Status:
UNKNOWN
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
15+ years
Phase:
PHASE1
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 implan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02297022
Start Date
October 1 2014
End Date
October 1 2016
Last Update
December 16 2015
Active Locations (1)
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1
HCFUMSP
São Paulo, São Paulo, Brazil, 0543-010