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

Primary Purpose

Prader-Willi Syndrome

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring Deep Brain Stimulation, obesity, Prader-Willi syndrome

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HCFUMSPRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation

Arm Description

Patients with Prader-Willi syndrome to receive DBS.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

daily food ingestion diary listing
Child Yale-Brown Obsessive Compulsive Scale
Child Behaviour Checklist
Feeding Behaviour Questionnaire

Full Information

First Posted
October 30, 2014
Last Updated
December 15, 2015
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02297022
Brief Title
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Acronym
DBSPW
Official Title
Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
Keywords
Deep Brain Stimulation, obesity, Prader-Willi syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Patients with Prader-Willi syndrome to receive DBS.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome
Primary Outcome Measure Information:
Title
waist circumference; mid-upper arm circumference
Time Frame
6 months
Title
resting energy expenditure
Time Frame
6 months
Title
Body mass index
Time Frame
6 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
3 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
daily food ingestion diary listing
Time Frame
6 months
Title
Child Yale-Brown Obsessive Compulsive Scale
Time Frame
6 months
Title
Child Behaviour Checklist
Time Frame
6 months
Title
Feeding Behaviour Questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Yamashita
Phone
551130617672
Email
juliana.yamashita@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Durval Damiani
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCFUMSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
0543-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Franco
Phone
55-11 2661-6106
Email
franco-ruth@uol.com.br
First Name & Middle Initial & Last Name & Degree
Erich Fonoff
Phone
55-11 2661-6106
Email
fonoffet@usp.br

12. IPD Sharing Statement

Learn more about this trial

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

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