Understanding pain responses in individuals with intellectual disability
Characterization of the Nociception Phenotype in Individuals With Intellectual Disability
This study tests how people with intellectual disabilities experience pain compared to healthy individuals by looking at their brain activity and physical reactions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 8 Years to 30 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05473429 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how individuals with intellectual disability (ID) respond to painful and non-painful stimuli compared to healthy individuals. Participants aged 8 to 30 will undergo a series of tests, including brain imaging techniques like EEG and fNIRS, to measure brain activity in response to various stimuli. The study will also explore the relationship between brain responses and physiological reactions, such as heart rate and skin response. Both individuals with ID and healthy controls will be involved to provide a comprehensive comparison.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 8 to 30 years diagnosed with intellectual disability, as well as healthy volunteers within the same age range.
Not a fit: Patients who do not meet the age requirement or do not have a diagnosis of intellectual disability may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and management of pain in individuals with intellectual disabilities.
How similar studies have performed: While there is limited research specifically on pain in individuals with intellectual disabilities, studies using similar brain imaging techniques have shown promise in understanding pain responses in other populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Zenaide MN Quezado, M.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Zenaide MN Quezado, M.D.
- Email: zquezado@cc.nih.gov
- Phone: (301) 827-1271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.