An interventional study of Neurofeedback treatment in Sensory Modulation Disorder and Sensory Over-Responsivity, sponsored by Tel Aviv University. Completed at 1 site in Israel. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment
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.
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.
Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.
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Device: Neurofeedback treatment
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).
The Satisfaction with Life Scale (SWLS)
assesses global life satisfaction
Time frame: 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
Time frame: 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
Time frame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
Pain Sensitivity Questionnaire (PSQ)
a standardized self-report questionnaire assessing daily pain sensitivity
Time frame: 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
Time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
Auditory Evoked Related Potentials (AERP)
Change from Baseline to 28 days after the last treatment session: An EEG method will be used to evaluate the brain responses to auditory stimulus.
Time frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Tel Aviv University