The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Device: Sham stimulation; Device: Transcutaneous vagal nerve stimulation

• Registration Number: NCT04070547
• Lead Sponsor: University of Ostrava

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.

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Status Verified: 2019-09
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Sham	Sham stimulation	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).
Late tVNS	Transcutaneous vagal nerve stimulation	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).
Early tVNS	Transcutaneous vagal nerve stimulation	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).
Late Sham	Sham stimulation	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Supine and task dependent heart rate variability	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).

Trial Locations

Locations (1)

University of Ostrava, Faculty of Medicine; 🇨🇿 Ostrava, Czechia