Characterization of Nociception Phenotype in Individuals With Intellectual Disability

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Jul 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how people with intellectual disabilities (ID) respond to different types of pain compared to those without ID. The goal is to understand how their brains react to unpleasant sensations, like heat or cold. This research is important because individuals with ID may experience pain differently, and understanding this can help improve their care.

To participate, individuals aged 8 to 30 years with a diagnosis of ID are eligible, along with healthy volunteers who do not have ID and have an IQ above 85. Participants will visit the study site for up to 4 hours (or multiple shorter visits if they have ID) and will undergo a physical exam, answer questions about pain and sensations, and have their brain activity measured using special sensors. They'll feel different stimuli on their bodies and rate how each one feels. It's a unique opportunity to contribute to important research that could enhance our understanding of pain in individuals with intellectual disabilities.

Gender

ALL

Eligibility 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 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.
• 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.