A Post Market Clinical Evaluation of Deep Brain Stimulation as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- UPDRS motor scores
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.
详细描述
This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.
A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects enrolled in this study must meet the following inclusion criteria:
- •Subject has signed an informed consent.
- •Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
- •Subject is a candidate for surgery.
- •Subject is 18 to 80 years of age.
- •Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
- •Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment.
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- •Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
- •Subject has any condition requiring repeated MRI scans;
- •Subject has any condition requiring diathermy;
- •Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
- •Subject has a history of cranial surgery.
- •Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator.
- •Subject abuses drugs or alcohol.
- •Subject has a history of seizure
- •Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months.
- •Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control.
- •Subject has participated in a drug, device or biological trial within the preceding 30 days.
结局指标
主要结局
UPDRS motor scores
时间窗: [Time Frame: 3 months after device implantation].
Comparison of Parkinson's symptoms as demonstrated by the UPDRS motor scores in the medication 'Off' state at Baseline compared to the medication 'Off' with stimulation "On" 3 months after device implantation
次要结局
- Satisfaction of therapy([through 3, 6 months and 1 year])
- Economic burden of the disease([at baseline and 1 year])
- Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI)([at baseline, 3 month and 1 year])
- Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver([baseline, 3,6 month and 1 year])