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Enrolling by invitation NCT07063381

Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation

No phase Interventional Cognitive Function Abnormal Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tVNS.
Who it may be relevant to
Registry conditions: Cognitive Function Abnormal, Atrial Fibrillation (AF). Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Low-frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve on Cognitive Function in Patients With Atrial Fibrillation

Overview

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).

Interventions

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

Primary outcome measures

  • Dynamics of neural activity of the brain. [Time frame: 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 outcome measures (3)
  • Reaction Time (RT) Changes & EEG Correlates [Time frame: 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 [Time frame: 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). [Time frame: 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Russia · 2 centers
  • Bakulev National Medical Research Center for Cardiovascular Surgery — Moscow
  • Neurodynamics and Cognitive Technologies Research Laboratory of the Neuroscience Research — Nizhny Novgorod

Identifiers

NCT: NCT07063381 · 0034.2025 · H-465-99_2025-2027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