Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sensory Modulation Disorder, Sensory Over-Responsivity

Intervention / Treatment
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* Device: Neurofeedback treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. pregnancy.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback therapy group<br> | Device: Neurofeedback treatment<br>* A treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Satisfaction with Life Scale (SWLS) | assesses global life satisfaction | assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session | 
| Goal Attainment Scaling (GAS) | a standardized therapeutic method used to evaluate the participants' progress toward their functional goals | assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session | 
| The World Health Organization Disability Assessment Schedule (WHODAS-2.0) | To evaluate participants' participation level in the last month | assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Sensitivity Questionnaire (PSQ) | a standardized self-report questionnaire assessing daily pain sensitivity | 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 | To measure alpha band (8-12Hz) power | 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback, Sensory Modulation Disorder, Sensory Over-Responsivity