Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Symptoms and Cardiovascular Autonomic Profile of Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change of Autonomic symptoms
研究概览
简要总结
Postural Orthostatic Tachycardia Syndrome (POTS) is characterized by symptoms of chronic orthostatic intolerance such as fatigue, lightheadedness, dizziness, palpitations and by pronounced tachycardia upon standing.
The aims of the present research study are to test whether a daily transcutaneous vagal nerve stimulation (tVNS) performed for 14 consecutive days may improve heart rate response and reduce disabling symptoms while standing.
详细描述
Postural Orthostatic Tachycardia Syndrome (POTS) is characterized by symptoms of chronic orthostatic intolerance such as fatigue, lightheadedness, dizziness, palpitations and by pronounced tachycardia without hypotension upon standing. In healthy volunteers, transcutaneous vagal nerve stimulation (tVNS) may result in increased cardiac vagal activity and reduced vascular sympathetic drive with minimal, if any, side effects. It is possible to hypothesize that any therapeutic intervention aimed at increasing cardiac vagal modulation might result in clinical improvement of the disease.
The aim of the study are to evaluate the medium-term effects of tVNS, performed every day for a 14 days on cardiovascular autonomic profile and symptoms intensity in POTS patients.
Study and General Design
Phase 1- Enrollment:
23 POTS patients, older than 18 years of age, will be consecutively enrolled. Each POTS patient will undergo complete medical evaluation at the time of enrollment, which will take place seven days before baseline recordings (i.e. Control day, see below), in order to individually optimize the tVNS amplitude and get patients familiarized with both the tVNS procedure and the clinical laboratory environment. On the same day, 30-minute continuous tVNS will be delivered to the patients under rigorous medical and hemodynamic supervision to exclude any kind of short term adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of Postural Orthostatic Tachycardia Syndrome
- •Older than 18 years
排除标准
- •Dysautonomias other than POTS
- •Neurodegenerative diseases
- •History/family history of seizures
- •Atrial fibrillation and other relevant cardiac rhythm disturbances
- •Chronic inflammatory diseases
- •Chronic use on anti-inflammatory drugs
- •Other neurological or psychiatric diseases
- •Pacemakers or other electronic implants inserted into the body
- •Coronary disorders
- •Elevated intracranial blood pressure
- •Assumption of drugs facilitating seizures
- •Assumption ofpsychiatric drugs
- •Alcohol abuse
结局指标
主要结局
Change of Autonomic symptoms
时间窗: Change from baseline Autonomic symptoms at 14 days
Autonomic symptoms will be assessed by the Composite Autonomic Symptom Scale (COMPASS 31) questionnaire. This is based on 31 items and a score ranging from 0 to100, 0 being the absence of symptom and 100 the greatest symptom intensity. The COMPASS 31 will be used to quantify the following autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, urinary and pupillomotor dysfunction symptoms.
次要结局
- Change in Heart rate(Change from baseline cardiovascular autonomic profile at 14 days)
- Change in respiration rate(Change from baseline cardiovascular autonomic profile at 14 days)
- Change in blood pressure(Change from baseline cardiovascular autonomic profile at 14 days)