- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413241
Pain in Autism Spectrum Disorder
Pain in Autism Spectrum Disorder (ASD): A Psychophysical and Neurophysiological Exploration of Pain Sensitivity and Its Relation to Clinical Characteristics
Study Overview
Status
Conditions
Detailed Description
A dysregulation of the balance between excitatory and inhibitory neural activity (i.e. an E/I imbalance) underlies ASD pathology. Neural hyper-responsiveness and impaired top-down modulation represent the E/I imbalance, underpinning the ASD clinical characteristics. One of the most frequent ASD characteristics is atypical sensory responsiveness, including exaggerated behavioral responses to sensory stimuli (i.e. sensory hyper-responsiveness). In healthy subjects, sensory hyper-responsiveness was found to be associated with pain hyper-sensitivity.This study project aims to study whether : (1) the individuals with ASD exhibit pain hyper-sensitivity, namely a pro-nociceptive profile, supported by the E/I imbalance. (2) the pain sensitivity will be positively associated with ASD clinical characteristics, and (3) sensory hyper-responsiveness will be found to be a contributing factor to pain hyper-sensitivity in ASD individuals.
We will perform a multi-method, comprehensive psychophysical and neurophysiological evaluation of pain sensitivity along with self-reports of clinical characteristics, daily function, and quality of life. The participants will be high functioning ASD (HF-ASD) individuals (IQ >80). Pain processing by means of pain hyperalgesia and pain inhibition capability, along with EEG activity at rest and in response to noxious stimuli (pain-evoked potentials), will be compared between ASD subjects and healthy controls. The best pain-related psychophysical and/or neurophysiological measures differentiating between groups will be tested for correlations with the ASD clinical characteristics. In order to test the contributing role of sensory hyper-responsiveness to pain sensitivity in ASD, the aforementioned psychophysical and neurophysiological evaluation will be performed in 4 homogenous groups: ASD with and without sensory hyper-responsiveness, and controls with and without sensory hyper-responsiveness.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: David Yarnitsky, MD
- Phone Number: +972 502062700
- Email: d_yarnitsky@rambam.health.gov.il
Study Contact Backup
- Name: Yelena Granovsky, PhD
- Phone Number: +972 502065750
- Email: y_granovsky@rambam.health.gov.il
Study Locations
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Haifa, Israel
- The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Proficiency in using the Hebrew language;
- Verbal performance and full scale estimate of 80 and above on the WASI
- No use of pain medication for the past 24 hours.
- Inclusion criteria for the ASD group: A diagnosis of HF-ASD based on the ADOS-2
Exclusion Criteria:
1) Diagnosis of chronic pain.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD
Time Frame: 4 years
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To explore the pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD
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4 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASD 0496-17-RMB
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