The Efficiency of Neurofeedback Therapy for Enhancing Participation in Occupations, Decreasing Pain Sensitivity, Improving Life Satisfaction and Brain Neural Activity in Adults With Sensory Over Responsivity - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
研究概览
简要总结
Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory stimuli and can significantly impact pain perception and restrict daily participation and quality of life. Altered neurophysiological processes in SOR are documented, revealing reduced electroencephalogram at rest and P300 amplitudes, the latter tested through event-related potentials (ERP). Both may explain the failure to regulate incoming sensory stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes.
Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction and Goal Attainment Scaling (GAS) scores in adults with SOR.
详细描述
In this serial experimental research design, 10 individuals with SOR aged 21-45 years will participate. A medical and demographic questionnaire and the Sensory Responsiveness Questionnaire-Intensity Scale (SRQ-IS) will be applied to screen for participation eligibility. Outcome measures will be conducted at 4-time points (1. baseline- 3 weeks pre-treatment; 2. before the first treatment session; 3. after the last treatment session; and 4. a month post-treatment) applying: The Goal Attainment Scaling (GAS), the P300 component using a neurophysiological assessment of the 'Oddball paradigm', the alpha power using electroencephalogram resting state, and electronic versions of the Satisfaction with Life Scale, the World Health Organization Disability Assessment Schedule, and the Pain Sensitivity Questionnaire. Sixteen individually therapy sessions of 45 minutes each, twice a week, will be held at the same time of day.
Repeated measures ANOVA or a non-parametric equivalent will be used to analyze the dependent variables measures change over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The researcher that will perform the measurement assessments will differ from the one that will provide the therapy sessions.
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness Questionnaire-Aversive scale.
- •free of analgesic medicines for no less than 24 hours before the sessions.
- •independent functioning in the community.
- •fluency in understanding and reading Hebrew
排除标准
- •metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis
- •acute or chronic pain.
- •regular intake of neurological, psychiatric and analgesic medicines.
- •participating in other therapies (i.e., cognitive therapies) at present.
- •substance abuse.
结局指标
主要结局
The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
时间窗: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
To evaluate participants' participation level in the last month
The Satisfaction with Life Scale (SWLS)
时间窗: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
assesses global life satisfaction
Goal Attainment Scaling (GAS)
时间窗: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
a standardized therapeutic method used to evaluate the participants' progress toward their functional goals
次要结局
- Pain Sensitivity Questionnaire (PSQ)(3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment)
- Electroencephalogram (EEG) Resting State(3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment)
研究者
Tami Bar-Shalita
Principal Investigator
Tel Aviv University