To compare discrimination ability for touch and temperature between subjects with Down*s syndrome and healthy controls. To compare thermal pain thresholds between subjects with Down*s syndrome and healthy controls
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Sensory testing part 1: Correct sensations of cold, warmth, light touch, and
sharpness.
- Sensory testing part 2: Correct sensations of touch (Neuropen) and warm /
cold (Rolltemp)
- Sensory testing part 3: Detection threshold (touch) by Von Frey hairs.
Detection and pain thresholds (warm and cold) in degrees Celsius (Thermal
Sensory Analyzer).
Secondary outcome
Not applicable
Background summary
Down*s syndrome is the number one cause of congenital intellectual disability
in the Netherlands: each year about 275 children are born with Down*s syndrome.
It is important to study the pain experience and pain expression of those
children. Pain assessment and -treatment in intellectually disabled children
can perhaps be more effective and more tailor-made, when the transmission of
nociceptive stimuli in those children is better understood. Quantitative
sensory testing, with the Thermal Sensory Analyzer, proved promising in
children and adults. However, there is still little experience with this test
in intellectually disabled children such as children with Down*s syndrome.
Study objective
To compare discrimination ability for touch and temperature between subjects
with Down*s syndrome and healthy controls.
To compare thermal pain thresholds between subjects with Down*s syndrome and
healthy controls
Study design
Observational study
Study burden and risks
The subjects will be tested at home (duration 2 hours). The measurements are
risk free with minimal burden. One saliva sample of 2 mL will be collected.
Parents are asked to complete three questionnaires. Moreover, this project
serves as a starting point for the evaluation of pain in other groups of
intellectually disabled individuals.
Dr. Molewaterplein 60
3015 GJ Rotterdam
NL
Dr. Molewaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Down*s syndrome group:
- Confirmed trisomy 21
- Age 8 to 30 years ;Control group:
- Sibling of participant with Down*s syndrome
- Age 8 to 30 years
Exclusion criteria
- Developmental age lower than 5 years
- Insufficient understanding of the concepts of warm and cold sensation
- Diagnosis of migraine
- Treatment with antidepressants
- Treatment with anticonvulsants
- Treatment with analgesics <24 hours before study visit
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31714.078.10 |