Pain in Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT03413241|
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : April 10, 2019
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||172 participants|
|Official Title:||Pain in Autism Spectrum Disorder (ASD): A Psychophysical and Neurophysiological Exploration of Pain Sensitivity and Its Relation to Clinical Characteristics|
|Actual Study Start Date :||May 6, 2018|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
- Pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD [ Time Frame: 4 years ]To explore the pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413241
|Contact: David Yarnitsky, MD||+972 email@example.com|
|Contact: Yelena Granovsky, PhD||+972 firstname.lastname@example.org|
|The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center||Recruiting|
|Contact: Yelena Granovsky, PhD +972 502065750|
|Principal Investigator: David Yarnitsky, MD|