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Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation

Study acronym: LESCAF
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Sep 1, 2025 to Sep 9, 2025
    • Site contacts updated at 1 of 2 sites
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07063381
Lead Sponsor Bakulev Scientific Center of Cardiovascular Surgery
Collaborators: Lobachevsky University
Conditions
(from sponsor)
Cognitive Function Abnormal, Atrial Fibrillation (AF)
Related terms Atrial Fibrillation, Cognition Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov