Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatments subthalamic nucleus, globus pallidus
Sponsor Hospital Sirio-Libanes
Collaborator University of Sao Paulo
Start date June 2012
End date July 2017
Trial size 30 participants
Trial identifier NCT02647372, HSL 2012/12

Summary

This study provides an evaluation of 30 patients in 3 years, from the Unified Health System (SUS) irrespective of region of the country, signed with clinical Parkinson's disease in its intermediate stage and that the drug therapy is limited by side effects or beneficial effects provided by prior medication no longer be obtained even at high doses and have therefore the indication for treatment with deep brain stimulation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be endocrinological evaluation including metabolic measures, calorimetric parameters.
subthalamic nucleus
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
globus pallidus
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus
(Experimental)
Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be neurological evaluation including UPDRS scale.
subthalamic nucleus
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
globus pallidus
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

Primary Outcomes

Measure
Neurological approach measured by UPDRS scale
time frame: through study completion, an average of 2 years
Neurological approach measured by UPDRS scale
time frame: 6 months
Neurological approach measured by UPDRS scale
time frame: 12 months
Neurological approach measured by UPDRS scale
time frame: 24 months

Secondary Outcomes

Measure
Endocrinological approach
time frame: through study completion, an average of 2 years
Endocrinological approach
time frame: 6 months
Endocrinological approach
time frame: 12 months
Endocrinological approach
time frame: 24 months
Endocrinological approach - BMI
time frame: 36 months
Endocrinological approach - BMI
time frame: 6 months
Endocrinological approach - BMI
time frame: 12 months
Endocrinological approach - BMI
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with a clinical diagnosis of idiopathic Parkinson's disease according to the international criteria that have not responded adequately to treatment with medication or who have complications related to prolonged use of L-dopa. - Patients who may be in the anesthetized or local or general anesthesia does not incur higher than expected risk in the general population. - Patients intellectually able to understand and sign the consent form. - Patients with hematological, metabolic and normal coagulation. Exclusion Criteria: - Age below 18 years - Impossibility to consent to participate in the study. - Patients during treatment with anti-coagulants or anti-platelet agents. - Patients with anatomical abnormalities that preclude access to the implantation of electrodes (eg cranial tumors or intracranial or cysts). - Patients with uncontrolled infection or other medical conditions pre-existing non-controlled (eg decompensated diabetes, hypertension, heart disease or symptomatic air). - History of primary or secondary myocardial ischemia, congestive heart failure, cardiac arrhythmia or bundle branch block refractory to treatment. - Concomitant treatment with other experimental drugs. - Pregnant or lactating.

Additional Information

Official title Deep Brain Stimulation for the Treatment of Parkinson's Disease: Comparative Analysis of Clinical Effect of Stimulation of the Globus Pallidus Internus and Subthalamic Nucleus
Description The aim of this retrospective study is to compare motor and non-motor (olfactory, pain, cognition and metabolism) symptoms of the effects of deep brain stimulation target to the nucleus globus pallidus versus the subthalamic nucleus in patients with Parkinson´s disease.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Hospital Sirio-Libanes.