Clinical trial NCT04070547: The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function
Official title: The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: Cognitive function
transcutaneous vagal nerve stimulation
autonomic nervous system
cognitive health/impairment
Lead sponsor: University of Ostrava
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rey´s Auditory Verbal Learning Test
timeFrame: 12 minutes
measure: Flanker test
timeFrame: 4 minutes
measure: Set Shifting
timeFrame: 7 minutes
measure: N-back and 2N-back
timeFrame: 10 minutes
measure: Random number generation
timeFrame: 5 minutes
measure: Emotion Recognition Task
timeFrame: 5 minutes
measure: Emotion GoNoGo
timeFrame: 5 minutes
Secondary outcomes:
measure: Supine and task dependent heart rate variability
timeFrame: 63 minutes
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University of Ostrava, Faculty of Medicine
Study officials:
affiliation: University of Ostrava
name: Vera Jandackova
role: PRINCIPAL_INVESTIGATOR
References: