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

NCT ID: NCT02647372

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-07-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endocrinological approach

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.

Group Type: EXPERIMENTAL

Subthalamic nucleus

Intervention Type: PROCEDURE

Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus

Globus pallidus

Intervention Type: PROCEDURE

Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

Neurological approach

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

Group Type: EXPERIMENTAL

Subthalamic nucleus

Intervention Type: PROCEDURE

Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus

Globus pallidus

Intervention Type: PROCEDURE

Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

Interventions

Subthalamic nucleus

Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus

Intervention Type: PROCEDURE

Globus pallidus

Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Erich Fonoff

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HSL 2012/12

Identifier Type: -

Identifier Source: org_study_id