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

Prader-Willi Syndrome Clinical Trial

— DBSPW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02297022
• Other study ID #: InternalFunds
• Status: Recruiting
• Phase: Phase 1
• First received: October 30, 2014
• Last updated: December 15, 2015
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2014
• Source: University of Sao Paulo General Hospital
• Contact: Juliana Yamashita
• Phone: 551130617672
• Email: juliana.yamashita[@]hc.fm.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	HCFUMSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	waist circumference; mid-upper arm circumference		6 months	No
Primary	resting energy expenditure		6 months	No
Primary	Body mass index		6 months	No
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 months	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		6 months	Yes
Secondary	daily food ingestion diary listing		6 months	No
Secondary	Child Yale-Brown Obsessive Compulsive Scale		6 months	No
Secondary	Child Behaviour Checklist		6 months	No
Secondary	Feeding Behaviour Questionnaire		6 months	No