Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prader-Willi Syndrome
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- resting energy expenditure
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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: 6 months
waist circumference; mid-upper arm circumference
Time Frame: 6 months
Secondary Outcomes
- daily food ingestion diary listing(6 months)
- Child Yale-Brown Obsessive Compulsive Scale(6 months)
- Feeding Behaviour Questionnaire(6 months)
- Child Behaviour Checklist(6 months)