Subthalamic Deep Brain Stimulation in Patients With Medication-Refractory Primary Cranial-Cervical Dystonia: A Randomised, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of motor and disability scores
研究概览
简要总结
Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin injections.This study is to establish whether subthalamic nucleus neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment. Investigators compared this surgical treatment with sham stimulation in a randomized, controlled clinical trial.
详细描述
In this randomised, sham-controlled trial, investigators will recruit forty patients with primary cranial-cervical dystonia to receive an implanted device for STN-DBS, and participants will be randomly assigned to receive either neurostimulation or sham stimulation for 3 months.The primary end point was the change from baseline to 3 months in the severity of symptoms, according to the Burke-Fahn-Marsden Dystonia Rating Scale. Two masked dystonia experts who unaware of treatment status will assess the severity of dystonia by reviewing standardised videos.Subsequently, all patients will receive open-label neurostimulation; blinded assessment will be repeated after 6 months of active treatment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary cranial-cervical dystonia: blepharospasm combined with dystonia of the lower facial muscles. Cervical muscles can be involved but did not dominate the clinical picture.
- •Medical intractable：including various drugs and local botulinum toxin injections.
- •patients deteriorated in activities of daily living and showed social withdrawal during the course of their disease as they suffered from apparent hyperkinesia of facial muscles and functional blindness secondary to severe blepharospasm.
排除标准
- •All other topographical areas remained unaffected.
- •Secondary causes will be excluded by standard cranial magnetic resonance imaging (MRI) scans.
- •Cognitive impairment, dementia,severe psychiatric diseases as well as higher surgical risks due to comorbidities will also be exclusion criteria.
研究组 & 干预措施
Stimulation Group
Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months.
干预措施: Stimulation (Procedure)
Sham-stimulation Group
Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months.
干预措施: Sham-stimulation (Procedure)
结局指标
主要结局
Change of motor and disability scores
时间窗: Baseline,3 months after surgery, 6 months after active stimulation
Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D)
次要结局
- Depression(Baseline,3 months after surgery,6 months after active stimulation)
- Quality of life(Baseline,3 months after surgery,6 months after active stimulation)
研究者
Kai Zhang
PhD，MD
Beijing Tiantan Hospital