Prader-Willi Syndrome
Conditions
Keywords
Deep Brain Stimulation, obesity, Prader-Willi syndrome
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDeep Brain Stimulation
Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 15 years or older * Parents able to give informed consent * Diagnosis of Prader-Willi syndrome confirmed by genetic analysis * Refractoriness to medical treatment, defined as a weight loss lower than 10% of the body weight with nutritional, pharmacological or surgical interventions * Severe or morbid obesity * No contra-indications to the surgical procedure
Exclusion criteria
* Cardiovascular disease that might significantly increase the surgical risk * Brain lesions detected clinically or during MRI * Use of cardiac pacemakers/ defibrillators * Clinical conditions that may require the use of MRI in the post-operative period * Patients undergoing chemotherapy or immunosuppressive treatments * Patients unable to return to the hospital at the required intervals * Previous neurosurgical treatments that may increase the risk of DBS surgery * Active medical conditions that may require in-hospital treatment in the nearby future * Previous diagnosis of epilepsy or status epilepticus * Chronic infection * Plan to use diathermy * Metallic implants that might preclude MRI imaging of the brain * Active participation in other experimental studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 months |
| waist circumference; mid-upper arm circumference | 6 months |
| resting energy expenditure | 6 months |
| Body mass index | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| daily food ingestion diary listing | 6 months |
| Child Yale-Brown Obsessive Compulsive Scale | 6 months |
| Child Behaviour Checklist | 6 months |
| Feeding Behaviour Questionnaire | 6 months |
Countries
Brazil
Contacts
Primary ContactJuliana Yamashita
Outcome results
None listed