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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Subthalamic nucleus
* Procedure: Globus pallidus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocrinological approach<br>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. | Procedure: Subthalamic nucleus<br>* Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus<br>Procedure: Globus pallidus<br>* Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus<br>|
| Experimental: Neurological approach<br>Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be neurological evaluation including UPDRS scale. | Procedure: Subthalamic nucleus<br>* Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus<br>Procedure: Globus pallidus<br>* Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological approach measured by UPDRS scale | UPDRS scale before surgery | through study completion, an average of 2 years | 
| Neurological approach measured by UPDRS scale | UPDRS scale 6 months after surgery | 6 months | 
| Neurological approach measured by UPDRS scale | UPDRS scale 12 months after surgery | 12 months | 
| Neurological approach measured by UPDRS scale | UPDRS scale 24 months after surgery | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrinological approach | Evaluation of metabolic measures before surgery | through study completion, an average of 2 years | 
| Endocrinological approach | Evaluation of metabolic measures 6 months after surgery | 6 months | 
| Endocrinological approach | Evaluation of metabolic measures 12 months after surgery | 12 months | 
| Endocrinological approach | Evaluation of metabolic measures 24 months after surgery | 24 months | 
| Endocrinological approach - BMI | Evaluation of body mass index before surgery | 36 months | 
| Endocrinological approach - BMI | Evaluation of body mass index 6 months after surgery | 6 months | 
| Endocrinological approach - BMI | Evaluation of body mass index12 months after surgery | 12 months | 
| Endocrinological approach - BMI | Evaluation of body mass index 24 months after surgery | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinson, deep brain stimulation, globus pallidus, subthalamic nucleus