Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria and Brain Plasticity in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
研究概览
简要总结
Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only partially to pharmacotherapy and surgery. The investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal gyrus, brain area known to be engaged in the feedback control of voiced speech. The project results will allow for the identification of potential therapeutic effects of rTMS as a tool that could contribute to the speech therapy of HD in PD patients. The results will also enhance our understanding of brain mechanisms underlying specific long-term effects of rTMS.
详细描述
A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation. An MRI protocol consisting of T1, EPI BOLD, and DTI (diffusion tensor imaging) sequences and speech evaluation (acoustic signal processing and 3F test) will be performed prior to and after 10 days of rTMS and then repeated after 4, 8 and 12 weeks.
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
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with clinically established PD (Postuma et al. 2016)
排除标准
- •psychiatric disorders, including major depression, hallucinations
- •any MRI-incompatible metal in the body
- •lack of cooperation
- •presence of dementia
研究组 & 干预措施
PD patients with real rTMS
Patients will receive real rTMS in a two weeks long sessions (10 sessions).
干预措施: Transcranial magnetic stimulation- real rTMS (Device)
PD patients with sham rTMS
Patients will receive sham rTMS in a two weeks long sessions (10 sessions).
干预措施: Transcranial magnetic stimulation- sham rTMS (Device)
结局指标
主要结局
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
时间窗: On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.
The 3F Test Dysarthric Profile enables clinicians to characterize a wide range of signs and symptoms of dysarthria. The minimum value of this scale is 0 (anarthria), the maximum value is 90 (no disorder). Higher scores of this scale mean better outcome. This test will be administrated by speech pathologist.
次要结局
- Resting state(On the beginning of the study, after completion of two weeks stimulation, 4,8 and 12 weeks after completion of stimulation sessions.)