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Pain in Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03413241
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
Rambam Health Care Campus

Tracking Information
First Submitted Date January 21, 2018
First Posted Date January 29, 2018
Last Update Posted Date April 10, 2019
Actual Study Start Date May 6, 2018
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03413241 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Pain in Autism Spectrum Disorder
Official Title Pain in Autism Spectrum Disorder (ASD): A Psychophysical and Neurophysiological Exploration of Pain Sensitivity and Its Relation to Clinical Characteristics
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®-II)107, 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 3.6 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 (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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 80 adults (18-45 years) diagnosed with HF-ASD, and up to 92 healthy subjects, controlled for age, sex and IQ,
Condition High-functioning Autism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2018)
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2022
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Proficiency in using the Hebrew language;
  2. Verbal performance and full scale estimate of 80 and above on the WASI
  3. No use of pain medication for the past 24 hours.
  4. Inclusion criteria for the ASD group: A diagnosis of HF-ASD based on the ADOS-2

Exclusion Criteria:

1) Diagnosis of chronic pain.

Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contact: David Yarnitsky, MD +972 502062700
Contact: Yelena Granovsky, PhD +972 502065750
Listed Location Countries Israel
Removed Location Countries  
Administrative Information
NCT Number NCT03413241
Other Study ID Numbers ASD 0496-17-RMB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rambam Health Care Campus
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
Investigators Not Provided
PRS Account Rambam Health Care Campus
Verification Date April 2019