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临床试验/NCT05478057
NCT05478057尚未招募不适用

Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease

Chang Gung Memorial Hospital0 个研究点目标入组 60 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Change of speech performance from baseline in experiment 1

研究概览

简要总结

Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Experiment 1
  • Inclusion Criteria:
  • right-handed healthy adult volunteers who understand and agree on the informed consent of the study

排除标准

  • pregnancy or possibility of pregnancy
  • history of seizure
  • family history of epilepsy
  • metals in any part of the body.
  • Experiment 2
  • Inclusion Criteria:
  • PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.
  • Exclusion Criteria:
  • the history of stroke, brain lesion, other central nervous system diseases
  • the contraindication of TMS which described above
  • any contraindication of MRI

结局指标

主要结局

Change of speech performance from baseline in experiment 1

时间窗: Baseline ((1) before rTMS), (2) immediately after rTMS

1. sustained phonation of /a/ for as long and steady as possible in one breath 2. fast pa-/ta-/ka- repetition at least nine times in one breath 3. reading a standardized paragraph composed of 80 words as clear and fast as possible

Change of functional connectivity from baseline in experiment 2

时间窗: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS

use rs-fMRI to compare the functional connectivity between PD patients with and without speech disturbance and the changes of connectivity after rTMS over SMA

Change of speech performance from baseline in experiment 2

时间窗: Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS

1. sustained phonation of /a/ for as long and steady as possible in one breath 2. fast pa-/ta-/ka- repetition at least nine times in one breath 3. reading a standardized paragraph composed of 80 words as clear and fast as possible

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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