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Clinical Trials/NCT03837795
NCT03837795
Completed
Not Applicable

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

Tel Aviv University1 site in 1 country10 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensory Modulation Disorder
Sponsor
Tel Aviv University
Enrollment
10
Locations
1
Primary Endpoint
The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tami Bar-Shalita

Principal Investigator

Tel Aviv University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The World Health Organization Disability Assessment Schedule (WHODAS-2.0)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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