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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02297022
Recruitment Status : Unknown
Verified November 2014 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : November 21, 2014
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Device: Deep Brain Stimulation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Patients with Prader-Willi syndrome to receive DBS.
Device: Deep Brain Stimulation
Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome




Primary Outcome Measures :
  1. waist circumference; mid−upper arm circumference [ Time Frame: 6 months ]
  2. resting energy expenditure [ Time Frame: 6 months ]
  3. Body mass index [ Time Frame: 6 months ]
  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ]
  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. daily food ingestion diary listing [ Time Frame: 6 months ]
  2. Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 6 months ]
  3. Child Behaviour Checklist [ Time Frame: 6 months ]
  4. Feeding Behaviour Questionnaire [ Time Frame: 6 months ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297022


Contacts
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Contact: Juliana Yamashita 551130617672 juliana.yamashita@hc.fm.usp.br

Locations
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Brazil
HCFUMSP Recruiting
Sao Paulo, SP, Brazil, 0543-010
Contact: Ruth Franco    55-11 2661-6106    franco-ruth@uol.com.br   
Contact: Erich Fonoff    55-11 2661-6106    fonoffet@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Durval Damiani University of Sao Paulo General Hospital

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02297022     History of Changes
Other Study ID Numbers: InternalFunds
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: November 2014

Keywords provided by University of Sao Paulo General Hospital:
Deep Brain Stimulation
obesity
Prader-Willi syndrome

Additional relevant MeSH terms:
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Syndrome
Obesity
Prader-Willi Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn