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

December 15, 2015 updated by: University of Sao Paulo General Hospital

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

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 0543-010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InternalFunds

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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