An interventional study of Transcutaneous vagal nerve stimulation and Sham stimulation in Cognitive Function, sponsored by University of Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by University of Ostrava · Not applicable, Interventional, and Basic science
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.
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.
University of Ostrava is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
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
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
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
Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device 4hours a day at 25Hz, 250 μs pulse width placed on tragus.
Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.
Rey´s Auditory Verbal Learning Test
Test of short-term memory, learning and recall to assess delayed memory
Time frame: 12 minutes
Flanker test
Test that measures attention and executive function specifically response inhibition
Time frame: 4 minutes
Set Shifting
Test of executive function specifically cognitive flexibility
Time frame: 7 minutes
N-back and 2N-back
Test of executive function specifically working memory
Time frame: 10 minutes
Random number generation
Test of executive function specifically cognitive flexibility
Time frame: 5 minutes
Emotion Recognition Task
Test of emotion recognition
Time frame: 5 minutes
Emotion GoNoGo
Test of emotion inhibition and emotion regulation
Time frame: 5 minutes
Supine and task dependent heart rate variability
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).
Time frame: 63 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Ostrava