Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03413241
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2018-01-21
Brief Title:
Pain in Autism Spectrum Disorder
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Pain in Autism Spectrum Disorder ASD A Psychophysical and Neurophysiological Exploration of Pain Sensitivity and Its Relation to Clinical Characteristics
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed project will be first performed on individuals with HF-ASD with their expected heterogeneity and healthy control HC subjects in order to explore the pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD Secondly we will focus on individuals with ASD and HC without ASR ASD-nonASR HC-nonASR and with SHR ASD-SHR HC-SHR This 2X2 factorial design will enable us to determine whether the feature of SHR in individuals with HF-ASD contributes to pain sensitivity This research project will comprise of two sessions Session I will include the following tests ADOS-2 for ASD diagnosing only for individuals with ASD intelligence quotation testing IQ Wechsler Abbreviated Scale of Intelligence - Second Edition WASI-II107 serving for inclusion criteria Session II will include familiarization with the researchers and lab thermal detection threshold testing for small fiber abnormality identification since detection thresholds in some reports found to be abnormal pain threshold testing and completion of questionnaires see section 36 for details psychophysical testing and EEG recordings in the following order i rEEG recordings ii psychophysical pain assessments simultaneously with iii neurophysiological pain assessments with pain EPs recorded Our research protocol will be approved by the Helsinki Committee of the Rambam Health Care Center and The Chaim Sheba Medical Center
Detailed Description:
A dysregulation of the balance between excitatory and inhibitory neural activity ie an EI imbalance underlies ASD pathology Neural hyper-responsiveness and impaired top-down modulation represent the EI imbalance underpinning the ASD clinical characteristics One of the most frequent ASD characteristics is atypical sensory responsiveness including exaggerated behavioral responses to sensory stimuli ie sensory hyper-responsiveness In healthy subjects sensory hyper-responsiveness was found to be associated with pain hyper-sensitivityThis study project aims to study whether 1 the individuals with ASD exhibit pain hyper-sensitivity namely a pro-nociceptive profile supported by the EI 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None