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Completed

NCT Number: NCT04070547

The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

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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Key information

Conditions

Cognitive Function

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ostrava, Faculty of Medicine

Ostrava, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous vagal nerve stimulation

Device

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

Sham stimulation

Device

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

Primary outcomes

  1. Rey´s Auditory Verbal Learning Test

    Time frame: 12 minutes

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

  2. Flanker test

    Time frame: 4 minutes

    Test that measures attention and executive function specifically response inhibition

  3. Set Shifting

    Time frame: 7 minutes

    Test of executive function specifically cognitive flexibility

  4. N-back and 2N-back

    Time frame: 10 minutes

    Test of executive function specifically working memory

  5. Random number generation

    Time frame: 5 minutes

    Test of executive function specifically cognitive flexibility

  6. Emotion Recognition Task

    Time frame: 5 minutes

    Test of emotion recognition

  7. Emotion GoNoGo

    Time frame: 5 minutes

    Test of emotion inhibition and emotion regulation

Secondary outcomes

  1. Supine and task dependent heart rate variability

    Time frame: 63 minutes

    These tests will measure supine resting heart rate variability and changes in heart rate variability during each cognitive challenge task (memory, executive function and emotion regulation tests).

Sponsors and collaborators

Lead sponsor

University of Ostrava

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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