NCT02937688已完成不适用
Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 15
- 主要终点
- Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8).
研究概览
简要总结
To gather data on DBS Therapy effectiveness in different geographic populations.
详细描述
The purpose of this prospective open label post market study of DBS for PD is to gather data on DBS therapy effectiveness as measured by clinician and patient reported health outcomes data through one year of follow-up in different geographic populations.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of DBS for PD consistent with the country specific approved labeling.
- •Levodopa-responsive Parkinson's disease (UPDRS III ≥ 30% improvement on Levodopa challenge test).
- •Symptoms treatable by medications but not adequately controlled with medications (with persistent disabling symptoms, such as motor fluctuations, dyskinesia).
- •At least 22 years old.
- •Screening cranial MRI, performed within 12 months of entry into the study, that is normal or with a non-significant abnormality that does not present any incremental risks or concerns for the patient as a result of the DBS procedure.
- •Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.
排除标准
- •Secondary Parkinson's disease, atypical syndromes.
- •Previous stereotactic functional neurosurgery or ablative therapy (e.g., pallidotomy, subthalamotomy), surgical contraindications related to DBS.
- •Dementia (Mattis Dementia Rating Scale ≤ 130), major depression with suicidal thoughts (Beck Depression Inventory II > 25), acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigator's medical judgment.
- •Electrical or electromagnetic implant (e.g., Cochlear prosthesis, cardiac pacemaker).
- •Surgical or medical contraindications to DBS surgery or therapy (e.g., uncontrolled hypertension, advanced coronary artery disease).
- •Participation in a drug, device, or biologics trial within the preceding 30 days that may confound the study results.
- •Pregnant female.
结局指标
主要结局
Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8).
时间窗: Baseline to 12 months
Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication
时间窗: Baseline to 12 months
次要结局
未报告次要终点
研究者
研究点 (15)
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