The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms
NCT ID: NCT03338036
Last Updated: 2022-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2018-01-01
2018-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
Non-Concussed Control Group
Age-matched individuals who have not been diagnosed with a concussion in the previous two years
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Previously suffered a clinically diagnosed concussion
2. Participated in, completed, and have been discharged from the BrainEx90 outpatient concussion rehabilitation program at Parkwood Institute
3. Continued post-concussive symptoms
4. 18 years of age or older
5. Access to transportation
6. Capable of utilizing hand-held technology (ie. cell phone, tablet, etc.)
7. Holds a valid Driver's License
8. English speaking
Participants in the non-concussed control arm:
1. 18 years of age or older
2. Holds a valid driver's license
3. English speaking
4. Has not suffered a concussion in the last two years
Exclusion Criteria
1. Any heart disease, pacemaker, abnormal heartbeat patterns, coronary artery disease, or bypass surgery
2. Any mental health disorder that would interfere with participation in the study
3. Under 18 years of age
4. Unable to provide written informed consent or complete questionnaires due to language or cognitive difficulties
5. Inability to operate a motor vehicle
6. 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
18 Years
ALL
No
Sponsors
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Parkwood Hospital, London, Ontario
OTHER
Western University, Canada
OTHER
Responsible Party
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James Dickey
Sponsor-Investigator
Principal Investigators
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James P Dickey, PhD
Role: PRINCIPAL_INVESTIGATOR
Western University
Locations
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University of Western Ontario
London, Ontario, Canada
Countries
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References
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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.
Conder 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.
Heart 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.
Fisk 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.
Gevensleben 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.
Ingebrigtsen 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.
Lagos, 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.
Milleville-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.
Munivenkatappa 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.
Preece 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.
Thompson, 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
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Western University REB 109760
Identifier Type: -
Identifier Source: org_study_id
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