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

T

Tel Aviv University

Status

Completed

Conditions

Sensory Over-Responsivity
Sensory Modulation Disorder

Treatments

Device: Neurofeedback treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03837795
1710.18

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Neurofeedback therapy group
Experimental group
Treatment:
Device: Neurofeedback treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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