The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

NCT04070547 | Completed

• 1 other identifier: COG-STIM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Function

Keywords

Cognitive function; transcutaneous vagal nerve stimulation; autonomic nervous system; cognitive health/impairment

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Supine and task dependent heart rate variability

  63 minutes

Study Arms (4)

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).

Device: Transcutaneous vagal nerve stimulation

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).

Device: Sham stimulation

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).

Device: Transcutaneous vagal nerve stimulation

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).

Device: Sham stimulation

Interventions

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.

Early tVNS; Late tVNS

Sham stimulation DEVICE

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

Early Sham; Late Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• relatively healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ostrava: lead

Study Sites (1)

University of Ostrava, Faculty of Medicine

Ostrava, Czechia

Location

Study Officials

• Vera Jandackova

  University of Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: January 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 6, 2021

Record last verified: 2019-09

Locations

CZ (1)