RECRUITING

Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Characterization of the Nociception Phenotype in Individuals With Intellectual Disability

Quick Facts

Study Start:2025-12-02
Study Completion:2026-10-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05473429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form by participant or parent / Legally Authorized Representative (LAR) of patient.
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. * Male or female, aged 8-30 years of age.
  4. * 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.
  5. * IQ above 85.
  6. * Must be fluent in the English Language.
  7. * IQ above 85.
  8. * Must be fluent in the English Language.
  1. * 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.
  2. * Allergic reactions to EEG water based gel.
  3. * History of concussions in individuals with an IQ\>85.
  4. * Uncontrolled seizures.
  5. * Pregnancy (verbal confirmation). Pregnant women will be excluded as there is no data on the effects of nociception in pregnancy.
  6. * For healthy volunteers only - known history of neurological, psychiatric or pain disorders.
  7. * History of head injury resulting in prolonged loss of consciousness in individuals with an IQ\>85.

Contacts and Locations

Study Contact

Zenaide MN Quezado, M.D.
CONTACT
(301) 827-1271
zquezado@cc.nih.gov

Principal Investigator

Zenaide MN Quezado, M.D.
PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

  • Zenaide MN Quezado, M.D., PRINCIPAL_INVESTIGATOR, National Institutes of Health Clinical Center (CC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-12-02
Study Completion Date2026-10-06

Study Record Updates

Study Start Date2025-12-02
Study Completion Date2026-10-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Intellectual Disability