Quantitative Sensory Testing to Study Pain Perception in Autism

NCT ID: NCT06659731

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-17

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Study procedure imply the following steps: 1. Eligibility assessment according to inclusion and exclusion criteria. 2. Administration of questionnaires and scales for the characterization of clinical aspects of autism: Short sensory profile; The Autism Spectrum Quotient: Children's Version; Vineland Adaptive Behaviour Scales-Second Edition. The Vineland Adaptive Behaviour Scales-Second Edition; The Child Behavior Checklist (CBCL). 3. Administration of Quantitative Sensory Testing to study sensory thresholds and perception. 4. EEG recording at rest as well as while receiving heat stimuli to study cortical processing of salient thermal stimuli.

The QST protocol, 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. Previous research with QST in neurodevelopmental disorders used modified version of the whole protocol, to make it suitable and tolerable for different clinical condition such as developmental delay including motor, communicative, and cognitive impairments. Thus, we will also administer the most suitable and tolerable version of the QST according to each patient condition and needs, for example we plan to reduce the number of stimuli for each stimulation side when needed, in order to reduce stimulus trial duration as well. The whole procedure will be implemented in a kids friendly environment, colourful and comfortable, and sensory stimuli will be adapted in order to avoid fearfulness of the stimuli, thus each stimulation will be presented as a game to be played with a specific animal, and each device and instrument will be covered with animals pictures according to the game it represents. Overall QST last about 1h 30 minutes, it will be divided in at least two sessions according to patients' needs.

The EEG recording consist in the cap montage at first, then a short accommodation with the sensory stimuli in order to find an intensity value for a moderate painful stimulus, to be used for the stimulation. After the preparation/accommodation, the eeg recording will start while a series, up to 30 thermal stimuli, will be delivered to the patients' hand dorsum. The whole eeg recording last about 30 minutes and it will be implemented in one session only.

Conditions

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Autism Spectrum Disorder (ASD) Pain Perception

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ASD Group

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

Quantitative Sensory testing (QST)

Intervention Type 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.

EEG

Intervention Type 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).

Control Group

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

Quantitative Sensory testing (QST)

Intervention Type 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.

EEG

Intervention Type 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).

Interventions

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Quantitative Sensory testing (QST)

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.

Intervention Type OTHER

EEG

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS "E. Medea"

Brindisi, BR, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina Nicolardi, PhD

Role: CONTACT

0039 3200598331

Facility Contacts

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Valentina Nicolardi

Role: primary

0039 3200598331

References

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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.

Reference Type BACKGROUND
PMID: 36730631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30771132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33055277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28160223 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 24687688 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40376609 (View on PubMed)

Other Identifiers

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id. 1043

Identifier Type: -

Identifier Source: org_study_id

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