Actively Recruiting

Phase Not Applicable
Age: 8Years - 30Years
All Genders
Healthy Volunteers
NCT05473429

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Led by National Institutes of Health Clinical Center (CC) · Updated on 2026-05-12

215

Participants Needed

1

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 form by participant or legally authorized representative.
  • Willingness to comply with study procedures and availability for the study duration.
  • Male or female aged 8 to 30 years.
  • Agreement to avoid analgesics, NSAIDs, caffeine (24 hours before procedures), illicit substances, and alcohol within 2 days prior to enrollment and during study participation.
  • For healthy adult controls: IQ above 85 and fluent in English.
  • For healthy children: IQ above 85 and fluent in English.
  • For patients: diagnosis of intellectual disability.
Not Eligible

You will not qualify if you...

  • NIH employees or children of NIH employees who are subordinates to an investigator in this study.
  • Allergic reactions to EEG water-based gel.
  • History of concussions in individuals with IQ above 85.
  • Uncontrolled seizures.
  • Pregnancy (verbal confirmation).
  • For healthy volunteers only: known history of neurological, psychiatric, or pain disorders.
  • History of head injury with prolonged loss of consciousness in individuals with IQ above 85.
  • Healthy children diagnosed with neurodevelopmental disorders or treated in early intervention programs.
  • Patients on chronic opioids, NSAIDs, gabapentin, or pregabalin.

AI-Screening

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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.

CONTACT

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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Characterization of Nociception Phenotype in Individuals With Intellectual Disability | DecenTrialz