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

August 15, 2017 updated by: Erich Fonoff, Hospital Sirio-Libanes

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Subthalamic nucleus
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
Procedure: Globus pallidus
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus
Experimental: 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.
Procedure: Subthalamic nucleus
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
Procedure: Globus pallidus
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Collaborators

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL 2012/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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