Cognitive Function AbnormalLESCAFNCT07063381
Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation
A study testing tVNS in people with Cognitive Function Abnormal and Atrial Fibrillation (AF), run by Bakulev Scientific Center of Cardiovascular Surgery at 2 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Cognitive Function Abnormal, Atrial Fibrillation (AF)
- What is being tested?
- tVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- 9 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites
Bakulev National Medical Research Center for Cardiovascular Surgery
Moscow, 121552
Neurodynamics and Cognitive Technologies Research Laboratory of the Neuroscience Research Institute
Nizhny Novgorod
About this study
Official title: Effect of Low-frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve on Cognitive Function in Patients With Atrial Fibrillation
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).
- Being tested
- tVNS
- 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
- Medical subject headings
- Cognition Disorders, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNSDevice
tVNS will be performed daily after workouts for 60 minutes over a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Changes in reaction time (RT) during the perception and classification of ambiguous visual stimuli (Necker cubes) by a patient. The test is conducted with simultaneous EEG recording during the visual task (determining the orientation of the Necker cube - right-oriented or left-oriented configuration).
The presentation of ambiguous stimuli, such as the Necker cube, leads to an increase in reaction time due to the need to resolve perceptual conflict and make decisions under uncertainty. Parallel EEG recording reveals specific neural correlates of this process (N200 - conflict, P300 - decision/classification, frontal theta - cognitive control, gamma - perceptual reorganization), which are directly related to the observed changes in reaction speed. Analysis of these EEG markers together with RT provides deep insight into brain dynamics during the processing of ambiguous information.
Measured: 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
Changes in the level of attention during the perception and classification of ambiguous visual stimuli (Necker cubes) by a patient. The test is conducted with simultaneous EEG recording during the visual task (determining the orientation of the Necker cube - right-oriented or left-oriented configuration). The frequency of actual errors (incorrect reporting) is assessed.
The presentation of ambiguous stimuli, such as the Necker cube, requires an increased level of attention (especially executive control), reflected in specific EEG patterns (theta, N2, P3). The primary sources of errors are perceptual instability (switches during response) and unresolved conflict/uncertainty. Analysis of EEG (ERN/Pe) allows studying the process of error detection and correction itself.
Measured: 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).
Changes in the MoCA-8 score. Scores on the MoCA-8 test range from 0 to 30, where a score <26 may indicate cognitive impairment.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start9 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function AbnormalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double-blind controlled trial in two groups (1:1)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
- Sponsor type
- Other government
- Collaborators
- Lobachevsky University
- Responsible party
- Principal investigator, Vladimir A Shvartz, MD, Bakulev Scientific Center of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063381
- Sponsor's protocol ID
- 0034.2025
- Other IDs
- H-465-99_2025-2027
- Acronym
- LESCAF
- Status last verified
- May 2026
- First submitted
- 23 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve on Cognitive Function in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07063381
- Acronym / sponsor ID
- LESCAF / 0034.2025
- Keywords
- transcutaneous vagus nerve stimulation, vagus nerve stimulation, atrial fibrillation, auricular vagus nerve stimulation, cognitive functions, memory, executive functions, information processing speed
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular SurgeryOther government
- Collaborators
- Lobachevsky University
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized double-blind controlled trial in two groups (1:1)
| Arm | Type | Receives |
|---|---|---|
| Active tVNS | Active comparator | Device: tVNSActive 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. |
| Sham tVNS | Sham comparator | Device: tVNSFictitious 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNStVNS will be performed daily after workouts for 60 minutes over a period of 6 months. | Device | Active tVNS, Sham tVNS |
Primary outcome
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.
Changes in the characteristics of time-frequency analysis of the neural activity of the brain associated with the performance of a cognitive task.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS in people with Cognitive Function Abnormal and Atrial Fibrillation (AF), run by Bakulev Scientific Center of Cardiovascular Surgery at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.