Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-30
SponsorNational Institutes of Health Clinical Center (CC)

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TSA2 Thermosensory Stimulator

Treatment groups

215 Participants
are divided into 2 treatment groups