Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation

NCT07063381 | Not Yet Recruiting

• 2 other identifiers: 0034.2025H-465-99_2025-2027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Cognitive function in patients with atrial fibrillation (AF) is often impaired due to the complex influence of various factors (cerebral hypoperfusion, neurodegeneration, microemboli, hypertension, chronic inflammation). This leads to impairment of cognitive functions, including attention, memory, executive functions, and speed of information processing. The search for affordable and safe methods to maintain or improve cognitive function in this group of people is an urgent task of modern medicine. One of the promising approaches is percutaneous low-frequency electrical stimulation of the auricular branch of the vagus nerve (transcutaneous Vagus Nerve Stimulation - tVNS). 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).

Conditions

Cognitive Function Abnormal; Atrial Fibrillation (AF)

Keywords

transcutaneous vagus nerve stimulation; vagus nerve stimulation; atrial fibrillation; auricular vagus nerve stimulation; cognitive functions; memory; executive functions; information processing speed; modulation of parasympathetic activity; neuroplasticity; neurotrophic factors; cerebral blood flow; inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• Dynamics of neural activity of the brain.

  Changes in the characteristics of time-frequency analysis of the neural activity of the brain associated with the performance of a cognitive task.

  This parameter will be assessed at the beginning of the study (initially) and at the end of the study (6 months) in the active and fictitious stimulation groups.

Secondary Outcomes (3)

• Reaction Time (RT) Changes & EEG Correlates

  This parameter will be assessed at the beginning of the study (initially) and at the end of the study (6 months) in the active and fictitious stimulation groups.

• Attention Level Changes & Error Rates

  This parameter will be assessed at the beginning of the study (initially) and at the end of the study (6 months) in the active and fictitious stimulation groups.

• Dynamics of the cognitive test MoCA-8 (Montreal Cognitive Assessment).

  This parameter will be assessed at the beginning of the study (initially) and at the end of the study (6 months) in the active and fictitious stimulation groups.

Study Arms (2)

Active tVNS

ACTIVE COMPARATOR

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.

Device: tVNS

Sham tVNS

SHAM COMPARATOR

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.

Device: tVNS

Interventions

tVNS DEVICE

tVNS will be performed daily after workouts for 60 minutes over a period of 6 months.

Active tVNS; Sham tVNS

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 60 years,
• 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.

You may not qualify if:

• Atrioventricular blockade of 2-3 degree,
• Expressed sinus bradycardia with resting heart rate \< 40 bpm
• Any oncological diseases,
• Severe chronic liver and kidney pathology,
• Chronic viral infections.

Sponsors & Collaborators

• Bakulev Scientific Center of Cardiovascular Surgery: lead
• Lobachevsky University: collaborator

Study Sites (2)

Bakulev National Medical Research Center for Cardiovascular Surgery

Moscow, 121552, Russia

Location

Neurodynamics and Cognitive Technologies Research Laboratory of the Neuroscience Research Institute

Nizhny Novgorod, Russia

Location

MeSH Terms

Conditions

Cognition Disorders; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vladimir Shvartz

CONTACT

+79032619292; vashvarts@bakulev.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized double-blind controlled trial in two groups (1:1)

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)