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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prader-Willi Syndrome
• Intervention / Treatment: Device: Deep Brain Stimulation

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 Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 0543-010
      • Recruiting
      • HCFUMSP
      • Contact: Ruth Franco; Phone Number: 55-11 2661-6106; Email: franco-ruth@uol.com.br
      • Contact: Erich Fonoff; Phone Number: 55-11 2661-6106; Email: fonoffet@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Brain Stimulation; Patients with Prader-Willi syndrome to receive DBS.	Device: Deep Brain Stimulation; Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body mass index	6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	6 months
waist circumference; mid-upper arm circumference	6 months
resting energy expenditure	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
daily food ingestion diary listing	6 months
Child Yale-Brown Obsessive Compulsive Scale	6 months
Child Behaviour Checklist	6 months
Feeding Behaviour Questionnaire	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Durval Damiani, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: obesity; Prader-Willi syndrome; Deep Brain Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Obesity; Prader-Willi Syndrome
• Other Study ID Numbers: InternalFunds