Quantitative Sensory Testing to Study Pain Perception in Autism (PPiA)
Pain Perception in Autism. Study Through Quantitative Sensory Testing and Psychophysiological Correlates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Valentina Nicolardi, PhD
- Phone Number: 0039 3200598331
- Email: valentina.nicolardi@lanostrafamiglia.it
Study Locations
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BR
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Brindisi, BR, Italy, 72100
- Recruiting
- IRCCS "E. Medea"
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Contact:
- Valentina Nicolardi
- Phone Number: 0039 3200598331
- Email: valentina.nicolardi@lanostrafamiglia.it
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Principal Investigator:
- valentina nicolardi, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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ASD Group
Patients with ASD diagnosis according to DSM-V, between 5 and 17 years old
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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 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
|
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 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EEG responses in the time domain
Time Frame: from the enrollment to the end of EEG recordin (approx. 3 days)
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ERPs amplitude (μV)
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from the enrollment to the end of EEG recordin (approx. 3 days)
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Cold detection threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (°C) at which a cold stimulus is perceived by each participant
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from the enrollment to the end of QST administration (approx. 2 days)
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Warm detection threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
|
The minimum intensity value (°C) at which a warm stimulus is perceived by each participant
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from the enrollment to the end of QST administration (approx. 2 days)
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Cold pain threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (°C) at which a cold stimulus is perceived as painful by each participant
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from the enrollment to the end of QST administration (approx. 2 days)
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Warm pain threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (°C) at which a warm stimulus is perceived as painful by each participant
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from the enrollment to the end of QST administration (approx. 2 days)
|
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Mechanical detection threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (mN) at which a mechanical stimulus is perceived by each participant.
It is a measure of touch perception
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from the enrollment to the end of QST administration (approx. 2 days)
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Mechanical pain threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (mN) at which a mechanical stimulus is perceived as painful by each participant.
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from the enrollment to the end of QST administration (approx. 2 days)
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Vibration detection threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (Hz) at which a vibratory stimulus is perceived by each participant.
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from the enrollment to the end of QST administration (approx. 2 days)
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Pressure pain threshold
Time Frame: from the enrollment to the end of QST administration (approx. 2 days)
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The minimum intensity value (N) at which a pressure stimulus is perceived as painful by each participant.
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from the enrollment to the end of QST administration (approx. 2 days)
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EEG responses in the time-frequency domain
Time Frame: from the enrollment to the end of QST administration (approx. 3 days)
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Power-spectrum of eeg responses
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from the enrollment to the end of QST administration (approx. 3 days)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- id. 1043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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