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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
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    November 10, 2015
    Last Updated
    August 15, 2017
    Sponsor
    Hospital Sirio-Libanes
    Collaborators
    University of Sao Paulo
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    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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