The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

University of Ostrava

Status: Completed

Conditions: Cognitive Function

Treatments: Device: Sham stimulation; Device: Transcutaneous vagal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04070547

COG-STIM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Early tVNS

Experimental group

Description:

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).

Treatment:

Device: Transcutaneous vagal nerve stimulation

Early Sham

Experimental group

Description:

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).

Treatment:

Device: Sham stimulation

Late tVNS

Experimental group

Description:

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).

Treatment:

Device: Transcutaneous vagal nerve stimulation

Late Sham

Experimental group

Description:

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).

Treatment:

Device: Sham stimulation