Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT05473429
Status
Recruiting
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Conditions

  • Intellectual Disability

Eligibility Criteria

Sex
ALL
Age
8 Years - 30 Years
Healthy Volunteers
Accepted

Interventions

  • TSA2 Thermosensory Stimulator — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 27, 2026
Status verified
May 2026
Primary completion
Oct 6, 2026
Completion
Oct 6, 2026

Study Design

Enrollment
215 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1/ID patients
    ID Patients
  • Active Comparator: 2/Healthy controls
    Healthy controls

Primary Outcome Measure

Provide quantitative measure of pain perception [ Time Frame: End of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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