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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Neurological approach measured by UPDRS scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Subthalamic nucleus (Procedure)
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.
干预措施: Globus pallidus (Procedure)
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.
干预措施: Subthalamic nucleus (Procedure)
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.
干预措施: Globus pallidus (Procedure)
结局指标
主要结局
Neurological approach measured by UPDRS scale
时间窗: 24 months
UPDRS scale 24 months after surgery
次要结局
- Endocrinological approach(24 months)
- Endocrinological approach - BMI(24 months)
研究者
Erich Fonoff
MD, PhD
Hospital Sirio-Libanes