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Characterization of Nociception Phenotype in Individuals With Intellectual Disability
NCT05473429 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE TSA2 Thermosensory Stimulator
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2026-10-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05473429
The ClinicalTrials.gov registry entry for NCT05473429 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 209 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Intellectual Disability appearing as the primary indexed condition, and to 1 intervention — of which TSA2 Thermosensory Stimulator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05473429 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05473429 about?
NCT05473429 is a clinical study titled "Characterization of Nociception Phenotype in Individuals With Intellectual Disability". 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. Objecti...
What is the current status of trial NCT05473429?
This trial is currently recruiting. It is a NA study. The enrollment target is 215 participants. The study started on 2026-03-26. Estimated completion is 2026-10-06.
What conditions does trial NCT05473429 study?
This clinical trial studies the following conditions: Intellectual Disability. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05473429?
The interventions under investigation include: TSA2 Thermosensory Stimulator (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05473429?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 209 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05473429 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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