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

Phase 1

• Conditions: Prader-Willi Syndrome
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02297022
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-30
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-21
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation	Patients with Prader-Willi syndrome to receive DBS.

Primary Outcome Measures

Name	Time	Method
resting energy expenditure	6 months
Body mass index	6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	6 months
waist circumference; mid-upper arm circumference	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

HCFUMSP; 🇧🇷 Sao Paulo, SP, Brazil