Understanding pain responses in individuals with intellectual disability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 85 OR General Adaptive Composite ABAS-3 score above 85
* Must be fluent in the English Language.

Healthy Children

* IQ above 85 OR ABAS-3 score 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Leopard: using multi-omics to boost genetic diagnosis for neurodevelopmental disorders

  This study tests a multi-omics approach to find genetic explanations for neurodevelopmental disorders in people with moderate-to-severe intellectual disability.

  Recruiting Istituto Giannina Gaslini · Genova · NCT07884227

• Regulating Together for Emotion Dysregulation in ASD and Intellectual Disability (group therapy)

  This study tests a group therapy program for kids with autism and co-occurring intellectual disability to help them manage irritability and aggression, with sessions for both children and their caregivers.

  Recruiting Children's Mercy Hospital Kansas City · Kansas City, Missouri · NCT07624448

• Digital games to improve visual memory and thinking skills in young adults with intellectual disability

  This trial will test whether twice-weekly MentalUP digital game sessions help 18–35-year-olds with mild to moderate intellectual disability improve visual memory and cognitive skills.

  Recruiting Koç University · Istanbul, Türkiye · NCT07476092

• Using preferred communication tools to reduce challenging behavior

  This project will test whether using a person's favored communication tool (for example a touch talker or picture cards) helps keep behavior improvements and prevents relapse in people with intellectual or developmental disabilities who have little or no verbal speech.

  Recruiting at 2 sites University of Georgia · Athens, Georgia and 1 other locations · NCT07278544

• Deutetrabenazine for Tardive Dyskinesia in IDD

  This study tests whether deutetrabenazine helps reduce tardive dyskinesia in people with intellectual and developmental disabilities who have not previously received this treatment.

  Recruiting Phase 4 University Hospitals Cleveland Medical Center · Cleveland, Ohio · NCT06997198

• Theta Burst Stimulation for Emotion Regulation in Autism With Minimal Verbal Ability or Intellectual Disability

  This trial tests whether intermittent theta burst stimulation to the left prefrontal cortex can help improve emotion regulation in people with autism who are minimally verbal or have an intellectual disability.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT06974838

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.