Dr. Tami Bar-Shalita
Tel Aviv, Israel
NCT Number: NCT03837795
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.
Looking for future studies?
Notify Me21 year–45 year
All sexes
Interventional
Not applicable
Tel Aviv, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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
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
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
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
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
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.
Tel Aviv University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06818344
Brain Diseases, Central Nervous System Diseases
Bolu, Turkey (Türkiye)
View Trial Details