Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation
NCT ID: NCT07063381
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-01
2027-12-31
Brief Summary
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The auricular (auricular) branch of the vagus nerve is a peripheral branch of the vagus nerve innervating the skin of the auricle in the area of the tragus and the inner part of the external auditory canal. The tVNS engages the sensory fibres of the vagus nerve and thus mimics the sensory input to the brainstem, forming the so-called auriculo-vagal afferent pathway. Since these fibres project directly to the nucleus of the solitary pathway (solitary tract), which, in turn, has direct and indirect projections to the nuclei providing noradrenergic, endorphinergic and serotoninergic fibres in various parts of the brain regulating systemic indices of cardiovascular, respiratory and immunological functions, the organism's response to stimulation of the auricular branch of the vagus nerve is systemic in nature.
Stimulation of this nerve can modulate central nervous system (CNS) activity, affecting processes related to memory, attention and emotional state. Mechanisms of action of tVNS include modulation of parasympathetic activity, enhancement of neuroplasticity through increased expression of neurotrophic factors (e.g., BDNF), improvement of cerebral blood circulation, and regulation of neuroinflammation (reduction of proinflammatory cytokines).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active tVNS
Active stimulation will be carried out using the tVNS device with an ear clip attached to the tragus of the left ear at a frequency of 20 Hz, 250 μs at a current slightly below the discomfort threshold. The device's operating mode is active therapeutic.
tVNS
tVNS will be performed daily after workouts for 60 minutes over a period of 6 months.
Sham tVNS
Fictitious stimulation will be carried out using the tVNS device with an ear clip attached to the tragus of the left ear at a frequency of 20 Hz, 250 μs at a current slightly below the discomfort threshold. The device's operating mode is research mode.
tVNS
tVNS will be performed daily after workouts for 60 minutes over a period of 6 months.
Interventions
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tVNS
tVNS will be performed daily after workouts for 60 minutes over a period of 6 months.
Eligibility Criteria
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Inclusion Criteria
* Permanent form of AF,
* Severe and mild cognitive impairment (\<26 points on the MoCA-8 test),
* The possibility of regular repeat visits for 6 months.
Exclusion Criteria
* Expressed sinus bradycardia with resting heart rate \< 40 bpm
* Any oncological diseases,
* Severe chronic liver and kidney pathology,
* Chronic viral infections.
60 Years
90 Years
ALL
No
Sponsors
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Lobachevsky University
UNKNOWN
Bakulev Scientific Center of Cardiovascular Surgery
OTHER_GOV
Responsible Party
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Vladimir A Shvartz, MD
Principal Investigator
Locations
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Bakulev National Medical Research Center for Cardiovascular Surgery
Moscow, , Russia
Neurodynamics and Cognitive Technologies Research Laboratory of the Neuroscience Research Institute
Nizhny Novgorod, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-465-99_2025-2027
Identifier Type: OTHER
Identifier Source: secondary_id
0034.2025
Identifier Type: -
Identifier Source: org_study_id
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