World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 28 December 2015
Main ID:  NCT02297022
Date of registration: 30/10/2014
Prospective Registration: Yes
Primary sponsor: University of Sao Paulo General Hospital
Public title: Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome DBSPW
Scientific title: Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Date of first enrolment: October 2014
Target sample size: 6
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02297022
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Brazil
Contacts
Name:     Ruth Franco
Address: 
Telephone: 55-11 2661-6106
Email: franco-ruth@uol.com.br
Affiliation: 
Name:     Juliana Yamashita
Address: 
Telephone: 551130617672
Email: juliana.yamashita@hc.fm.usp.br
Affiliation: 
Name:     Durval Damiani
Address: 
Telephone:
Email:
Affiliation:  University of Sao Paulo General Hospital
Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Prader-Willi Syndrome
Intervention(s)
Device: Deep Brain Stimulation
Primary Outcome(s)
Body mass index [Time Frame: 6 months]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 3 months]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 6 months]
resting energy expenditure [Time Frame: 6 months]
waist circumference; mid-upper arm circumference [Time Frame: 6 months]
Secondary Outcome(s)
Child Behaviour Checklist [Time Frame: 6 months]
Child Yale-Brown Obsessive Compulsive Scale [Time Frame: 6 months]
daily food ingestion diary listing [Time Frame: 6 months]
Feeding Behaviour Questionnaire [Time Frame: 6 months]
Secondary ID(s)
InternalFunds
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history