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Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome — DBSPW  

Prader-Willi Syndrome Clinical Trial

Official title:
Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02297022
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Juliana Yamashita
Phone 551130617672
Email juliana.yamashita@hc.fm.usp.br
Status Recruiting
Phase Phase 1
Start date October 2014
Completion date October 2016
View Details
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