Inducing Metaplasticity in Human Pharyngeal Motor Cortex Through Preconditioned Repetitive Transcranial Magnetic Stimulation (rTMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharyngeal motor evoked potentials (PMEPs)
研究概览
简要总结
The purpose of the study is to determine the effects of giving 2 doses of brain stimulation through repetitive transcranial magnetic stimulation (rTMS) on swallowing neurophysiology (brain function) in healthy adults.
详细描述
Recent studies have suggested that repetitive transcranial magnetic stimulation (rTMS), which is a well-established and tried and tested non-invasive (no surgical procedures involved) brain stimulation technique that can vary brain activities, may be used as a treatment for patients with swallowing difficulties. However, results have also showed that the response to the treatment is different among individuals. A possible explanation for this variation is related to the brain's level of activity preceding rTMS. The hypothesis of this study is that this variation may be minimized by regulating the brain state with an additional dose of rTMS prior to the intended rTMS session (preconditioned rTMS). This may subsequently improve the outcomes of rTMS.
Therefore, this study aims to better regulate the response of the brain to rTMS. The findings of this study will provide the basis for future development of optimal rTMS treatment protocols for patients with swallowing difficulties.
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
- 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 aged 18 years old or above; and
- •No medical complications or significant past medical history
排除标准
- •History of epilepsy;
- •Previous history of neurosurgery;
- •Previous swallowing problem;
- •Implanted brain electrodes, cardiac pacemaker; or
- •Use of medications (predominantly taking multiple anti-depressants) that lower neural threshold
研究组 & 干预措施
Sham 1Hz rTMS--5Hz rTMS
Participants will receive sham 1Hz rTMS, then immediately followed by 5Hz rTMS.
干预措施: rTMS (Device)
1Hz rTMS--5Hz rTMS
Participants will receive 1Hz rTMS, then immediately followed by 5Hz rTMS.
干预措施: rTMS (Device)
1Hz rTMS--30-minute break--5Hz rTMS
Participants will receive 1Hz rTMS, then followed by 30 minutes break, then followed by 5Hz rTMS.
干预措施: rTMS (Device)
5Hz rTMS--45-minute break--1Hz rTMS
Participants will receive 5Hz rTMS, then followed by 45 minutes break, then followed by 1Hz rTMS.
干预措施: rTMS (Device)
5Hz rTMS--90-minute break--1Hz rTMS
Participants will receive 5Hz rTMS, then followed by 90 minutes break, then followed by 1Hz rTMS.
干预措施: rTMS (Device)
Sham 5Hz rTMS--1Hz rTMS
Participants will receive sham 5Hz rTMS, then immediately followed by 1Hz rTMS.
干预措施: rTMS (Device)
1Hz rTMS--60-minute break--5Hz rTMS
Participants will receive 1Hz rTMS, then followed by 60 minutes break, then followed by 5Hz rTMS.
干预措施: rTMS (Device)
5Hz rTMS--1Hz rTMS
Participants will receive 5Hz rTMS, then immediately followed by 1Hz rTMS.
干预措施: rTMS (Device)
结局指标
主要结局
Pharyngeal motor evoked potentials (PMEPs)
时间窗: Change from baseline up to 150 minutes after rTMS
Motor evoked potentials from the pharynx will be elicited by single pulse transcranial magnetic stimulation and recorded.
Thenar (hand) motor evoked potentials (TMEPs)
时间窗: Change from baseline up to 150 minutes after rTMS
Motor evoked potentials from the hand will be elicited by single pulse transcranial magnetic stimulation and recorded.
次要结局
未报告次要终点
研究者
Prof Shaheen Hamdy PhD FRCP
Professor of Neurogastroenterology
University of Manchester