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NCT05473429 · ClinicalTrials.gov registry record · NA
Characterization of Nociception Phenotype in Individuals With Intellectual Disability
A NA study of Intellectual Disability, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- NA
- Development phase
- 215
- Enrollment target
- 1
- Study location
NCT05473429: Recruiting NA study of Intellectual Disability, sponsored by National Institutes of Health Clinical Center (CC).
NCT05473429 is a NA study of Intellectual Disability that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 215 participants, below the 346-participant average among 26 other Intellectual Disability trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05473429, a NA study of Intellectual Disability, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
a. fNIRS: oxygenated hemoglobin. b.EEG: Theta, alpha, beta, and gamma oscillations across the cortex as measured by EEG time-frequency analysis. c. Pain thresholds (electrical perception threshold; electric tolerance threshold) d. Correlation between brain signals (oxygenated hemoglobin; theta, alpha, beta and gamma oscillations) to pain with behavioral assessments of pain, general functioning and sensory processing
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 |
What NCT05473429 shows while recruiting
NCT05473429 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 346-participant average among 26 other Intellectual Disability trials with a reported enrollment target (38% lower).
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.
NCT05473429 reports a single indexed study location in Maryland.
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.
What interventions are being tested in trial NCT05473429?
The interventions under investigation include: TSA2 Thermosensory Stimulator (DEVICE).
Who is sponsoring clinical trial NCT05473429?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Intellectual Disability
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05473429's enrollment target sits among peer trials
215 8th of 26 higher than 19 of 26 other Intellectual Disability trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intellectual Disability trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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