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Understanding Pain in Individuals with Intellectual Disability

This study aims to understand how people with intellectual disability (ID) experience pain compared to those without ID. Researchers will use a device called the TSA2 Thermosensory Stimulator to apply different temperatures to the skin, measuring how the brain responds to these sensations. The study will enroll 215 participants, aged 8 to 30 years, including individuals with ID and healthy volunteers. The main goal is to measure pain perception quantitatively at the end of the study. The current status of this trial is unclear.

Study design
This is an interventional study planning to enroll 215 participants, including individuals with intellectual disability and healthy volunteers. It is not specified if the study is randomized or blinded.
What's involved
You will have a physical exam and take a test to measure your level of intellectual disability (if applicable). You will answer questions about pain and how your body reacts to it. The study requires one visit of up to 4 hours, or up to 5 shorter visits for participants with ID.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, pain perception, is measured at the end of the study. No further follow-up is specified.

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NCT05473429

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Recruiting
NAAges 8–30InterventionalBasic science
National Institutes of Health Clinical Center (CC)
~215 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:TSA2 Thermosensory Stimulator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Provide quantitative measure of pain perception
Measured over End of study

Conditions

Intellectual Disability

Explore related trials

Intellectual Disability

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Zenaide MN Quezado, M.D. · PRINCIPAL_INVESTIGATOR · National Institutes of Health Clinical Center (CC)

Who to contact

Zenaide MN Quezado, M.D.
[email protected]
(301) 827-1271
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form by participant or parent / Legally Authorized Representative (LAR) of patient.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, aged 8-30 years of age.
Agreement to avoid use of analgesics, NSAIDs, caffeine (24 hours before procedures), illicit substances and alcohol within 2 days prior to enrollment and during study participation.
IQ 85 OR General Adaptive Composite ABAS-3 score above 85
Must be fluent in the English Language.
OR ABAS-3 score above 85.
Must be fluent in the English Language.
Diagnosis of Intellectual Disability.

Exclusion

NIH employees or children of NIH employee who subordinate to an investigator in this study will be excluded. This will ensure that participation or refusal to participate cannot be perceived as having any beneficial or adverse effects on their employment. There will be no direct solicitation of employees or of employees' children by the employee's supervisor.
Allergic reactions to EEG water based gel.
History of concussions in individuals with an IQ\>85.
Uncontrolled seizures.
Pregnancy (verbal confirmation). Pregnant women will be excluded as there is no data on the effects of nociception in pregnancy.
For healthy volunteers only - known history of neurological, psychiatric or pain disorders.
History of head injury resulting in prolonged loss of consciousness in individuals with an IQ\>85.
Children who have been diagnosed with neurodevelopmental disorders or treated in early intervention programs.
Subjects who are on opioids, NSAID, gabapentin, or pregabalin chronically.

What this trial measures

  • Provide quantitative measure of pain perceptionEnd of study

    a. fNIRS: oxygenated hemoglobin. b.EEG: Theta, alpha, beta, and gamma oscillations across the cortex as measured by EEG time-frequency analysis. c. Pain thresholds (electrical perception threshold; electric tolerance threshold) d. Correlation between brain signals (oxygenated hemoglobin; theta, alpha, beta and gamma oscillations) to pain with behavioral assessments of pain, general functioning and sensory processing