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NCT Number: NCT06659731

Quantitative Sensory Testing to Study Pain Perception in Autism

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Pain Perception

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS "E. Medea"

Brindisi, BR, 72100, Italy

Location status: Recruiting

Location contact

Valentina Nicolardi

CONTACT

[email protected]

0039 3200598331

valentina nicolardi, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

EEG

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).

Primary outcomes

  1. EEG responses in the time domain

    Time frame: from the enrollment to the end of EEG recordin (approx. 3 days)

    ERPs amplitude (μV)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina Nicolardi, PhD

CONTACT

[email protected]

0039 3200598331

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

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

Acronym: PPiA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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