NCT05473429

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Recruiting now NA Last updated 14 April 2026

What this trial tests

NA trial testing TSA2 Thermosensory Stimulator in Intellectual Disability in 215 participants. Currently enrolling.

Timeline

27 March 2026

Primary endpoint
6 October 2026

6 October 2026

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	215
Start date	27 March 2026
Primary completion	6 October 2026
Estimated completion	6 October 2026
Sites	1 location across United States

Drugs / interventions tested

• TSA2 Thermosensory Stimulator

Conditions studied

• Intellectual Disability — all drugs for Intellectual Disability →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 8 to 30, any sex, with Intellectual Disability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lactate metabolism and lactylation in cardiovascular disease: novel mechanisms and therapeutic targets.
   Zhang H, Zhao J, Yu J, Zhang X, et al · · 2024 · cited 14× · PMID 39664763 · DOI 10.3389/fcvm.2024.1489438