The effect of intranasal insulin on development and behaviour of children with Phelan-McDermid syndrome.Dutch: Het effect van insuline neusspray op ontwikkeling en gedrag van kinderen met het Phelan-McDermid syndroom.
- Conditions
- Phelan-McDermid syndrome, 22q13.3 deletion syndrome, insulin, intranasal, development, behaviour.Dutch: Phelan-McDermid syndroom, 22q13.3 deletie syndroom, insuline, intransasaal, ontwikkeling, gedrag.
- Registration Number
- NL-OMON24236
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
On the moment of registration, the study has yet to begin. Therefore there currently are no publications concerning this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Age between 12 months and 18 years 0 months old at 1-1-2013;
2. Proven SHANK3 deletion by array-comparative genomic hybridization (array-CGH);
Exclusion Criteria
1. A contra-indication for the use of intranasal application (e.g. anatomical obstruction);
2. Severe perinatal brain damage (e.g. asphyxia, haemorrhage, infection);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Developmental pace, calculated as the difference in developmental age equivalent between two assessments divided by the difference in calendar age in months at the time of these assessments (typically 6 months).
- Secondary Outcome Measures
Name Time Method Behaviour, improvement of behaviour represented by the increase in test scores between assessment (typically 6 months).