Clinical trial NCT02297022: Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Official title: Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prader-Willi Syndrome
Keywords: Deep Brain Stimulation
obesity
Prader-Willi syndrome
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 6
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: waist circumference; mid-upper arm circumference
timeFrame: 6 months
measure: resting energy expenditure
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Secondary outcomes:
measure: daily food ingestion diary listing
timeFrame: 6 months
measure: Child Yale-Brown Obsessive Compulsive Scale
timeFrame: 6 months
measure: Child Behaviour Checklist
timeFrame: 6 months
measure: Feeding Behaviour Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: HCFUMSP
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Durval Damiani
role: PRINCIPAL_INVESTIGATOR
References: