NCT02297022

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-11-21
• Last updated: 2015-12-16

Locations

1 site across 1 country: Brazil