DRKS00006785已完成未知
Deep Brain Stimulation (DBS) of the Globus pallidus (GP) in Huntington’s disease (HD): A prospective, randomised, controlled, international, multi-centre study - HD-DBS
niversität Düsseldorf0 个研究点目标入组 48 人开始时间: 2014年9月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Clinically symptomatic and genetically confirmed HD (number of CAG repeats = 36)
- •Age =18 years
- •Moderate stage of the disease (UHDRS motor score = 30)
- •Chorea despite best medical treatment (UHDRS chorea subscore = 10)
- •Mattis Dementia Rating Scale = 120 (or > 80% of items testable independently from motor impairment)
- •Patient has stable medication prior six weeks before inclusion
- •Signed informed consent
排除标准
- •Juvenile HD (Westphal variant) or predominant bradykinesia
- •Postural instability with UHDRS retropulsion score > 2
- •Severe comorbidity compromising operability and/or life expectancy and/or quality of life during the trial duration (e.g. cancer with life expectancy < 6 months, NYHA 3 and 4 rising the anaesthetic risk according to the anaesthesiologist)
- •Acute suicidality
- •Acute psychosis (symptoms within previous 6 months)
- •Participation in any interventional clinical trial within 2 months before baseline
- •Cortical atrophy grade 3
- •Patients with risk of coagulopathies and/or increased risk of haemorrhage
- •Patients with an implanted pacemaker or defibrillator
研究者
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