Autism Spectrum Disorder (ASD)PPiANCT06659731
Quantitative Sensory Testing to Study Pain Perception in Autism
An observational study of Autism Spectrum Disorder (ASD) and Pain Perception, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Pain Perception
- What is being tested?
- Quantitative Sensory testing (QST) and EEG
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2024to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and adolescent between 5 and 17 years old
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS "E. Medea"
Brindisi, BR, 72100
Valentina Nicolardi, 0039 3200598331, valentina.nicolardi@lanostrafamiglia.it
valentina nicolardi, PhD
About this study
Official title: Pain Perception in Autism. Study Through Quantitative Sensory Testing and Psychophysiological Correlates
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder (ASD), Pain Perception
- Being tested
- Quantitative Sensory testing (QST), EEG
- Keywords
- autism spectrum disorder (ASD), pain perception, somatosensory profile, children, QST
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
EEGOther
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).
| Study group | Role | What they receive |
|---|---|---|
| ASD Group | Patients with ASD diagnosis according to DSM-V, between 5 and 17 years old Receives: 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 Receives: Other: Quantitative Sensory testing (QST); Other: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG responses in the time domain
ERPs amplitude (μV)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from the enrollment to the end of QST administration (approx. 2 days)
EEG responses in the time-frequency domain
Power-spectrum of eeg responses
Measured: from the enrollment to the end of QST administration (approx. 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start17 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659731
- Sponsor's protocol ID
- id. 1043
- Acronym
- PPiA
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36730631Vaughan 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.
PubMed 30771132Chien 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.
PubMed 33055277Frundt 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.
PubMed 28160223ZHANG 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.
PubMed 24687688Nicolardi 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.
PubMed 40376609
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception in Autism. Study Through Quantitative Sensory Testing and Psychophysiological Correlates
- ClinicalTrials.gov ID
- NCT06659731
- Acronym / sponsor ID
- PPiA / id. 1043
- Conditions
- Autism Spectrum Disorder (ASD), Pain Perception
- Keywords
- autism spectrum disorder (ASD), pain perception, somatosensory profile, children, QST
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD Group | – | Other: Quantitative Sensory testing (QST), Other: EEGPatients with ASD diagnosis according to DSM-V, between 5 and 17 years old |
| Control Group | – | Other: Quantitative Sensory testing (QST), Other: EEGHealthy participants, between 5 and 17 years old, without ASD diagnosis and withour neurological and psychiatric deseases |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and adolescent between 5 and 17 years old
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- peripheral neuropaties;
- psychiatric diagnosis as psychosis,
- Tourette Syndrome,
- neurological diagnoses as epilepsy,
- sensory deficit or loss;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | ASD Group, Control Group |
| EEGEEG 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). | Other | ASD Group, Control Group |
Primary outcome
EEG responses in the time domain
Time frame: from the enrollment to the end of EEG recordin (approx. 3 days)
ERPs amplitude (μV)
Cold detection threshold
Time frame: from the enrollment to the end of QST administration (approx. 2 days)
The minimum intensity value (°C) at which a cold stimulus is perceived by each participant
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
Cold pain threshold
Time frame: from the enrollment to the end of QST administration (approx. 2 days)
The minimum intensity value (°C) at which a cold stimulus is perceived as painful by each participant
Warm pain 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 as painful by each participant
Mechanical detection threshold
Time frame: from the enrollment to the end of QST administration (approx. 2 days)
The minimum intensity value (mN) at which a mechanical stimulus is perceived by each participant. It is a measure of touch perception
Mechanical pain threshold
Time frame: from the enrollment to the end of QST administration (approx. 2 days)
The minimum intensity value (mN) at which a mechanical stimulus is perceived as painful by each participant.
Vibration detection threshold
Time frame: from the enrollment to the end of QST administration (approx. 2 days)
The minimum intensity value (Hz) at which a vibratory stimulus is perceived by each participant.
Pressure pain threshold
Time frame: from the enrollment to the end of QST administration (approx. 2 days)
The minimum intensity value (N) at which a pressure stimulus is perceived as painful by each participant.
EEG responses in the time-frequency domain
Time frame: from the enrollment to the end of QST administration (approx. 3 days)
Power-spectrum of eeg responses
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 36730631Hoffman 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.
- Background: PubMed 30771132Vaughan 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.
- Background: PubMed 33055277Chien 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.
- Background: PubMed 28160223Frundt 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.
- BackgroundZHANG 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
- BackgroundProff I, Williams GL, Quadt L, Garfinkel SN. Sensory processing in autism across exteroceptive and interoceptive domains. Psychology & Neuroscience 2022;15(2):105
- Background: PubMed 24687688Moore 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.
- Derived from this study: PubMed 40376609Nicolardi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder (ASD) and Pain Perception, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Nicolardi, PhD (0039 3200598331, valentina.nicolardi@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG responses in the time domain (time frame: from the enrollment to the end of EEG recordin (approx. 3 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06659731, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.