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

NCT ID: NCT02297022

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Prader-Willi Syndrome

Keywords

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Deep Brain Stimulation obesity Prader-Willi syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation

Patients with Prader-Willi syndrome to receive DBS.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome

Interventions

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Deep Brain Stimulation

Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome

Intervention Type DEVICE

Eligibility 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Durval Damiani

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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HCFUMSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Juliana Yamashita

Role: CONTACT

Phone: 551130617672

Email: [email protected]

Facility Contacts

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Ruth Franco

Role: primary

Erich Fonoff

Role: backup

Other Identifiers

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InternalFunds

Identifier Type: -

Identifier Source: org_study_id