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临床试验/NCT02409069
NCT02409069已完成不适用

Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年11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
44
试验地点
2
主要终点
Analysis of amplitude of P300 component of ERPs

研究概览

简要总结

The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers.

Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.

The release of noradrenaline in the brain will be measured non-invasively by the P300 component of event-related potentials in the electro-encephalogram (EEG) via an auditory oddball paradigm.

Research to elucidate the working mechanism of non-invasive neurostimulation can help to identify subpopulations who will respond well to a treatment and can provide insights that could contribute to the optimalisation of the stimulation parameters, with as possible consequence a better clinical outcome.

Some studies indicate that stimulation of the vagus nerve can optimally influence memory, possibly via the noradrenergic system. This study will investigate if the effects of invasive vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve stimulation.

The influence of transcutaneous vagus nerve stimulation on memory will be measured via a neuropsychological memory task that investigates the ability to focus attention. The correlation between the performance on the memory task and the signal analysis of the auditory oddball task could give an indication about the underlying working mechanism of transcutaneous vagus nerve stimulation on memory.

This will be the first step to investigate whether transcutaneous vagus nerve stimulation can be used as innovative intervention for cognitive decline.

详细描述

First a sympathetic skin response (SSR) will be measured to investigate whether the SSR could be used as a method to measure the activity of the locus coeruleus non-invasively.

There are 3 conditions:

  1. transcutaneous vagus nerve stimulation
  2. sham stimulation
  3. no stimulation

The conditions will be randomized.

In each condition the participant will do the oddball task and then the memory task. Between the conditions there is a wash-out period of 30 minutes. After completion of all 3 conditions and after a wash-out period of 30 minutes, the participant will do a final recognition task (part of the memory task in total).

研究设计

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

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers between 18 and 30 years
  • Bachelor, Master or PhD students

排除标准

  • Neurological or psychiatric disease

研究组 & 干预措施

Sham stimulation (Nemos®, Cerbomed GmbH)

Sham Comparator

Stimulation of the earlobe

干预措施: Sham stimulation (Nemos®, Cerbomed GmbH) (Device)

No stimulation

No Intervention

No stimulation

Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)

Experimental

Stimulation of the ramus auricularis of the vagus nerve (ear)

干预措施: Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH) (Device)

结局指标

主要结局

Analysis of amplitude of P300 component of ERPs

时间窗: 15 minutes

Performance on memory task as measured by number of correctly remembered words

时间窗: 15 minutes

次要结局

  • Analysis of latency of P300 component of ERPs(15 minutes)
  • Performance on memory task as measured by number of correctly recognized words(15 minutes)

研究者

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

Neurologie

Prof. dr. Kristl Vonck

University Hospital, Ghent

研究点 (2)

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