Cognitive Function
Conditions
Keywords
Cognitive function, transcutaneous vagal nerve stimulation, autonomic nervous system, cognitive health/impairment
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.
Interventions
Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device 4hours a day at 25Hz, 250 μs pulse width placed on tragus.
DEVICESham stimulation
Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.
Sponsors
University of Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotion GoNoGo | 5 minutes | Test of emotion inhibition and emotion regulation |
| Rey´s Auditory Verbal Learning Test | 12 minutes | Test of short-term memory, learning and recall to assess delayed memory |
| Flanker test | 4 minutes | Test that measures attention and executive function specifically response inhibition |
| Set Shifting | 7 minutes | Test of executive function specifically cognitive flexibility |
| N-back and 2N-back | 10 minutes | Test of executive function specifically working memory |
| Random number generation | 5 minutes | Test of executive function specifically cognitive flexibility |
| Emotion Recognition Task | 5 minutes | Test of emotion recognition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Czechia
Outcome results
None listed