Post-Concussion SyndromeNCT03338036
The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms
A study testing Heart Rate Variability Biofeedback and Neurofeedback in people with Post-Concussion Syndrome, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Heart Rate Variability Biofeedback and Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Inability to look at a digital screen for 30 minutes
- Participants in the non-concussed control arm:
- 1. Suffered a concussion in the last two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Neurofeedback and Heart Rate Variability Biofeedback for Individuals With Long-term Post-concussive Symptoms
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.
Read the detailed description
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.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Heart Rate Variability Biofeedback, Neurofeedback
- Keywords
- Concussion, Post-Concussion Syndrome, Biofeedback, Heart Rate Variability, Neurofeedback
- Medical subject headings
- Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability BiofeedbackDevice
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.
NeurofeedbackDevice
LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
| Study group | Role | What they receive |
|---|---|---|
| Heart Rate Variability/Neurofeedback | Experimental | 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. Receives: Device: Heart Rate Variability Biofeedback; Device: Neurofeedback |
| Post-Concussed Control Group | No intervention | 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 | No intervention | Age-matched individuals who have not been diagnosed with a concussion in the previous two years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 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.
Measured: baseline and post-intervention (8 weeks)
Secondary outcomes (2)
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).
Measured: 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).
Measured: baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will include two intervention arms and two control arms. The intervention arms will include 1) heart rate variability biofeedback, 2) a combination of heart rate variability biofeedback and neurofeedback. The control arms will be 1) age-matched post-concussive individuals and 2) age-matched individuals who have not been diagnosed with a concussion in the last two years.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Parkwood Hospital, London, Ontario
- Responsible party
- Principal investigator, James Dickey, Western University, Canada
- Investigators
- James P Dickey, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338036
- Sponsor's protocol ID
- Western University REB 109760
- Status last verified
- Jul 2022
- First submitted
- 3 Nov 2017
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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).
Publications
Bivona U, D'Ippolito M, Giustini M, Vignally P, Longo E, Taggi F, Formisano R. Return to driving after severe traumatic brain injury: increased risk of traffic accidents and personal responsibility. J Head Trauma Rehabil. 2012 May-Jun;27(3):210-5. doi: 10.1097/HTR.0b013e31822178a9.
PubMed 21829135Conder RL, Conder AA. Heart rate variability interventions for concussion and rehabilitation. Front Psychol. 2014 Aug 13;5:890. doi: 10.3389/fpsyg.2014.00890. eCollection 2014.
PubMed 25165461Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Fisk GD, Schneider JJ, Novack TA. Driving following traumatic brain injury: prevalence, exposure, advice and evaluations. Brain Inj. 1998 Aug;12(8):683-95. doi: 10.1080/026990598122241.
PubMed 9724839Gevensleben H, Holl B, Albrecht B, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Neurofeedback training in children with ADHD: 6-month follow-up of a randomised controlled trial. Eur Child Adolesc Psychiatry. 2010 Sep;19(9):715-24. doi: 10.1007/s00787-010-0109-5. Epub 2010 May 25.
PubMed 20499120Ingebrigtsen T, Waterloo K, Marup-Jensen S, Attner E, Romner B. Quantification of post-concussion symptoms 3 months after minor head injury in 100 consecutive patients. J Neurol. 1998 Sep;245(9):609-12. doi: 10.1007/s004150050254.
PubMed 9758300Lagos, L., Bottiglieri, T., Vaschillo, B., & Vaschillo, E. (2012). Heart Rate Variability Biofeedback for Postconcussion Syndrome: Implications for Treatment. Biofeedback, 40(4), 150-153. doi:10.5298/1081-5937-40.4.05
Lagos, L., Thompson, J., & Vaschillo, E. (2013). A Preliminary Study: Heart Rate Variability Biofeedback for Treatment of Postconcussion Syndrome. Biofeedback, 41(3), 136-143. doi:10.5298/1081-5937-41.3.02
Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
PubMed 25101026Milleville-Pennel I, Pothier J, Hoc JM, Mathe JF. Consequences of cognitive impairments following traumatic brain injury: Pilot study on visual exploration while driving. Brain Inj. 2010;24(4):678-91. doi: 10.3109/02699051003692159.
PubMed 20235770Munivenkatappa A, Rajeswaran J, Indira Devi B, Bennet N, Upadhyay N. EEG Neurofeedback therapy: Can it attenuate brain changes in TBI? NeuroRehabilitation. 2014;35(3):481-4. doi: 10.3233/NRE-141140.
PubMed 25238859Preece MH, Horswill MS, Geffen GM. Driving after concussion: the acute effect of mild traumatic brain injury on drivers' hazard perception. Neuropsychology. 2010 Jul;24(4):493-503. doi: 10.1037/a0018903.
