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

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.

Study Overview

• Status: Completed
• Conditions: Sensory Modulation Disorder; Sensory Over-Responsivity
• Intervention / Treatment: Device: Neurofeedback treatment

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Dr. Tami Bar-Shalita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neurofeedback therapy group	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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): October 15, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: February 9, 2019
• First Posted (ACTUAL): February 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Neurofeedback; Sensory Modulation Disorder; Sensory Over-Responsivity
• Other Study ID Numbers: 1710.18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No