Pain in Autism Spectrum Disorder

NCT03413241 | Completed

• 1 other identifier: ASD 0496-17-RMB
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

High-functioning Autism

Keywords

autism spectrum disorder

Outcome Measures

Primary Outcomes (1)

• Pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD

  To explore the pain processing and modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD

  4 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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,

You may qualify if:

• 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.

You may not qualify if:

• \) Diagnosis of chronic pain.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

The lab of clinical neurophysiology, the faculty of medicine, Technion and Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 29, 2018
• Study Start: May 6, 2018
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

IL (1)