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

Not Applicable

Completed

• Conditions: Sensory Modulation Disorder; Sensory Over-Responsivity
• Interventions: Device: Neurofeedback treatment

• Registration Number: NCT03837795
• Lead Sponsor: Tel Aviv University

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.

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-02-09
• Study First Posted: 2019-02-12
• Study Start: 2019-05-01
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurofeedback therapy group	Neurofeedback treatment	-

Primary Outcome Measures

Name	Time	Method
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 session	To evaluate participants' participation level in the last month
The Satisfaction with Life Scale (SWLS)	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)	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 Outcome Measures

Name	Time	Method
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	a standardized self-report questionnaire assessing daily pain sensitivity
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	To measure alpha band (8-12Hz) power

Trial Locations

Locations (1)

Dr. Tami Bar-Shalita; 🇮🇱 Tel Aviv, Israel