Clinical trial NCT03837795: Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Modulation Disorder
Sensory Over-Responsivity
Keywords: Neurofeedback
Sensory Modulation Disorder
Sensory Over-Responsivity
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: it is a serial experimental research design, which includes 10 individuals with sensory over responsivity aged 21-45 years will participate
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The Satisfaction with Life Scale (SWLS)
timeFrame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
measure: Goal Attainment Scaling (GAS)
timeFrame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
measure: The World Health Organization Disability Assessment Schedule (WHODAS-2.0)
timeFrame: assesses the change between the baseline (3 weeks pre-treatment), and after 28 days from the last treatment session
Secondary outcomes:
measure: Pain Sensitivity Questionnaire (PSQ)
timeFrame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
measure: Electroencephalogram (EEG) Resting State
timeFrame: 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:
measure: Auditory Evoked Related Potentials (AERP)
timeFrame: 3 weeks pre-treatment, 2 days before first treatment session, two days after the last treatment session and after month of the treatment
Locations:
city: Tel Aviv
country: Israel
facility: Dr. Tami Bar-Shalita
Study officials:
References: