The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of 4 groups - receiving either transcutaneous vagal nerve stimulation or sham in first 2 weeks (Early group), or being first 2 weeks on the waiting list and receiving either transcutaneous vagal nerve stimulation or sham in the second 2 weeks of the study participation (Late group). The randomization will have two steps: 1.) Prior to the first laboratory session all participants will be assigned into either Early or Late group; 2.) At the end of the pre-intervention laboratory session participants will be randomized between tVNS or sham stimulation.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Early tVNS

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).

Group Type EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device 4hours a day at 25Hz, 250 μs pulse width placed on tragus.

Early Sham

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).

Group Type EXPERIMENTAL

Sham stimulation

Intervention Type DEVICE

Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.

Late tVNS

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).

Group Type EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device 4hours a day at 25Hz, 250 μs pulse width placed on tragus.

Late Sham

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).

Group Type EXPERIMENTAL

Sham stimulation

Intervention Type DEVICE

Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.

Interventions

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Transcutaneous vagal nerve stimulation

Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device 4hours a day at 25Hz, 250 μs pulse width placed on tragus.

Intervention Type DEVICE

Sham stimulation

Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* relatively healthy adults

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes