The Effect of Transauricular Vagal Nerve Stimulation (taVNS) on Cardiac Autonomic Functions in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Low frequency/ High frequency (LF/HF)
研究概览
简要总结
The aim of this study is to investigate the effect of transauricular vagal nerve stimulation (taVNS) on cardiac autonomic functions in patients with spinal cord injury (SCI).
详细描述
Spinal cord injury impairs autonomic pathways and ultimately cardiovascular homeostasis. Spinal cord injury affects the autonomic system, resulting in impaired cardiac autonomic functions. This study is designed to evaluate the effect of transauricular vagal nerve stimulation (taVNS) on cardiac autonomic functions in patients with spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-60
- •Having a traumatic spinal cord injury
- •Cervical spinal cord injury patients with a history of autonomic dysreflexia
- •At least 6 months after the injury
- •Signing an informed consent form showing consent to participate in the study
排除标准
- •Having a cardiac or neural pacemaker
- •Presence of pregnancy
- •Clinical coronary artery disease confirmed by invasive or coronary computed tomographic angiography
- •History of acute coronary syndrome (unstable angina, myocardial infarction)
- •Documented arrhythmia and/or use of antiarrhythmic drugs on ECG
- •Diagnosis of hypertension and use of antihypertensive drugs
- •Damaged skin lesion in the application area
研究组 & 干预措施
Cervical spinal cord injury - Active taVNS
The study included 30 traumatic spinal cord injury (SCI) patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active transaurikular vagal nerve stimülation (taVNS) group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).
干预措施: Active Transauricular Vagus Nerve Stimulation (Device)
Cervical spinal cord injury - Sham taVNS
The study included 30 traumatic SCI patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active taVNS group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).
干预措施: Sham Transauricular Vagus Nerve Stimulation (Device)
Lumbar spinal cord injury (Cauda Equina Syndrome)- Active taVNS
The study included 30 traumatic spinal cord injury (SCI) patients who fulfilled the criteria. Patients were divided into groups as group I cervical complete SCI patients in active taVNS group (n:10), group II cervical complete SCI patients in sham taVNS group (n:10) and group III lumbar SCI patients (diagnosed with cauda equina syndrome) in active taVNS group (n:10).
干预措施: Active Transauricular Vagus Nerve Stimulation (Device)
结局指标
主要结局
Low frequency/ High frequency (LF/HF)
时间窗: At baseline (Day 0), Day 1, Day 10, and Day 11
Heart rate variability (HRV) is considered an indicator of neural control over the heart and is measured by analyzing the variations in NN intervals between consecutive R waves on an electrocardiogram (ECG).Frequency-domain analyses determine the power of fluctuations in heart rate signals within specific frequency bands. This analysis can be conducted using short-term Holter ECG recordings or data from 5-minute segments of a 24-hour Holter ECG. In our study, the short-term effects of taVNS on frequency domain HRV parameters will be evaluated using data obtained from 24-hour Holter ECG recordings on the pre-stimulation day (day 0) and day 11, and the acute effects will be assessed using data from 15-minute Holter recordings on day 1 and day 10.The LF/HF ratio is also one of the frequency-domain HRV parameters. LF/HF (ratio): low-to-high frequency power ratio The LF/HF ratio serves as an indicator of sympathovagal balance.
次要结局
- Total Power(At baseline (Day 0) and Day 11)
- Heart rate response to the Valsalva maneuver (Valsalva ratio)(At baseline (Day 0) and Day 11)
- Respiratory heart rate variability(At baseline (Day 0) and Day 11)
- Ultra Low Frequency (ULF)(At baseline (Day 0) and Day 11)
- Very Low Frequency (VLF)(At baseline (Day 0) and Day 11)
- Low Frequency (LF)(At baseline (Day 0), Day 1, Day 10, and Day 11)
- High Frequency (HF)(At baseline (Day 0), Day 1, Day 10, and Day 11)
- SDNN: Standard Deviation of NN intervals(At baseline (Day 0) and Day 11)
- SDNNi: Mean of the standard deviations of all NN intervals for all 5-minute segments(At baseline (Day 0) and Day 11)
- SDANN: Standard deviation of the averages of NN intervals in all 5-minute segments(At baseline (Day 0) and Day 11)
- RMSSD: Root Mean Square of the Successive Differences(At baseline (Day 0) and Day 11)
- pNN50: Percentage of successive NN intervals that differ by more than 50 ms(At baseline (Day 0) and Day 11)
- Heart rate response to the tilt test(At baseline (Day 0) and Day 11)
- Blood pressure response to the tilt test(At baseline (Day 0) and Day 11)
研究者
Ayşenur ŞİMŞEK YAĞLIOĞLU
medical doctor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital