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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 December 2015 |
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Main ID: |
NCT02297022 |
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Date of registration:
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30/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
DBSPW |
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Scientific title:
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Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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6 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02297022 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Ruth Franco |
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Address:
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Telephone:
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55-11 2661-6106 |
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Email:
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franco-ruth@uol.com.br |
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Affiliation:
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Name:
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Durval Damiani |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo General Hospital |
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Name:
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Juliana Yamashita |
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Address:
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Telephone:
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551130617672 |
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Email:
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juliana.yamashita@hc.fm.usp.br |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Device: Deep Brain Stimulation
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Primary Outcome(s)
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waist circumference; mid-upper arm circumference
[Time Frame: 6 months]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: 3 months]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: 6 months]
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Body mass index
[Time Frame: 6 months]
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resting energy expenditure
[Time Frame: 6 months]
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Secondary Outcome(s)
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Child Behaviour Checklist
[Time Frame: 6 months]
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Child Yale-Brown Obsessive Compulsive Scale
[Time Frame: 6 months]
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Feeding Behaviour Questionnaire
[Time Frame: 6 months]
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daily food ingestion diary listing
[Time Frame: 6 months]
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Secondary ID(s)
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InternalFunds
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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