Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 24
- 主要终点
- UHDRS-TMS difference
研究概览
简要总结
The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and to show superiority of DBS on motor function in the stimulation group compared to stimulation-off group
详细描述
In this study the efficacy and safety of pallidal Deep Brain Stimulation (DBS) in HD patients shall be investigated and superiority of DBS on motor function in the stimulation group compared to the stimulation-off group shall be shown. This study is a prospective, randomised, double blind, parallel group, sham-controlled, multi-centre trial. Patients in the stimulation group will be stimulated for three months while the stimulator in the sham-group will be turned off for three months. After three months the primary endpoint will be assessed. Afterwards the stimulator will be turned on in all patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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 screening
- •Cortical atrophy grade 3
- •Patients with risk of coagulopathies and/or increased risk of haemorrhage
- •Patients with an implanted pacemaker or defibrillator
- •Pregnancy
- •lactation
结局指标
主要结局
UHDRS-TMS difference
时间窗: 12 weeks postoperatively compared to baseline
Difference between the groups in the UHDRS total motor score (UHDRS-TMS) at 12 weeks postoperatively compared to baseline.
次要结局
- UHDRS-bradykinesia difference(6 months postoperatively compared to baseline)
- HADS-SIS difference(6 months postoperatively compared to baseline)
- SF 36 difference(6 months postoperatively compared to baseline)
- UHDRS-Chorea difference(6 months postoperatively compared to baseline)
- BFMDRS difference(6 months postoperatively compared to baseline)
- Reilmann Battery differences(6 months postoperatively compared to baseline)
- MDRS difference(6 months postoperatively compared to baseline)
- PBA-s difference(6 months postoperatively compared to baseline)
- CGI difference(6 months postoperatively compared to baseline)
- Verbal Fluency Test difference(6 months postoperatively compared to baseline)
- STROOP Test differences(6 months postoperatively compared to baseline)
- SDMT difference(6 months postoperatively compared to baseline)