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

Study Overview
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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.

Official Title
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Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome

Conditions
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Prader-Willi Syndrome

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Patients with Prader-Willi syndrome to receive DBS. | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference; mid-upper arm circumference |  | 6 months | 
| resting energy expenditure |  | 6 months | 
| Body mass index |  | 6 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily food ingestion diary listing |  | 6 months | 
| Child Yale-Brown Obsessive Compulsive Scale |  | 6 months | 
| Child Behaviour Checklist |  | 6 months | 
| Feeding Behaviour Questionnaire |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, obesity, Prader-Willi syndrome