Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- immediate and significant improvement in writing
研究概览
简要总结
Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. The neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily life activities such as writing, which is particularly disabling, since writing is the only mean of communication in these patients with significant slurred speech. Treatment is limited and only partially effective.
Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown inhibiting properties when applied over the cortex. Since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right dystonic hand, assessed immediately at the end of the session.
详细描述
This study investigates the handwriting performance of an homogeneous cohort of patients with Wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial magnetic stimulation (rTMS). Fifteen patients with focal right hand dystonia will receive randomly either active or sham rTMS (1 Hz) to the left somatosensory cortex (SSC) in one single 20 minutes session. Handwriting performance will be measured immediately after this unique session (Visual analogic scale of subjective discomfort in writing, DPRE and WCRS scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24 hours before the session. Three days later, the patient will receive the other session (sham rTMS or active rTMS) and the same parameters will be evaluated.
This is a single-center, randomized, crossover, prospective, clinical and double-blind study (the rTMS session is performed by the neurophysiologist, but the patient and the neurologist who will perform the handwriting evaluation are blind to the 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
- Triple (Participant, Care Provider, 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
- •Wilson disease with focal right hand dystonia
- •No modification of medical treatment for 6 months
- •No botulinum toxin administration within the past four months
- •Right handed
- •Focal right hand dystonia
- •Cerebral Magnetic Resonance performed the last 6 months with no other lesion than met in Wilson disease
- •Insurance policy holder
- •Informed consent
排除标准
- •Pregnant woman
- •Guardianship procedure
- •Seizure history
- •Other cerebral lesions on cerebral MRI than met in Wilson Disease
- •Unable to stay quiet for 30 minutes
- •Handwriting impossible
- •Contra-indications to repetitive Transcranial Magnetic Stimulation
结局指标
主要结局
immediate and significant improvement in writing
时间窗: up to 1 week
Improvement of handwriting performance immediately after one single 20 minutes session of inhibitory (1 Hz) repetitive transcranial magnetic stimulation over the left somatosensory cortex. quantitative test score of writing WCRS Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.
次要结局
- significant improvement in writing(up to 1 week)
- improvement of dystonia on the scale WDRS(up to 1 week)
- correlation between the scores and the other parameters of disease severity(up to 1 week)