The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment.
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Patients will be implanted with hypothalamic DBS electrodes. Calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. Side effects will be monitored at 1, 3, 6 and 12 months following surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome
HCFUMSP
São Paulo, São Paulo, Brazil
RECRUITINGwaist circumference; mid-upper arm circumference
Time frame: 6 months
resting energy expenditure
Time frame: 6 months
Body mass index
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months
daily food ingestion diary listing
Time frame: 6 months
Child Yale-Brown Obsessive Compulsive Scale
Time frame: 6 months
Child Behaviour Checklist
Time frame: 6 months
Feeding Behaviour Questionnaire
Time frame: 6 months
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