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临床试验/NCT04070547
NCT04070547已完成不适用

The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

University of Ostrava1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月1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
80
试验地点
1
主要终点
Emotion Recognition Task

研究概览

简要总结

Cognitive health is generally considered a key component of quality of life. Current evidence indicates that a large number of individuals are at a high risk for cognitive impairment from many causes as they age. In order to preserve and enhance positive out-comes by targeted efficient preventive and therapeutic strategies it is important to understand potential mechanisms and predictors of cognitive health and impairment. Withdrawal of vagal (parasympathetic) activity has been proposed as one of the biological pathways involved in cognitive impairment. Transcutaneous vagus nerve stimulation (tVNS) has shown potential as a noninvasive and safe therapeutic treatment due to its direct influence on brain systems involved in cognition. However, the role of vagal modulation in cognitive functioning and impairment and the influence of tVNS, particularly long-term tVNS, on cognition are not yet completely understood. Here the investigators aim to investigate the effect of long-term (14days) intensive transcutaneous vagus nerve stimulation on cognitive functions in relatively healthy young-to-older adults.

详细描述

Cognitive health is generally considered a key component of quality of life. Current evidence indicates that a large number of individuals are at high risk for cognitive impairment from many causes as they age. In order to preserve and enhance positive cognitive health outcomes by targeted efficient preventive and therapeutic strategies, it is important to understand potential mechanisms and predictors of cognitive health and impairment. Withdrawal of vagal (parasympathetic) activity has been proposed as one of the biological pathways involved in cognitive impairment. Transcutaneous vagus nerve stimulation (tVNS) has shown potential as noninvasive and safe therapeutic treatment due to its direct influence on brain systems involved in cognition. However, the role of vagal modulation in cognitive functioning and impairment and the influence of tVNS, particularly long-term tVNS, on cognition are not yet completely understood. Here the investigators aim to investigate the effect of long-term (14days) intensive transcutaneous vagus nerve stimulation on cognitive functions in relatively healthy young-to-older adults.

Little work has been done investigating the effect of long-term tVNS in healthy men and women. In light of preventive medicine, the question is whether increased vagus nerve modulation and long-term tVNS improve memory and executive functioning and potentially help to prevent healthy person vulnerable to cognitive impairment from manifesting cognitive deficits. Or if they can slow down the process of cognitive aging inevitable for every human being.

研究设计

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

盲法说明

The sham stimulation experience is very similar to the tVNS stimulation experience. Participants will be provided a detailed instructions and manual how to use the tVNS device and at what part of the ear they will place the electrode on.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •relatively healthy adults

排除标准

  • •cardiovascular disease (e.g. arythmia, history of coronary heart disease, history of stroke),
  • •severe mental condition (e.g. significant depression, schizophrenia, autism, significant anxiety disorder)
  • •severe neurological condition (e.g. epilepsy, brain tumors, significant migraine, traumatic brain injury)
  • •brain surgery
  • •pregnancy

研究组 & 干预措施

Early tVNS

Experimental

First 2 weeks this group will receive transcutaneous vagal nerve stimulation 4 hours a day (day 1 to day 14). Then participants will be followed for another 2 weeks (day 15 to day 28) without any intervention. Laboratory testing will be carried out three times with average of 14 days between sessions: on day 1 (pre-intervention), on day 14 (post-intervention) and on day 28 (follow-up).

干预措施: Transcutaneous vagal nerve stimulation (Device)

Early Sham

Experimental

First 2 weeks this group will receive sham stimulation 4hours a day (day 1 to day 14). Then participants will be followed for another 2 weeks (day 15 to day 28). Laboratory testing will be carried out three times with average of 14 days between sessions: on day 1 (pre-intervention), on day 14 (post-intervention) and on day 28 (follow-up).

干预措施: Sham stimulation (Device)

Late tVNS

Experimental

First 2 weeks this group will be on a waiting list (day 1 to day 14). Then participants will receive transcutaneous vagal nerve stimulation 4hours a day (day 15 to day 28). Laboratory testing will be carried out three times with average of 14 days between sessions: on day 1 (waiting), on day 14 (pre-intervention) and on day 28 (post-intervention).

干预措施: Transcutaneous vagal nerve stimulation (Device)

Late Sham

Experimental

First 2 weeks this group will be on a waiting list (day 1 to day 14). Then participants will receive sham stimulation 4hours a day (day 15 to day 28). Laboratory testing will be carried out three times with average of 14 days between sessions: on day 1 (waiting), on day 14 (pre-intervention) and on day 28 (post-intervention).

干预措施: Sham stimulation (Device)

结局指标

主要结局

Emotion Recognition Task

时间窗: 5 minutes

Test of emotion recognition

N-back and 2N-back

时间窗: 10 minutes

Test of executive function specifically working memory

Random number generation

时间窗: 5 minutes

Test of executive function specifically cognitive flexibility

Set Shifting

时间窗: 7 minutes

Test of executive function specifically cognitive flexibility

Emotion GoNoGo

时间窗: 5 minutes

Test of emotion inhibition and emotion regulation

Flanker test

时间窗: 4 minutes

Test that measures attention and executive function specifically response inhibition

Rey´s Auditory Verbal Learning Test

时间窗: 12 minutes

Test of short-term memory, learning and recall to assess delayed memory

次要结局

  • Supine and task dependent heart rate variability(63 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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