies →3 of the 30 studies in Post-Concussion Syndrome with a site in Canada are open now. Recruiting first, the newest first:
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18–60
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18–60
Michael Zitney · Sites in Canada
Ages 18–70 · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 24 Post-Concussion Syndrome studies recruiting now, 3 (13%) set no upper age limit and 20 (83%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 1
First in 2004; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 31 is below the median of 52 across 113 interventional studies indexed under Post-Concussion Syndrome.
Median enrollment 40 across the 30 interventional studies. Of the 14 that completed or were terminated, 1 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 30 have an industry lead sponsor. The 10 most frequent:
Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
Western University, Canada has 3 studies filed under Post-Concussion Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Post-Concussion Syndrome with a site in Canada, from their registry updates:
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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.
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 after completing conventional rehabilitation programs. Persistent post-concussion symptoms not only decrease quality of life (Ingebrigtsen et al, 1998), but also impair cognitive and motor performance and increase the likelihood of impaired driving performance (Preece, Horswill, \& Geffen, 2010) and motor vehicle accidents (Bivona et al, 2012). While case reports indicate that biofeedback can reduce the number and severity of post-concussive symptoms (Lagos, Thompson, \& Vaschillo, 2013; Thompson, Thompson, Reid-Chung, \& Thompson, 2013), no studies have systematically evaluated these biofeedback treatment programs.
HRV biofeedback works by displaying beat-to-beat heart rate data to the participant, and through operant conditioning with breathing techniques, the participant learns to control their HRV (Lehrer \& Gevirtz, 2014). This results in an increase in parasympathetic (PNS) activity and decrease in sympathetic (SNS) activity, which leads to reduced anxiety, and increased focus and concentration (Lagos, Bottiglieri, Vaschillo, \& Vaschillo, 2012). Neurofeedback works in a similar fashion, except it monitors brain wave power, frequency, and connectivity using quantitative electroencephalogram (EEG). Brain functioning is displayed while playing an electronic game, and the participant learns through operant conditioning to increase the amplitude of desired EEG frequencies, such as low beta waves that are associated with active problem solving, usually while simultaneously decreasing the amplitudes of undesired EEG frequencies (Conder \& Conder, 2014).
This will be an eight-week intervention where participants suffering from long-term post-concussion symptoms will be recruited using email from the cohort of individuals that have been discharged after completing a concussion rehabilitation protocol (BrainEx90) at Parkwood Institute in London, Ontario. Non-concussed control participants will be recruited using posters. Participants will complete pre, mid, and post-intervention driving simulation tasks, electrocardiogram and HRV measures, and subjective questionnaires. These will be utilized to evaluate the effectiveness of HRV biofeedback and neurofeedback in this difficult to treat population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants in HRV and the HRV/Neurofeedback intervention arms, and the post-concussion control arm:
Participants in the non-concussed control arm:
Exclusion Criteria:
All participants:
Participants in the non-concussed control arm:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm of the study will receive HRV biofeedback and neurofeedback. HRV biofeedback will occur twice daily, using an android device and application. Additionally, three times per week they will have one-hour long neurofeedback sessions.
Device: Heart Rate Variability Biofeedback · Device: Neurofeedback
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.
LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
Change In SDNN
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.)
Time frame: baseline and post-intervention (8 weeks)
Number of Participants Making Driving Simulator Mistakes
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.
Time frame: baseline and post-intervention (8 weeks)
Change In Electrocardiograph Amplitudes
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.
Time frame: baseline and post-intervention (8 weeks)
Change In Number and Severity of Post-concussive Symptoms
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 severe problem (worse outcome). Scores range from 0-72, where 72 represents experiencing all symptoms, and they are all a severe problem (worse outcome).
Time frame: baseline and post-intervention (8 weeks)
Change In Anxiety
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 outcome).
Time frame: baseline and post-intervention (8 weeks)
| Milestone | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group |
|---|---|---|---|---|
| Started | 0 | 11 | 12 | 8 |
| Completed | 0 | 7 | 9 | 8 |
| Not completed | 0 | 4 | 3 | 0 |
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.)
| ms | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group |
|---|---|---|---|
| Change In SDNN | 43. ± 12.1 | 21.87 ± 4.67 | 19.4 ± 4.4 |
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.
| Participants | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group |
|---|---|---|---|
| Number of Participants Making Driving Simulator Mistakes | 0 | 2 | 0 |
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.
| Z-score | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group |
|---|---|---|---|
| Change In Electrocardiograph Amplitudes | -.23 ± .64 | .33 ± .79 | .87 ± 1.01 |
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 severe problem (worse outcome). Scores range from 0-72, where 72 represents experiencing all symptoms, and they are all a severe problem (worse outcome).
| units on a scale | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group |
|---|---|---|---|
| Change In Number and Severity of Post-concussive Symptoms | 18.36 ± 14.24 | 20.56 ± 14.56 | 1.5 ± 3.69 |
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 outcome).
| units on a scale | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group |
|---|---|---|---|
| Change In Anxiety | 8.56 ± 5.13 | 8.33 ± 6.04 | 2 ± 1.63 |
Collected over during the 8 week intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Heart Rate Variability/Neurofeedback | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Post-Concussed Control Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Non-Concussed Control Group | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
Given our low recruitment rate, we abandoned one arm of the study; the Heart Rate Variability Biofeedback arm was abandoned.
| Age, Continuous(years) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Mean | — | 48.6 ± 13 | 54.6 ± 7.6 | 50.1 ± 15.5 | 51.21 ± 12.15 |
| Sex: Female, Male(Participants) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Female | — | 4 | 6 | 4 | 14 |
| Male | — | 3 | 3 | 4 | 10 |
| Race and Ethnicity Not Collected(Participants) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Canada | — | 7 | 9 | 8 | 24 |
| RPQ(units on a scale) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Mean | — | 19.43 ± 14.11 | 20.67 ± 13.63 | 2.06 ± 4.19 | 14.1 ± 9.99 |
| GAD(units on a scale) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Mean | — | 10.89 ± 4.91 | 8.89 ± 5.37 | 3.43 ± 3.55 | 7.65 ± 4.57 |
| SDNN(ms) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Mean | — | 43.86 ± 14.11 | 42.89 ± 16.6 | 46.29 ± 23.57 | 44.306 ± 17.99 |
| EEG(Hz) | Heart Rate Variability Biofeedback | Heart Rate Variability/Neurofeedback | Post-Concussed Control Group | Non-Concussed Control Group | Total |
|---|---|---|---|---|---|
| Mean | — | .4 ± .95 | .07 ± .43 | .5 ± .82 | .31 ± .67 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Each participant will be identified with a code (eg. PCS001) that correlates to his or her addition to the study. The master sheet will be the only document that contains the decoding system, and will be stored in a locked filing cabinet. All other data will be labeled using the participant's identification code. Neurophysiological data sent to Evoke Neuroscience will not contain any personal identifiers. Data sent between Evoke Neuroscience and Western University is sent in a secure file transfer. All other de-identified data stored on a Western University hard drive is within a secure university network (J drive).
Ran from Jan 2018 to primary completion in Aug 2018, 7 months.
Results were first posted in Jun 2020, 1 year 9 months after primary completion.
Of 54 non-industry interventional studies with no phase under Post-Concussion Syndrome, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's 7 months is below that.
Counting every sponsor, half of 56 studies reached it within 40 months; a quarter within 23 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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