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临床试验/NCT06721533
NCT06721533尚未招募不适用

Cerebellar Metaplasticity in the Swallowing Motor System

University of Manchester0 个研究点目标入组 20 人开始时间: 2024年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Pharyngeal motor evoked potential (PMEP) amplitude

研究概览

简要总结

Dysphagia is common and leads to significant morbidity and mortality within healthcare settings. Current approaches to dysphagia management involve altering the consistency of food and fluids. However, these approaches are not supported by a robust evidence base. Repetitive transcranial magnetic stimulation (rTMS) offers a non-invasive way to manipulate neuroelectric activity within the brain. Within the swallowing motor system, rTMS at a frequency of 5Hertz (Hz) and above is excitatory while 1Hz is suppressive.

Cortical rTMS targeting pharyngeal motor areas can alter brain activity and swallowing behaviour in healthy participants and has been shown to improve post-stroke dysphagia (PSD). Despite this, it has a small seizure risk. Cerebellar rTMS is a newer and safer technique which is more easily targeted and is effective at altering swallowing related brain activity and behaviour. Recent studies have also shown it can improve PSD.

Critically, individual responsiveness to rTMS is variable, potentially reducing its effectiveness. Metaplasticity whereby the brain is preconditioned with a neuroelectric stimulus before the treating stimulus is administered is a potential way of reducing variability. Metaplasticity has recently been shown to improve responses within the swallowing motor system following cortical rTMS. However, to date no cerebellar rTMS study has applied this approach. This is a gap in our understanding which will need to be addressed.

The overarching aim of the study is to develop a less variable and more effective treatment for neurogenic dysphagia. More specifically the study objectives are to establish:

  1. Whether 10Hz Cer-rTMS delivered over hemispheric pharyngeal areas can induce SMS metaplastic changes in healthy participants.
  2. If a cerebellar rTMS metaplastic stimulation protocol can affect swallowing behaviour.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Healthy participants > 18 years of age

排除标准

  • Exclusion criteria will be the presence or a history of:
  • Cardiac pacemaker
  • Previous brain surgery
  • Previous swallowing problems
  • The use of medication which acts on the central nervous system
  • Any implanted metal in the head
  • Pregnancy (self-declared)

结局指标

主要结局

Pharyngeal motor evoked potential (PMEP) amplitude

时间窗: 10 measurements made at baseline, 0 minutes post stimulation, 15 minutes post stimulation, 30 minutes post stimulation, 45 minutes post stimulation and 60 minutes post stimulation

PMEP amplitude measured using single pulse transcranial magnetic stimulation over pharyngeal motor areas of the cortex and cerebellum

Swallowing accuracy

时间窗: 10 measurements made at baseline, 0 minutes post stimulation, 15 minutes post stimulation, 30 minutes post stimulation, 45 minutes post stimulation and 60 minutes post stimulation

Swallowing accuracy measured using a reaction time task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayodele Sasegbon

Dr

University of Manchester

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