Trial Outcomes & Findings for The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms (NCT NCT03338036)
NCT ID: NCT03338036
Last Updated: 2022-08-09
Results Overview
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.)
COMPLETED
NA
31 participants
baseline and post-intervention (8 weeks)
2022-08-09
Participant Flow
Participant milestones
| Measure |
Heart Rate Variability Biofeedback
Participants in this arm of the study will only receive HRV biofeedback. This 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. Participants in this arm will meet with the co-investigator bi-weekly to review progress and express feedback.
Heart Rate Variability Biofeedback: 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.
|
Heart Rate Variability/Neurofeedback
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
Post-Concussed Control Group
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
11
|
12
|
8
|
|
Overall Study
COMPLETED
|
0
|
7
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Heart Rate Variability Biofeedback
Participants in this arm of the study will only receive HRV biofeedback. This 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. Participants in this arm will meet with the co-investigator bi-weekly to review progress and express feedback.
Heart Rate Variability Biofeedback: 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.
|
Heart Rate Variability/Neurofeedback
n=7 Participants
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
Post-Concussed Control Group
n=9 Participants
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
n=8 Participants
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
48.6 years
STANDARD_DEVIATION 13 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 7.6 • n=9 Participants
|
50.1 years
STANDARD_DEVIATION 15.5 • n=8 Participants
|
51.21 years
STANDARD_DEVIATION 12.15 • n=24 Participants
|
|
Sex: Female, Male
Female
|
—
|
4 Participants
n=7 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
—
|
3 Participants
n=7 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
—
|
7 participants
n=7 Participants
|
9 participants
n=9 Participants
|
8 participants
n=8 Participants
|
24 participants
n=24 Participants
|
|
RPQ
|
—
|
19.43 units on a scale
STANDARD_DEVIATION 14.11 • n=7 Participants
|
20.67 units on a scale
STANDARD_DEVIATION 13.63 • n=9 Participants
|
2.06 units on a scale
STANDARD_DEVIATION 4.19 • n=8 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 9.99 • n=24 Participants
|
|
GAD
|
—
|
10.89 units on a scale
STANDARD_DEVIATION 4.91 • n=7 Participants
|
8.89 units on a scale
STANDARD_DEVIATION 5.37 • n=9 Participants
|
3.43 units on a scale
STANDARD_DEVIATION 3.55 • n=8 Participants
|
7.65 units on a scale
STANDARD_DEVIATION 4.57 • n=24 Participants
|
|
SDNN
|
—
|
43.86 ms
STANDARD_DEVIATION 14.11 • n=7 Participants
|
42.89 ms
STANDARD_DEVIATION 16.6 • n=9 Participants
|
46.29 ms
STANDARD_DEVIATION 23.57 • n=8 Participants
|
44.306 ms
STANDARD_DEVIATION 17.99 • n=24 Participants
|
|
EEG
|
—
|
.4 Hz
STANDARD_DEVIATION .95 • n=7 Participants
|
.07 Hz
STANDARD_DEVIATION .43 • n=9 Participants
|
.5 Hz
STANDARD_DEVIATION .82 • n=8 Participants
|
.31 Hz
STANDARD_DEVIATION .67 • n=24 Participants
|
PRIMARY outcome
Timeframe: 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.)
Outcome measures
| Measure |
Post-Concussed Control Group
n=9 Participants
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
n=8 Participants
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
Heart Rate Variability/Neurofeedback
n=7 Participants
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
|---|---|---|---|
|
Change In SDNN
|
21.87 ms
Standard Deviation 4.67
|
19.4 ms
Standard Deviation 4.4
|
43. ms
Standard Deviation 12.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Post-Concussed Control Group
n=9 Participants
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
n=8 Participants
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
Heart Rate Variability/Neurofeedback
n=7 Participants
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
|---|---|---|---|
|
Number of Participants Making Driving Simulator Mistakes
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Post-Concussed Control Group
n=9 Participants
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
n=8 Participants
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
Heart Rate Variability/Neurofeedback
n=7 Participants
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
|---|---|---|---|
|
Change In Electrocardiograph Amplitudes
|
.33 Z-score
Standard Deviation .79
|
.87 Z-score
Standard Deviation 1.01
|
-.23 Z-score
Standard Deviation .64
|
SECONDARY outcome
Timeframe: 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 severe problem (worse outcome). Scores range from 0-72, where 72 represents experiencing all symptoms, and they are all a severe problem (worse outcome).
Outcome measures
| Measure |
Post-Concussed Control Group
n=9 Participants
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
n=8 Participants
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
Heart Rate Variability/Neurofeedback
n=7 Participants
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
|---|---|---|---|
|
Change In Number and Severity of Post-concussive Symptoms
|
20.56 units on a scale
Standard Deviation 14.56
|
1.5 units on a scale
Standard Deviation 3.69
|
18.36 units on a scale
Standard Deviation 14.24
|
SECONDARY outcome
Timeframe: 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 outcome).
Outcome measures
| Measure |
Post-Concussed Control Group
n=9 Participants
Age-matched, previously concussed individuals that have completed the same concussion rehabilitation program (Brain Ex 90) will be recruited for this arm.
|
Non-Concussed Control Group
n=8 Participants
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
|
Heart Rate Variability/Neurofeedback
n=7 Participants
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.
Heart Rate Variability Biofeedback: 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.
Neurofeedback: LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
|
|---|---|---|---|
|
Change In Anxiety
|
8.33 units on a scale
Standard Deviation 6.04
|
2 units on a scale
Standard Deviation 1.63
|
8.56 units on a scale
Standard Deviation 5.13
|
Adverse Events
Heart Rate Variability/Neurofeedback
Post-Concussed Control Group
Non-Concussed Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Jim Dickey, Associate Professor
University of Western Ontario
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place