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

NCT ID: NCT03837795

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-10-15

Brief Summary

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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

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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.

Conditions

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Sensory Modulation Disorder Sensory Over-Responsivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Neurofeedback therapy group

Group Type EXPERIMENTAL

Neurofeedback treatment

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Tami Bar-Shalita

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Tami Bar-Shalita

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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1710.18

Identifier Type: -

Identifier Source: org_study_id

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