Recruiting

Observational Study

Sponsor:

NIH

Code:

NCT05473429

Conditions

Intellectual Disability

Eligibility Criteria

Sex: All

Age: 8 - 30

Healthy Volunteers: Accepted

Interventions

TSA2 Thermosensory Stimulator

Study Details

Brief 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

Intellectual Disability

Study ID

NCT05473429

Start date

Mar 27, 2026

Status verified date

Jul 9, 2026

Completion date

Oct 6, 2026

Anticipated

Primary completion date

Oct 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 30

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

For All Participants

  • Provision of signed and dated informed consent form by participant or parent / Legally Authorized Representative (LAR) of patient.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged 8-30 years of age.
  • Agreement to avoid use of analgesics, NSAIDs, caffeine (24 hours before procedures), illicit substances and alcohol within 2 days prior to enrollment and during study participation.

Healthy Adult Controls

  • IQ 85 OR General Adaptive Composite ABAS-3 score above 85
  • Must be fluent in the English Language.

Healthy Children

  • OR ABAS-3 score above 85.
  • Must be fluent in the English Language.

Patients

-Diagnosis of Intellectual Disability.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

All participants

  • NIH employees or children of NIH employee who subordinate to an investigator in this study will be excluded. This will ensure that participation or refusal to participate cannot be perceived as having any beneficial or adverse effects on their employment. There will be no direct solicitation of employees or of employees' children by the employee's supervisor.
  • Allergic reactions to EEG water based gel.
  • History of concussions in individuals with an IQ>85.
  • Uncontrolled seizures.
  • Pregnancy (verbal confirmation). Pregnant women will be excluded as there is no data on the effects of nociception in pregnancy.
  • For healthy volunteers only - known history of neurological, psychiatric or pain disorders.
  • History of head injury resulting in prolonged loss of consciousness in individuals with an IQ>85.

Healthy Children

-Children who have been diagnosed with neurodevelopmental disorders or treated in early intervention programs.

Patients

-Subjects who are on opioids, NSAID, gabapentin, or pregabalin chronically.

Study Design

Enrollment

215 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 1/ID patients

ID Patients

active comparator: 2/Healthy controls

Healthy controls

Interventions

TSA2 Thermosensory Stimulator

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Zenaide MN Quezado, M.D.

(301) 827-1271zquezado@cc.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institutes of Health Clinical Center (CC)

Last update posted

Aug 31, 2026

Last verified

Jul 9, 2026

Keywords

  • EEG
  • fNIRS
  • Pain Thresholds
  • Brain Signals
  • Quantitative Sensory Testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC) on 2026-08-31.