PubMed 20604623Thompson, M., Thompson, L., Reid-Chung, A., & Thompson, J. (2013). Managing Traumatic Brain Injury: Appropriate Assessment and a Rationale for Using Neurofeedback and Biofeedback to Enhance Recovery in Postconcussion Syndrome. Biofeedback, 41(4), 158-173. doi:10.5298/1081-5937-41.4.07
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neurofeedback and Heart Rate Variability Biofeedback for Individuals With Long-term Post-concussive Symptoms
- ClinicalTrials.gov ID
- NCT03338036
- Acronym / sponsor ID
- Western University REB 109760
- Conditions
- Post-Concussion Syndrome
- Keywords
- Concussion, Post-Concussion Syndrome, Biofeedback, Heart Rate Variability, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Parkwood Hospital, London, Ontario
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will include two intervention arms and two control arms. The intervention arms will include 1) heart rate variability biofeedback, 2) a combination of heart rate variability biofeedback and neurofeedback. The control arms will be 1) age-matched post-concussive individuals and 2) age-matched individuals who have not been diagnosed with a concussion in the last two years.
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Variability/Neurofeedback | Experimental | Device: Heart Rate Variability Biofeedback, Device: NeurofeedbackParticipants 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. |
| Post-Concussed Control Group | No intervention | –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 | No intervention | –Age-matched individuals who have not been diagnosed with a concussion in the previous two years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate Variability BiofeedbackHRV 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. | Device | Heart Rate Variability/Neurofeedback |
| NeurofeedbackLORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator. | Device | Heart Rate Variability/Neurofeedback |
Primary outcome
Change In SDNN
Time frame: 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.)
Number of Participants Making Driving Simulator Mistakes
Time frame: 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.
Change In Electrocardiograph Amplitudes
Time frame: 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.
2 secondary outcomes
Change In Number and Severity of Post-concussive Symptoms
Time frame: baseline and post-intervention (8 weeks)
Change In Anxiety
Time frame: baseline and post-intervention (8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21829135Bivona U, D'Ippolito M, Giustini M, Vignally P, Longo E, Taggi F, Formisano R. Return to driving after severe traumatic brain injury: increased risk of traffic accidents and personal responsibility. J Head Trauma Rehabil. 2012 May-Jun;27(3):210-5. doi: 10.1097/HTR.0b013e31822178a9.
- Background: PubMed 25165461Conder RL, Conder AA. Heart rate variability interventions for concussion and rehabilitation. Front Psychol. 2014 Aug 13;5:890. doi: 10.3389/fpsyg.2014.00890. eCollection 2014.
- Background: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Background: PubMed 9724839Fisk GD, Schneider JJ, Novack TA. Driving following traumatic brain injury: prevalence, exposure, advice and evaluations. Brain Inj. 1998 Aug;12(8):683-95. doi: 10.1080/026990598122241.
- Background: PubMed 20499120Gevensleben H, Holl B, Albrecht B, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Neurofeedback training in children with ADHD: 6-month follow-up of a randomised controlled trial. Eur Child Adolesc Psychiatry. 2010 Sep;19(9):715-24. doi: 10.1007/s00787-010-0109-5. Epub 2010 May 25.
- Background: PubMed 9758300Ingebrigtsen T, Waterloo K, Marup-Jensen S, Attner E, Romner B. Quantification of post-concussion symptoms 3 months after minor head injury in 100 consecutive patients. J Neurol. 1998 Sep;245(9):609-12. doi: 10.1007/s004150050254.
- BackgroundLagos, L., Bottiglieri, T., Vaschillo, B., & Vaschillo, E. (2012). Heart Rate Variability Biofeedback for Postconcussion Syndrome: Implications for Treatment. Biofeedback, 40(4), 150-153. doi:10.5298/1081-5937-40.4.05
- BackgroundLagos, L., Thompson, J., & Vaschillo, E. (2013). A Preliminary Study: Heart Rate Variability Biofeedback for Treatment of Postconcussion Syndrome. Biofeedback, 41(3), 136-143. doi:10.5298/1081-5937-41.3.02
- Background: PubMed 25101026Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
- Background: PubMed 20235770Milleville-Pennel I, Pothier J, Hoc JM, Mathe JF. Consequences of cognitive impairments following traumatic brain injury: Pilot study on visual exploration while driving. Brain Inj. 2010;24(4):678-91. doi: 10.3109/02699051003692159.
- Background: PubMed 25238859Munivenkatappa A, Rajeswaran J, Indira Devi B, Bennet N, Upadhyay N. EEG Neurofeedback therapy: Can it attenuate brain changes in TBI? NeuroRehabilitation. 2014;35(3):481-4. doi: 10.3233/NRE-141140.
- Background: PubMed 20604623Preece MH, Horswill MS, Geffen GM. Driving after concussion: the acute effect of mild traumatic brain injury on drivers' hazard perception. Neuropsychology. 2010 Jul;24(4):493-503. doi: 10.1037/a0018903.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P Dickey, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability Biofeedback and Neurofeedback in people with Post-Concussion Syndrome, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In SDNN (time frame: baseline and post-intervention (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03338036, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.