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

NCT03837795 | Completed

• 1 other identifier: 1710.18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Modulation Disorder; Sensory Over-Responsivity

Keywords

Neurofeedback; Sensory Modulation Disorder; Sensory Over-Responsivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• 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

Other Outcomes (1)

• Auditory Evoked Related Potentials (AERP)

  3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment

Study Arms (1)

Neurofeedback therapy group

EXPERIMENTAL

Device: Neurofeedback treatment

Interventions

Neurofeedback treatment 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).

Neurofeedback therapy group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having SOR indicated by a score higher than 2.39 on the Sensory Responsiveness Questionnaire-Aversive scale.
• free of analgesic medicines for no less than 24 hours before the sessions.
• independent functioning in the community.
• fluency in understanding and reading Hebrew

You may not qualify if:

• metabolic, psychiatric, neurological, or neuro-developmental, but ADHD diagnosis
• acute or chronic pain.
• regular intake of neurological, psychiatric and analgesic medicines.
• participating in other therapies (i.e., cognitive therapies) at present.
• substance abuse.
• pregnancy.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Dr. Tami Bar-Shalita

Tel Aviv, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The researcher that will perform the measurement assessments will differ from the one that will provide the therapy sessions.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: February 12, 2019
• Study Start: May 1, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

IL (1)