Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia: An Exploratory Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The associations between clinical (e.g. dystonic tremor versus tremor associated with dystonia, jerkiness, dominant tremor pattern, sensory trick), electrophysiological (e.g. frequency-width at half-width power, intermuscular coherence), ultrasonographic (e.g. echogenicity, muscle thickness, tremulous muscles) and (functional) magnetic resonance imaging tremor characteristics (e.g. ratio of tremor-related activity in the basal ganglia versus cerebello-thalamo-cortical circuit)
研究概览
简要总结
To explore the associations between clinical, electrophysiological, ultrasonographic and (functional) magnetic resonance imaging tremor characteristics and botulinum neurotoxin efficacy in dystonic tremor syndrome of the upper extremity.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of dystonic tremor or tremor associated with dystonia according to the 2018 consensus statement on the classification of tremors
- •Tremor of one or both upper extremities
- •Starting botulinum neurotoxin injections as part of normal clinical practice
- •Age ≥ 18 years
排除标准
- •Acquired aetiology of dystonic tremor syndrome
- •Pregnancy, trying to conceive and breastfeeding
- •Insufficient knowledge of the Dutch or English language
- •Previous botulinum neurotoxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions
- •In case of previous botulinum neurotoxin treatment of the to be treated upper extremity for ≤3 consecutive sessions: the last botulinum neurotoxin injections ≤ 6 months before study enrolment
- •Unstable dose medications for dystonia and tremor ≤ 1 month before study enrolment
- •Deep brain stimulation implantation ≤ 6 months before study enrolment
- •Unstable deep brain stimulation variables ≤ 1 month before study enrolment
- •Comorbidity interfering with study participation
- •Known hypersensitivity for components of Dysport
- •Infection at the upper extremity
结局指标
主要结局
The associations between clinical (e.g. dystonic tremor versus tremor associated with dystonia, jerkiness, dominant tremor pattern, sensory trick), electrophysiological (e.g. frequency-width at half-width power, intermuscular coherence), ultrasonographic (e.g. echogenicity, muscle thickness, tremulous muscles) and (functional) magnetic resonance imaging tremor characteristics (e.g. ratio of tremor-related activity in the basal ganglia versus cerebello-thalamo-cortical circuit)
The associations between clinical (e.g. dystonic tremor versus tremor associated with dystonia, jerkiness, dominant tremor pattern, sensory trick), electrophysiological (e.g. frequency-width at half-width power, intermuscular coherence), ultrasonographic (e.g. echogenicity, muscle thickness, tremulous muscles) and (functional) magnetic resonance imaging tremor characteristics (e.g. ratio of tremor-related activity in the basal ganglia versus cerebello-thalamo-cortical circuit)
次要结局
- The clinical, electrophysiological, ultrasonographic and (functional) magnetic resonance imaging differences between dystonic tremor and tremor associated with dystonia at baseline (e.g. jerkiness, dominant tremor pattern, frequency-width at half-width power, intermuscular coherence, tremulous muscles, ratio of tremor-related activity in the basal ganglia versus cerebello-thalamo-cortical circuit).
- The agreement between a clinical assessment, polymyography and muscle ultrasound on muscle selection
研究者
Anke Snijders
Scientific
Stichting Radboud universitair medisch centrum