The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

Cognitive Function Clinical Trial

Official title:

The Effect of Transcutaneous Vagus Nerve Stimulation on Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070547
• Other study ID #: COG-STIM
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2019
• Source: University of Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Device:
• Transcutaneous vagal nerve 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
Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.

Locations

Country	Name	City	State
Czechia	University of Ostrava, Faculty of Medicine	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University of Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rey´s Auditory Verbal Learning Test	Test of short-term memory, learning and recall to assess delayed memory	12 minutes
Primary	Flanker test	Test that measures attention and executive function specifically response inhibition	4 minutes
Primary	Set Shifting	Test of executive function specifically cognitive flexibility	7 minutes
Primary	N-back and 2N-back	Test of executive function specifically working memory	10 minutes
Primary	Random number generation	Test of executive function specifically cognitive flexibility	5 minutes
Primary	Emotion Recognition Task	Test of emotion recognition	5 minutes
Primary	Emotion GoNoGo	Test of emotion inhibition and emotion regulation	5 minutes
Secondary	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).	63 minutes