Characterization of Nociception Phenotype in Individuals With Intellectual Disability

NCT05473429 | Recruiting

• 2 other identifiers: 10000417000417-CC
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Provide quantitative measure of pain perception

  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

  End of study

Secondary Outcomes (1)

• Provides measure of pain among non-communicating individuals

  End of study

Study Arms (2)

1/ID patients

EXPERIMENTAL

ID Patients

Device: TSA2 Thermosensory Stimulator

2/Healthy controls

ACTIVE COMPARATOR

Healthy controls

Device: TSA2 Thermosensory Stimulator

Interventions

TSA2 Thermosensory Stimulator DEVICE

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.

1/ID patients; 2/Healthy controls

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 above 85.
• Must be fluent in the English Language.
• Healthy Children
• IQ above 85.
• Must be fluent in the English Language.
• Patients
• Diagnosis of Intellectual Disability.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Zenaide MN Quezado, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zenaide MN Quezado, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: March 27, 2026
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04-06

Locations

US (1)