Effect of Low-frequency Electrical Stimulation of the Auricular Branch of the Vagus Nerve on Cognitive Function in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Dynamics of neural activity of the brain.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active tVNS
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.
干预措施: tVNS (Device)
Sham tVNS
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.
干预措施: tVNS (Device)
结局指标
主要结局
Dynamics of neural activity of the brain.
时间窗: 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.
次要结局
- 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.)
研究者
Vladimir A Shvartz, MD
Principal Investigator
Bakulev Scientific Center of Cardiovascular Surgery