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临床试验/NCT03831789
NCT03831789已完成不适用

The Neurophysiological Effects of Bilateral Cerebellar rTMS on Cortical Activity and Swallowing Function

University of Manchester1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
PMEP

研究概览

简要总结

Swallowing function is controlled by two swallowing centres (one on each half of the brain). There is a dominant and non-dominant swallowing centre. Damage to any part of the brain can lead to swallowing problems, for example in strokes. Recovery of the ability to swallow is associated with increased activity (compensation) over the undamaged centre. The cerebellum is an area of the brain involved in the control and modulation of muscle movements. It is found at the back of the skull.

Over the past few years studies have tried to improve swallowing function using techniques to stimulate regions of the brain and encourage compensation. Repetitive transcranial magnetic stimulation (rTMS) is a technique which can temporarily increase or suppress activity over regions of the brain.

This study will use cerebellar rTMS to attempt to increase activity over the cortical swallowing centres. It will also temporarily suppress activity over the dominant swallowing centre (a virtual lesion) before using cerebellar targeted rTMS to attempt to reverse this suppressive electrical and behavioural effect. The investigators aim to compare the effectiveness of rTMS over the two halves of the cerebellum to rTMS over one half of the cerebellum in increasing activity over the swallowing centres and reversing the suppressive effects of low frequency rTMS 'virtual lesion' over the dominant swallowing centre.

详细描述

Summary

To determine if 10 Hertz bilateral cerebellar rTMS is more effective than 10 Hertz unilateral cerebellar rTMS or sham in:

  1. Increasing PMEP amplitude over the pharyngeal cortical area
  2. Reversing focal cortical suppression to the pharyngeal motor cortex induced by a 'virtual lesion'.

This experiment will be performed over six visits to the laboratory.

Experiment Previous studies in our laboratory have shown that focal suppression of the strongest pharyngeal motor representation (1 Hz rTMS for 10 minutes at an intensity of 120% of resting motor threshold) transiently suppresses cortical swallowing activity as measured by PMEP amplitude and function as measured by a swallowing reaction time task, for up to an hour after cessation of rTMS (14, 15). This temporary suppressive effect has been called a cortical 'virtual lesion'. This model has been utilised in several studies (2, 14, 15) as a way of trialling the effects of neurostimulatory interventions in a safe, controlled environment in healthy subjects, before proceeding to patient trials. Studies have also shown that interventions which are capable of reversing the effects of focal cortical suppression more quickly than would ordinarily be the case if the suppressive effects were left to dissipate naturally, are effective in improving post stroke dysphagia (16).

研究设计

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

盲法说明

All participants will be masked as to which of the three study arms they have been allocated. All participants over the course of three visits will either have: unilateral cerebellar rTMS or bilateral cerebellar rTMS. However, as specified earlier the order in which they will receive these interventions will be randomly allocated.

入排标准

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

入选标准

  • •Adults above 18 years of age

排除标准

  • •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

研究组 & 干预措施

Unilateral cerebellar rTMS

Active Comparator

干预措施: Cerebellar targeted rTMS (Device)

Bilateral cerebellar rTMS

Experimental

干预措施: Cerebellar targeted rTMS (Device)

结局指标

主要结局

PMEP

时间窗: Every 15 minutes for an hour after the intervention.

Pharyngeal motor evoked potential amplitude (PMEP) amplitude

Swallowing behaviour

时间窗: Every 15 minutes for an hour after the intervention.

Swallowing accuracy (number of correct swallows on target out of 10 using a swallowing 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

Prof Shaheen Hamdy PhD FRCP

Professor

University of Manchester

研究点 (1)

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