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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02647372

Enrollment

Registered

2016-01-06

Start date

2012-06-30

Completion date

2018-07-31

Last updated

2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson, deep brain stimulation, globus pallidus, subthalamic nucleus

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.

Interventions

PROCEDURESubthalamic nucleus

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

PROCEDUREGlobus pallidus

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Neurological approach measured by UPDRS scale	through study completion, an average of 2 years	UPDRS scale before surgery

Secondary

Measure	Time frame	Description
Endocrinological approach	through study completion, an average of 2 years	Evaluation of metabolic measures before surgery
Endocrinological approach - BMI	36 months	Evaluation of body mass index before surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026