Deep Brain Stimulation for Parkinson's Disease: the Globus Pallidus Internus Versus Subthalamic Nucleus
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subthalamic nucleus
Globus pallidus
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson, deep brain stimulation, globus pallidus, subthalamic nucleus
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Endocrinological approach
Neurological approach
Arm 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.
Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be neurological evaluation including UPDRS scale.
Outcomes
Primary Outcome Measures
Neurological approach measured by UPDRS scale
UPDRS scale before surgery
Neurological approach measured by UPDRS scale
UPDRS scale 6 months after surgery
Neurological approach measured by UPDRS scale
UPDRS scale 12 months after surgery
Neurological approach measured by UPDRS scale
UPDRS scale 24 months after surgery
Secondary Outcome Measures
Endocrinological approach
Evaluation of metabolic measures before surgery
Endocrinological approach
Evaluation of metabolic measures 6 months after surgery
Endocrinological approach
Evaluation of metabolic measures 12 months after surgery
Endocrinological approach
Evaluation of metabolic measures 24 months after surgery
Endocrinological approach - BMI
Evaluation of body mass index before surgery
Endocrinological approach - BMI
Evaluation of body mass index 6 months after surgery
Endocrinological approach - BMI
Evaluation of body mass index12 months after surgery
Endocrinological approach - BMI
Evaluation of body mass index 24 months after surgery
Full Information
NCT ID
NCT02647372
First Posted
November 10, 2015
Last Updated
August 15, 2017
Sponsor
Hospital Sirio-Libanes
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02647372
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
Collaborators
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson, deep brain stimulation, globus pallidus, subthalamic nucleus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endocrinological approach
Arm Type
Experimental
Arm 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.
Arm Title
Neurological approach
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Subthalamic nucleus
Intervention Description
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
Intervention Type
Procedure
Intervention Name(s)
Globus pallidus
Intervention Description
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus
Primary Outcome Measure Information:
Title
Neurological approach measured by UPDRS scale
Description
UPDRS scale before surgery
Time Frame
through study completion, an average of 2 years
Title
Neurological approach measured by UPDRS scale
Description
UPDRS scale 6 months after surgery
Time Frame
6 months
Title
Neurological approach measured by UPDRS scale
Description
UPDRS scale 12 months after surgery
Time Frame
12 months
Title
Neurological approach measured by UPDRS scale
Description
UPDRS scale 24 months after surgery
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Endocrinological approach
Description
Evaluation of metabolic measures before surgery
Time Frame
through study completion, an average of 2 years
Title
Endocrinological approach
Description
Evaluation of metabolic measures 6 months after surgery
Time Frame
6 months
Title
Endocrinological approach
Description
Evaluation of metabolic measures 12 months after surgery
Time Frame
12 months
Title
Endocrinological approach
Description
Evaluation of metabolic measures 24 months after surgery
Time Frame
24 months
Title
Endocrinological approach - BMI
Description
Evaluation of body mass index before surgery
Time Frame
36 months
Title
Endocrinological approach - BMI
Description
Evaluation of body mass index 6 months after surgery
Time Frame
6 months
Title
Endocrinological approach - BMI
Description
Evaluation of body mass index12 months after surgery
Time Frame
12 months
Title
Endocrinological approach - BMI
Description
Evaluation of body mass index 24 months after surgery
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Deep Brain Stimulation for Parkinson's Disease: the Globus Pallidus Internus Versus Subthalamic Nucleus
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