Deep Brain Stimulation for Parkinson's Disease: the Globus Pallidus Internus Versus Subthalamic Nucleus

Hospital Sirio-Libanes

Status: Unknown

Conditions: Parkinson Disease

Treatments: Procedure: Globus pallidus; Procedure: Subthalamic nucleus

Study type: Interventional

Funder types: Other

Identifiers

NCT02647372

HSL 2012/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Endocrinological approach

Experimental group

Description:

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.

Treatment:

Procedure: Subthalamic nucleus

Procedure: Globus pallidus

Neurological approach

Experimental group

Description:

Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be neurological evaluation including UPDRS scale.

Treatment:

Procedure: Subthalamic nucleus

Procedure: Globus pallidus