Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Cognitive Function Abnormal, Atrial Fibrillation (AF)

In brief

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).

Key facts

Study ID

NCT07063381

Run by

Bakulev Scientific Center of Cardiovascular Surgery

People needed

60

Starts

2025-09-09

Expected to finish

2027-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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