Inhibitory rTMS Applied on Laryngeal Motor Cortex in Wilson's Disease Patients With Dysarthria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Improvement of the Clinical Assessment Battery for Dysarthria intelligibility score
研究概览
简要总结
Wilson disease is a hereditary hepatic and neurological disease associated with copper accumulation. Neurological symptoms are of extra-pyramidal, cerebellar and dystonic origin. Dysarthria is one of the debilitating symptoms of Wilson disease poorly responsive to pharmacological treatment. The most common form is a dystonic hyperkinetic Dysarthria.
Pathophysiology of dystonia is still not elucidated. Motor cortex hyperexcitability has been demonstrated in various forms of dystonia. Furthermore, rTMS inhibitory applied over motor cortex has been shown to transitory reduce dystonic symptoms in various forms of dystonia.
In the present study, we investigate the effect of a single 1Hz 20-minutes inhibitory rTMS session applied over the motor laryngeal cortex on dyasarthria is the main kinetic dysarthria has been shown to be associated with inhibition of laryngeal motor cortex in Parkinson disease.
详细描述
A consecutive series of Wilson disease patients with dystonic hyperkinetic dysarthria will be prospectively recruited.
Patients will receive 3 days apart to two rTMS sessions.
rTMS procedures will be performed with a figure of eight coiled. A single 20-minutes 1 Hz biphasic stimulation (1200 pulses) session will be applied over the laryngeal motor cortex. A brain imaging positioning device will be used during all the procedure A second stimulation session will be performed 3 days apart.
Patients will be centrally randomized to receive first either the active stimulation (80% of the resting motor threshold) or the sham stimulation (using a visually identical coil to reproduce the click sound and the scalp sensation of the active coil).
A TMS evaluation of cortical silent period over the left motor cortex will be performed before the first rTMS session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients are centrally randomized to receive first either the active stimulation (80% of the resting motor threshold) or the sham stimulation (using a visually identical coil to reproduce the click sound and the scalp sensation of the active coil). The operator is unblided. The evaluator is blinded.
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
- •Conseting adult patients with social insurance
- •Wilson disease with dystonic hyperkinetic dysarthria
- •Stable pharmacological therapy n the last 6 monts
- •Brain MRI in the previous 6 months, without additional brain lesion
- •Patients that did not receive botulinium toxin in the previous 4 months
排除标准
- •Incapacitated adult
- •Previous mdedical history of epilepsia
- •Pregnancy or breastfeeding
- •Brain lesion outside basal ganglia on brain MRI
- •Patient consider by the investigator not able to sustain an 30 minutes rTMS session without moving
- •Vocal chord lesion
- •Previous history of laryngeal surgery
- •rTMS contra indication
结局指标
主要结局
Improvement of the Clinical Assessment Battery for Dysarthria intelligibility score
时间窗: within 30 minutes after stimulation session at Day1 and Day4
Improvement of the Clinical Assessment Battery for Dysarthria intelligibility score with active stimulation in comparison to sham stimulation
次要结局
- Improvement of the Clinical Assessment Battery for Dysarthria intelligibility sub-scores(within 30 minutes after stimulation session at Day1 and Day4)
- the "A" phonation time(within 30 minutes after stimulation session at Day1 and Day4)
- Improvement of the diadococinesia(within 30 minutes after stimulation session at Day1 and Day4)
- Improvement of text reading(within 30 minutes after stimulation session at Day1 and Day4)
- Improvement of bucco-linguo-facial motricity(within 30 minutes after stimulation session at Day1 and Day4)
- Correlation between clinical Assessment Battery for Dysarthria intelligibility score and UWDRS, and MRI brain atrophy and basal ganglia lesions(at Day1 and Day4)
- Improvement bucco-linguo-facial motricity(within 30 minutes after stimulation session at Day1 and Day4)
- Side effects of rTMS(within few hours after stimulation session at Day1 and Day4)