Actively Recruiting

Phase Not Applicable
Age: 8Years - 30Years
All Genders
Healthy Volunteers
ID05473429

Characterization of the Nociception Phenotype in Individuals With Intellectual Disability

Led by National Institutes of Health Clinical Center (CC) · Updated on 2026-06-01

215

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how people with intellectual disability (ID) respond to unpleasant sensations compared to those without ID. The goal is to understand brain activity and pain perception in individuals aged 8 to 30 years with ID versus healthy volunteers. This research addresses the gap in knowledge about pain experiences in people with ID, who often have additional physical disabilities affecting their nerves, bones, muscles, and gastrointestinal systems. The study involves a special device called the TSA2 Thermosensory Stimulator to provide heat, cold, brushing, and mild electrical stimuli to various body parts. Brain responses will be measured using electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS). Participants will wear a sensor cap and have sensors placed on their chest, fingers, and around their body to monitor heart rate, breathing, sweat, and brain activity during the stimuli. There are two groups: individuals with intellectual disability and healthy controls. Participants will attend one visit lasting up to four hours, though those with ID may have up to five shorter visits. They will undergo tests to assess intellectual disability level, physical exams, and answer questions about pain, sensory responses, and social behavior. Caregivers may assist if needed. The study will measure brain activation, physiological responses like heart rate and skin conductance, and behavioral reactions to stimuli. The primary outcome is to provide a quantitative measure of pain perception by the study's end.

CONDITIONS

Brief Title

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Who Can Participate

Age: 8Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by participant or legally authorized representative
  • Willingness to follow all study procedures and be available for the study duration
  • Male or female, aged 8 to 30 years
  • Agreement to avoid analgesics, NSAIDs, caffeine for 24 hours before procedures and avoid illicit substances and alcohol for 2 days before and during the study
  • Healthy controls must have IQ above 85 and be fluent in English
  • Patients must have a diagnosis of intellectual disability
Not Eligible

You will not qualify if you...

  • NIH employees or their children under investigators in this study
  • Allergic reactions to EEG water-based gel
  • History of concussions or head injury with prolonged unconsciousness in individuals with IQ above 85
  • Uncontrolled seizures
  • Pregnancy (by verbal confirmation)
  • Healthy volunteers with known neurological, psychiatric, or pain disorders
  • Healthy children diagnosed with neurodevelopmental disorders or treated in early intervention programs
  • Patients on chronic opioids, NSAIDs, gabapentin, or pregabalin treatment
  • Participants with pregnancy or uncontrolled seizures are excluded due to safety concerns in this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 1 day

Participants undergo somatosensory testing using a thermal stimulator device to evaluate brain activation patterns and physiological responses to innocuous and noxious stimuli.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

Z

Zenaide MN Quezado, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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