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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Device: Transcutaneous vagal nerve stimulation; Device: Sham stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Ostrava, Czechia
    • University of Ostrava, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Device: 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.
EXPERIMENTAL: 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).	Device: Sham stimulation; Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.
EXPERIMENTAL: 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).	Device: 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.
EXPERIMENTAL: 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).	Device: Sham stimulation; Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rey´s Auditory Verbal Learning Test	Test of short-term memory, learning and recall to assess delayed memory	12 minutes
Flanker test	Test that measures attention and executive function specifically response inhibition	4 minutes
Set Shifting	Test of executive function specifically cognitive flexibility	7 minutes
N-back and 2N-back	Test of executive function specifically working memory	10 minutes
Random number generation	Test of executive function specifically cognitive flexibility	5 minutes
Emotion Recognition Task	Test of emotion recognition	5 minutes
Emotion GoNoGo	Test of emotion inhibition and emotion regulation	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supine and task dependent heart rate variability	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).	63 minutes

Collaborators and Investigators

• Sponsor: University of Ostrava
• Investigators: Principal Investigator: Vera Jandackova, University of Ostrava

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: autonomic nervous system; Cognitive function; transcutaneous vagal nerve stimulation; cognitive health/impairment
• Other Study ID Numbers: COG-STIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No