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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02647372
• Other study ID #: HSL 2012/12
• Status: Active, not recruiting
• Phase: N/A
• First received: November 10, 2015
• Last updated: August 15, 2017
• Start date: June 2012
• Est. completion date: July 2018

Study information

• Verified date: August 2017
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Subthalamic nucleus
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
• Globus pallidus
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes	University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological approach measured by UPDRS scale	UPDRS scale before surgery	through study completion, an average of 2 years
Primary	Neurological approach measured by UPDRS scale	UPDRS scale 6 months after surgery	6 months
Primary	Neurological approach measured by UPDRS scale	UPDRS scale 12 months after surgery	12 months
Primary	Neurological approach measured by UPDRS scale	UPDRS scale 24 months after surgery	24 months
Secondary	Endocrinological approach	Evaluation of metabolic measures before surgery	through study completion, an average of 2 years
Secondary	Endocrinological approach	Evaluation of metabolic measures 6 months after surgery	6 months
Secondary	Endocrinological approach	Evaluation of metabolic measures 12 months after surgery	12 months
Secondary	Endocrinological approach	Evaluation of metabolic measures 24 months after surgery	24 months
Secondary	Endocrinological approach - BMI	Evaluation of body mass index before surgery	36 months
Secondary	Endocrinological approach - BMI	Evaluation of body mass index 6 months after surgery	6 months
Secondary	Endocrinological approach - BMI	Evaluation of body mass index12 months after surgery	12 months
Secondary	Endocrinological approach - BMI	Evaluation of body mass index 24 months after surgery	24 months