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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338036
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Parkwood Hospital, London, Ontario
Information provided by (Responsible Party):
James Dickey, Western University, Canada

Brief 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 concussion symptoms.

Condition or disease Intervention/treatment Phase
Post-Concussion Syndrome Device: Heart Rate Variability Biofeedback Device: Neurofeedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effectiveness of Neurofeedback and Heart Rate Variability Biofeedback for Individuals With Long-term Post-concussive Symptoms
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Device: Neurofeedback
LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.

No Intervention: 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 Intervention: Non-Concussed Control Group
Age-matched individuals who have not been diagnosed with a concussion in the previous two years



Primary Outcome Measures :
  1. 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.

  2. Change In Driving Simulation Errors [ 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.

  3. 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). This information is collected and stored in a secured cloud between Evoke Neuroscience and Western University.


Secondary Outcome Measures :
  1. Change In Number and Severity of Post-concussive Symptoms [ Time Frame: 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).

  2. Change In Anxiety [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants in HRV and the HRV/Neurofeedback intervention arms, and the post-concussion control arm:

  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:

All participants:

  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338036


Locations
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Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A3K7
Sponsors and Collaborators
Western University, Canada
Parkwood Hospital, London, Ontario
Investigators
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Principal Investigator: James P Dickey, PhD Western University
  Study Documents (Full-Text)

Documents provided by James Dickey, Western University, Canada:
Publications:
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
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

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Responsible Party: James Dickey, Sponsor-Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT03338036    
Other Study ID Numbers: Western University REB 109760
First Posted: November 9, 2017    Key Record Dates
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by James Dickey, Western University, Canada:
Concussion
Post-Concussion Syndrome
Biofeedback
Heart Rate Variability
Neurofeedback
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating