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New treatment option for Intellectual Disability
Official title Characterization of Nociception Phenotype in Individuals With Intellectual Disability
ClinicalTrials.gov ID: NCT05473429
What this study is testing
- What it's testing
- Background: People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 30. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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...
- 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.
See the full eligibility 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
- OR ABAS-3 score above 85.
- Must be fluent in the English Language. Patients -Diagnosis of Intellectual Disability.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.