RecruitingNot ApplicableNCT05473429

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Characterization of the Nociception Phenotype in Individuals With Intellectual Disability

Sponsor

National Institutes of Health Clinical Center (CC)

Enrollment

215 participants

Start Date

Mar 27, 2026

Study Type

INTERVENTIONAL

Conditions

Intellectual Disability

Summary

Background: People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID. Objective: To compare brain responses to unpleasant stimuli in people with and without ID. Eligibility: People aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed. Design: The study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead. Participants will take a test to measure their level of ID. They will have a physical exam. Both groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot. Both groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers. Participants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces.

Eligibility

Min Age: 8 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study examines how people with intellectual disability (ID) perceive and respond to pain (nociception). Researchers compare brain activity and pain sensitivity between people with ID, healthy children, and healthy adults to better understand pain in those who cannot easily communicate it. You may be eligible if: - You are between 8 and 30 years old - You (or a parent/guardian) can provide signed consent - You are willing to avoid pain medications, NSAIDs, caffeine, alcohol, and illicit substances for 2 days before and during the study - For healthy controls: your IQ is above 85 and you are fluent in English - For patients: you have a diagnosis of intellectual disability You may NOT be eligible if: - You are an NIH employee or child of an NIH employee supervised by a study investigator - You have an allergy to EEG water-based gel - You have uncontrolled seizures - You are pregnant - You have a history of concussion (for those with IQ above 85) - You (as a healthy volunteer) have a known neurological, psychiatric, or pain disorder - You are a healthy child who was diagnosed with a neurodevelopmental disorder or participated in early intervention - You are a patient currently on opioids, NSAIDs, gabapentin, or pregabalin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETSA2 Thermosensory Stimulator

TSA thermal analyzer uses the thresholds for four sub-modalities to measure thermal sensory threshold. This device is capable of heating or cooling the skin as needed to detect heat and cold tolerance and to deliver thermal stimuli.