Effect of Preconditioning of Human Pharyngeal Motor Cortex by Low Frequency Repetitive Transcranial Magnetic Stimulation on Enhancing Cortical Excitability Induced by Pharyngeal Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percentage change of the amplitude of PMEP after intervention
研究概览
简要总结
The goal of this interventional study is to optimize the excitatory brain effects of combined neuromodulatory therapies on swallowing areas of the brain. The main question it aims to answer is:
Does preconditioning with 1 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) delivered over hemispheric pharyngeal areas enhance the activating effects of pharyngeal electrical stimulation (PES) on cortical excitability?
Participants will:
- Visit the department three times, with at least a one-week gap between visits.
- Undergo baseline measurements for Pharyngeal motor evoked potential (PMEP) and Thenar motor evoked potential (TMEP), involving an electromyography (EMG) pharyngeal catheter inserted into the pharynx and gel electrodes to detect muscle activity.
- Be randomly allocated to one of the three preconditioning-conditioning procedures during each visit : 1Hz rTMS followed by 5Hz PES, sham 1Hz rTMS followed by 5Hz PES, and 1Hz rTMS followed by sham 5Hz PES
- Real rTMS will involve a figure-of-eight coil flat against the head delivering 1Hz stimulation at 90% of the thenar resting motor threshold.
- Sham rTMS will involve holding the coil perpendicular to the scalp to prevent brain stimulation.
- PES will involve a catheter delivering 0.2-ms pulses at 5Hz and 75% of the maximal tolerated intensity for 10 minutes. Sham PES will involve deactivating the current generator.
- Complete PMEP and TMEP measurements at baseline before intervention and every 15 minutes from 0 - 60 minutes after the rTMS-PES procedure.
- Complete a survey regarding tolerability and safety at the end of each visit.
详细描述
1 Study design This is a cross-over study with the order of experimental conditions randomized for each participant. The randomisation will be conducted using a randomisation program (Stats Direct, v2.7.8, StatsDirect Ltd, Altrincham, UK). Each condition will be given on separate days, at least one week apart.
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Participants Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research.
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Informed consent A participant information sheet will be given to each participant. A researcher with up-to-date Good Clinical Practice (GCP) training will be responsible for obtaining consent from the participants. He/she will explain the study purpose and nature and experimental procedures verbally to the participants. The participants will be given sufficient time (at least 24 hours) to read and digest the written information and discuss with the researcher about the study. The researcher will ensure the participants are volunteering to participate, understand the purpose and nature, experimental procedures, benefits and risks of the study before obtaining written consent from them. The participants should understand that they have the rights to withdraw from the study anytime throughout the study.
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Study Procedures
Participants will undergo either active or sham preconditioned 1 Hz rTMS interventions with 30 min intervals before active or sham 5 Hz PES (Fig 1). Each session involved:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Healthy volunteers over the age of 18 will be recruited through adverts placed around Salford Royal Hospital, on a University of Manchester website which advertises for research volunteers and through a departmental database of volunteers who have expressed an interest in future research. There is no upper age limit for potential participants.
排除标准
- •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)
研究组 & 干预措施
real rTMS + real PES
Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES.
干预措施: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) (Device)
real rTMS + sham PES
Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive sham 5Hz PES.
干预措施: sham pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) (Device)
real rTMS + real PES
Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES.
干预措施: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) (Device)
sham rTMS + real PES
Participants will receive sham 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES.
干预措施: pharyngeal electrical stimulation (Digitimer model DS7; Welwyn-Garden City, Herts, UK) (Device)
sham rTMS + real PES
Participants will receive sham 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive real 5Hz PES.
干预措施: sham repetitive transcranial magnetic stimulation(Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) (Device)
real rTMS + sham PES
Participants will receive real 1Hz rTMS over the dominant hemisphere, followed by a 30min interval. After that the participants will receive sham 5Hz PES.
干预措施: repetitive transcranial magnetic stimulation (Magstim Super Rapid stimulator, The Magstim Company Ltd, Whitland, UK) (Device)
结局指标
主要结局
Percentage change of the amplitude of PMEP after intervention
时间窗: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
The percentage change (in percents) of the amplitude (in millivolts) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
Percentage change of the latency of PMEP after intervention
时间窗: Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention
The percentage change (in percents) of the latency (in milliseconds) of bilateral PMEPs at different timepoints after the full intervention will be calculated as compared with the baseline measurement before the intervention.
次要结局
- Percentage change of the amplitude of TMEP after intervention(Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention)
- Percentage change of the latency of TMEP after intervention(Before intervention, 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the intervention)
研究者
Prof Shaheen Hamdy PhD FRCP
Professor
University of Manchester