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临床试验/NCT04040803
NCT04040803已完成不适用

Characterizing the Application of Transcranial Alternating Current Stimulation and Transcranial Random Noise Stimulation Over Human Pharyngeal Motor Cortex

University of Manchester1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年5月3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
17
试验地点
1
主要终点
Changes of pharyngeal motor evoked potential amplitudes (PMEPs)

研究概览

简要总结

Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory.

Swallowing problems are life-threatening symptom among patients with brain impairments and elderly people. Until now, there are no studies investigating whether tACS and tRNS can have a beneficial effect on swallowing function in human. Our aim is to examine the effects of different strengths of tACS and tRNS to determine the best approach for brain stimulation that controls swallowing action, before using these techniques in patients with (neurological) swallowing disorders.

Participants: Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
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
是

入选标准

  • •Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history

排除标准

  • •a history of epilepsy
  • •cardiac pacemaker
  • •previous brain surgery
  • •previous swallowing problems
  • •risk of potential pregnancy
  • •metal in the head or eyes
  • •use of medication that acts on the central nervous system.

研究组 & 干预措施

10 Hz tACS

Experimental

Stimulation will be applied at 10 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min.

10 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

干预措施: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) (Device)

20 Hz tACS

Experimental

Stimulation will be applied at 20 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min.

20 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

干预措施: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) (Device)

70Hz tACS

Experimental

Stimulation will be applied at 70 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min.

70 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

干预措施: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) (Device)

0.1-640Hz tRNS

Experimental

Stimulation will be applied at 0.1-640Hz tRNS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min.

0.1-640Hz tRNS will be performed over the pharyngeal cortex region and contralateral supraorbital region.

干预措施: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) (Device)

Sham

Sham Comparator

Stimulation will be performed only for 10 s before the fade out, with 20 Hz tACS and an intensity of 1.5 mA (peak to peak).

Sham condition will be applied over pseudo-stimulation of pharyngeal cortex region and contralateral supraorbital region.

干预措施: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) (Device)

结局指标

主要结局

Changes of pharyngeal motor evoked potential amplitudes (PMEPs)

时间窗: These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.

Cortical excitability of the pharyngeal motor cortices are being assessed as the primary endpoints. Therefore, the changes in EMG pharyngeal motor evoked potential amplitudes (PMEPs) following the intervention applied to pharyngeal motor cortex are being collected.

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

Principal Investigator

University of Manchester

研究点 (1)

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