Clinical trial NCT02647372: Deep Brain Stimulation for Parkinson's Disease: the Globus Pallidus Internus Versus Subthalamic Nucleus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson
deep brain stimulation
globus pallidus
subthalamic nucleus
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2016-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neurological approach measured by UPDRS scale
timeFrame: through study completion, an average of 2 years
measure: Neurological approach measured by UPDRS scale
timeFrame: 6 months
measure: Neurological approach measured by UPDRS scale
timeFrame: 12 months
measure: Neurological approach measured by UPDRS scale
timeFrame: 24 months
Secondary outcomes:
measure: Endocrinological approach
timeFrame: through study completion, an average of 2 years
measure: Endocrinological approach
timeFrame: 6 months
measure: Endocrinological approach
timeFrame: 12 months
measure: Endocrinological approach
timeFrame: 24 months
measure: Endocrinological approach - BMI
timeFrame: 36 months
measure: Endocrinological approach - BMI
timeFrame: 6 months
measure: Endocrinological approach - BMI
timeFrame: 12 months
measure: Endocrinological approach - BMI
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: