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

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ClinicalTrials.gov Identifier: NCT03837795
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Tami Bar-Shalita, Tel Aviv University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sensory Modulation Disorder Sensory Over-Responsivity Device: Neurofeedback treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
Masking: None (Open Label)
Masking Description: The researcher that will perform the measurement assessments will differ from the one that will provide the therapy sessions.
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : October 15, 2020
Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Pain Sensitivity Questionnaire (PSQ) [ Time Frame: 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

  2. Electroencephalogram (EEG) Resting State [ Time Frame: 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


Other Outcome Measures:
  1. Auditory Evoked Related Potentials (AERP) [ Time Frame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837795


Locations
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Israel
Dr. Tami Bar-Shalita
Tel Aviv, Israel
Sponsors and Collaborators
Tel Aviv University
More Information
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Responsible Party: Tami Bar-Shalita, Principal Investigator, Tel Aviv University
ClinicalTrials.gov Identifier: NCT03837795    
Other Study ID Numbers: 1710.18
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tami Bar-Shalita, Tel Aviv University:
Neurofeedback
Sensory Modulation Disorder
Sensory Over-Responsivity