Quantitative Sensory Testing to Study Pain Perception in Autism

NCT06659731 | Recruiting

• 1 other identifier: id. 1043
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at assess sensory perception, and pain perception, in neurodivergent children and adolescent in the autism spectrum. To achieve this goal, the quantitive sensory testing (QST), a controlled and replicable protocol, will be used, to assess perception in different sensory modalities: heat sensations, mechanical detection threshold and pain threshold. As secondary aim, the cortical processing of thermal painful stimuli will be collected through electroencephalography (EEG) in order to investigate if there are differences in the cortical processing of painful stimuli between clinical sample and control sample, and if it could be associated with differences in the subjective experience between the two groups. Finally, it will be explored the association between such differences, and indexes of psychopathology and dispositional measures.

Conditions

Autism Spectrum Disorder (ASD); Pain Perception

Keywords

autism spectrum disorder (ASD); pain perception; somatosensory profile; children; QST

Outcome Measures

Primary Outcomes (10)

• EEG responses in the time domain

  ERPs amplitude (μV)

  from the enrollment to the end of EEG recordin (approx. 3 days)

• Cold detection threshold

  The minimum intensity value (°C) at which a cold stimulus is perceived by each participant

  from the enrollment to the end of QST administration (approx. 2 days)

• Warm detection threshold

  The minimum intensity value (°C) at which a warm stimulus is perceived by each participant

  from the enrollment to the end of QST administration (approx. 2 days)

• Cold pain threshold

  The minimum intensity value (°C) at which a cold stimulus is perceived as painful by each participant

  from the enrollment to the end of QST administration (approx. 2 days)

• Warm pain threshold

  The minimum intensity value (°C) at which a warm stimulus is perceived as painful by each participant

  from the enrollment to the end of QST administration (approx. 2 days)

• Mechanical detection threshold

  The minimum intensity value (mN) at which a mechanical stimulus is perceived by each participant. It is a measure of touch perception

  from the enrollment to the end of QST administration (approx. 2 days)

• Mechanical pain threshold

  The minimum intensity value (mN) at which a mechanical stimulus is perceived as painful by each participant.

  from the enrollment to the end of QST administration (approx. 2 days)

• Vibration detection threshold

  The minimum intensity value (Hz) at which a vibratory stimulus is perceived by each participant.

  from the enrollment to the end of QST administration (approx. 2 days)

• Pressure pain threshold

  The minimum intensity value (N) at which a pressure stimulus is perceived as painful by each participant.

  from the enrollment to the end of QST administration (approx. 2 days)

• EEG responses in the time-frequency domain

  Power-spectrum of eeg responses

  from the enrollment to the end of QST administration (approx. 3 days)

Study Arms (2)

ASD Group

Patients with ASD diagnosis according to DSM-V, between 5 and 17 years old

Other: Quantitative Sensory testing (QST); Other: EEG

Control Group

Healthy participants, between 5 and 17 years old, without ASD diagnosis and withour neurological and psychiatric deseases

Other: Quantitative Sensory testing (QST); Other: EEG

Interventions

Quantitative Sensory testing (QST) OTHER

The QST protocol (Rolke et al., 2006; Blankenburg et al., 2010), implies the administration of 7 short sensory test in order to measure up to 13 parameters, which can be grouped as follows: thermal detection thresholds for the perception of cold, warm and paradoxical heat sensations, thermal pain thresholds for cold and hot stimuli, mechanical detection thresholds for touch and vibration, mechanical pain thresholds and sensitivity for pinprick and blunt pressure, vibration detection threshold and pressure pain threshold.

ASD Group; Control Group

EEG OTHER

EEG recording at rest and while receiving heat stimuli to study cortical processing of salient thermal stimuli. Up to 30 painful thermal stimuli, will be delivered to the patients' hand dorsum in order to register contact heat evoked potentials (CHEPs).

ASD Group; Control Group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescent between 5 and 17 years old

You may qualify if:

• Children and adolescent
• age between 5 and 17 years old
• Autism diagnosis according to DSM-V criteria
• healthy children and adolescent (without neurological, and psychiatric, diagnoses)
• age between 5 and 17 years old

You may not qualify if:

• Comorbidities with (for the clinical sample) or diagnosis of (for the control sample):
• peripheral neuropaties;
• psychiatric diagnosis as psychosis,
• Tourette Syndrome,
• neurological diagnoses as epilepsy,
• sensory deficit or loss;
• genetic diseases

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS "E. Medea"

Brindisi, BR, 72100, Italy

RECRUITING

Related Publications (8)

• Hoffman T, Bar-Shalita T, Granovsky Y, Gal E, Kalingel-Levi M, Dori Y, Buxbaum C, Yarovinsky N, Weissman-Fogel I. Indifference or hypersensitivity? Solving the riddle of the pain profile in individuals with autism. Pain. 2023 Apr 1;164(4):791-803. doi: 10.1097/j.pain.0000000000002767. Epub 2022 Aug 26.

  PMID: 36730631 BACKGROUND

• Vaughan S, McGlone F, Poole H, Moore DJ. A Quantitative Sensory Testing Approach to Pain in Autism Spectrum Disorders. J Autism Dev Disord. 2020 May;50(5):1607-1620. doi: 10.1007/s10803-019-03918-0.

  PMID: 30771132 BACKGROUND

• Chien YL, Chao CC, Wu SW, Hsueh HW, Chiu YN, Tsai WC, Gau SS, Hsieh ST. Small fiber pathology in autism and clinical implications. Neurology. 2020 Nov 10;95(19):e2697-e2706. doi: 10.1212/WNL.0000000000010932. Epub 2020 Oct 14.

  PMID: 33055277 BACKGROUND

• Frundt O, Grashorn W, Schottle D, Peiker I, David N, Engel AK, Forkmann K, Wrobel N, Munchau A, Bingel U. Quantitative Sensory Testing in adults with Autism Spectrum Disorders. J Autism Dev Disord. 2017 Apr;47(4):1183-1192. doi: 10.1007/s10803-017-3041-4.

  PMID: 28160223 BACKGROUND

• ZHANG Wenyun LX, YAO Junjie, YE Qian, PENG Weiwei. Abnormalities in pain sensitivity among individuals with autism spectrum disorder: Evidence from meta-analysis. Acta Psychologica Sinica 2021;53(6):613-628

  BACKGROUND

• Proff I, Williams GL, Quadt L, Garfinkel SN. Sensory processing in autism across exteroceptive and interoceptive domains. Psychology & Neuroscience 2022;15(2):105

  BACKGROUND

• Moore DJ. Acute pain experience in individuals with autism spectrum disorders: a review. Autism. 2015 May;19(4):387-99. doi: 10.1177/1362361314527839. Epub 2014 Mar 31.

  PMID: 24687688 BACKGROUND

• Nicolardi V, Fanizza I, Accogli G, Scoditti S, Trabacca A. Pain perception in autism. A study of sensory reactivity in children and adolescents with autism using quantitative sensory testing and psychophysiological correlates. Front Neurosci. 2025 May 1;19:1543538. doi: 10.3389/fnins.2025.1543538. eCollection 2025.

  PMID: 40376609 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Valentina Nicolardi, PhD

CONTACT

0039 3200598331; valentina.nicolardi@lanostrafamiglia.it

Study Design

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

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 26, 2024
• Study Start: July 17, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

IT (1)