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临床试验/NCT03338036
NCT03338036已完成不适用

The Effectiveness of Neurofeedback and Heart Rate Variability Biofeedback for Individuals With Long-term Post-concussive Symptoms

Western University, Canada2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Change In SDNN

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • 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
  • Inability to look at a digital screen for 30 minutes
  • Participants in the non-concussed control arm:
  • Suffered a concussion in the last two years

结局指标

主要结局

Change In SDNN

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Change In Number and Severity of Post-concussive Symptoms(baseline and post-intervention (8 weeks))
  • Change In Anxiety(baseline and post-intervention (8 weeks))

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

James Dickey

Sponsor-Investigator

Western University, Canada

研究点 (2)

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