Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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