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

Sensory Over-Responsivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837795
• Other study ID #: 1710.18
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: April 2021
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sensory Modulation Disorder
• Sensory Over-Responsivity

Intervention

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).

Locations

Country	Name	City	State
Israel	Dr. Tami Bar-Shalita	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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