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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.
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
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
Name:     Ruth Franco
Telephone: 55-11 2661-6106
Name:     Juliana Yamashita
Telephone: 551130617672
Name:     Durval Damiani
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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results available:
Date Posted:
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