Quantitative Sensory Testing to Study Pain Perception in Autism
NCT ID: NCT06659731
Last Updated: 2024-10-26
Study Results
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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RECRUITING
50 participants
OBSERVATIONAL
2024-07-17
2025-09-30
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
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)
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
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)
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
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* peripheral neuropaties;
* psychiatric diagnosis as psychosis,
* Tourette Syndrome,
* neurological diagnoses as epilepsy,
* sensory deficit or loss;
* genetic diseases
5 Years
17 Years
ALL
Yes
Sponsors
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IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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IRCCS "E. Medea"
Brindisi, BR, Italy
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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
Proff I, Williams GL, Quadt L, Garfinkel SN. Sensory processing in autism across exteroceptive and interoceptive domains. Psychology & Neuroscience 2022;15(2):105
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.
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.
Other Identifiers
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id. 1043
Identifier Type: -
Identifier Source: org_study_id
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