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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03837795
Enrollment
10
Registered
2019-02-12
Start date
2019-05-01
Completion date
2020-10-15
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory Modulation Disorder, Sensory Over-Responsivity

Keywords

Neurofeedback, Sensory Modulation Disorder, Sensory Over-Responsivity

Brief summary

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

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.

Interventions

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).

Sponsors

Tel Aviv University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

The researcher that will perform the measurement assessments will differ from the one that will provide the therapy sessions.

Intervention model description

it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness Questionnaire-Aversive scale. 2. free of analgesic medicines for no less than 24 hours before the sessions. 3. independent functioning in the community. 4. fluency in understanding and reading Hebrew

Exclusion criteria

1. metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis 2. acute or chronic pain. 3. regular intake of neurological, psychiatric and analgesic medicines. 4. participating in other therapies (i.e., cognitive therapies) at present. 5. substance abuse. 6. pregnancy.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
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 treatmenta standardized self-report questionnaire assessing daily pain sensitivity
Electroencephalogram (EEG) Resting State3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatmentTo measure alpha band (8-12Hz) power

Other

MeasureTime frameDescription
Auditory Evoked Related Potentials (AERP)3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatmentChange from Baseline to 28 days after the last treatment session: An EEG method will be used to evaluate the brain responses to auditory stimulus.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026