Skip to content
Bored Studies
RecruitingAccepts healthy volunteers

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

National Institutes of Health Clinical Center (CC) · NCT05473429

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8–30 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
215
US sites recruiting
1
Study start
March 27, 2026
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TSA2 Thermosensory Stimulator

Conditions: Intellectual Disability

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • 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

  • IQ above 85 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.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov

Study contacts (from the official record)

  • Zenaide MN Quezado, M.D. · (301) 827-1271 · zquezado@cc.nih.gov
All healthy volunteers studies in Maryland →
Characterization of Nociception Phenotype in Individuals With… (NCT05473429) | Bored Studies