Quantitative Sensory Testing to Study Pain Perception in Autism

Официальное название

Pain Perception in Autism. Study Through Quantitative Sensory Testing and Psychophysiological Correlates

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 an
• Другое 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).

Первичные конечные точки

• EEG responses in the time domain [Срок оценки: from the enrollment to the end of EEG recordin (approx. 3 days)]
• Cold detection threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Warm detection threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Cold pain threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Warm pain threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Mechanical detection threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Mechanical pain threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Vibration detection threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• Pressure pain threshold [Срок оценки: from the enrollment to the end of QST administration (approx. 2 days)]
• EEG responses in the time-frequency domain [Срок оценки: from the enrollment to the end of QST administration (approx. 3 days)]

Критерии участия

Inclusion Criteria for the clinical sample:

• Children and adolescent
• age between 5 and 17 years old
• Autism diagnosis according to DSM-V criteria

Inclusion Criteria for the control sample:

• healthy children and adolescent (without neurological, and psychiatric, diagnoses)
• age between 5 and 17 years old

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 1 центр

• IRCCS "E. Medea" — Brindisi

Публикации

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• 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. PMID 24687688
• 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

Идентификаторы

NCT: NCT06659731 · id. 1043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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