NCT02297022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 16, 2015

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

October 30, 2014

Last Update Submit

December 15, 2015

Conditions

Prader-Willi Syndrome

Keywords

Deep Brain StimulationobesityPrader-Willi syndrome

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Patients with Prader-Willi syndrome to receive DBS.

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

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

Deep Brain Stimulation

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCFUMSP

São Paulo, São Paulo, 0543-010, Brazil

RECRUITING

MeSH Terms

Conditions

Prader-Willi SyndromeObesity

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Durval Damiani

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Yamashita

CONTACT

551130617672juliana.yamashita@hc.fm.usp.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 21, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 16, 2015

Record last verified: 2014-11

Locations

BR(1)