Pilot Study--The Effects of Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Change in Composite Autonomic Symptom Score (COMPASS-31)
研究概览
简要总结
The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.
详细描述
Project purpose: The investigators will study the use of non invasive vagal nerve stimulation in newly diagnosed adolescent patients with POTS to see if symptom management improves over 2 months. Surveys will include COMPASS-31. Child Functional Disability Inventory, and PHQ-9. Patient logs will evaluate headache frequency, exercise duration and VNS use.
Research objectives: The investigators hypothesize that:
Primary Aim 1. Use of noninvasive vagal nerve stimulation will decrease autonomic symptom intensity compared to control group.
Primary Aim 2. Use of noninvasive vagal nerve stimulator will improve child function.
Primary Aim 3. Heart rate elevation measured by head up tilt table test will decrease in the treatment group compared to the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient's age 12-19 years of age
- •Newly diagnosed POTS at Mayo Clinic in Rochester
- •Head up tilt table test results in a heart rate increase of 40 or more bpm
- •Consent is able to be obtained appropriately per age
排除标准
- •POTS patients with orthostatic hypotension
- •POTS patients with vasovagal syncope
- •Use of medications other than midodrine or metoprolol
- •Inability to independently utilize the GammaCore device
- •Inability to independently complete surveys or patient logs
- •Patients receiving hormonal therapy other than birth control
- •Prior neck surgery
- •Metallic implant present
- •Cardiac disorder
- •Presence of an eating disorder
- •Use of a feeding tube
研究组 & 干预措施
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS
The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilize a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.
干预措施: STEPS management protocol (Other)
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
干预措施: GammaCore intervention (Device)
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)
Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.
干预措施: STEPS management protocol (Other)
结局指标
主要结局
The Change in Composite Autonomic Symptom Score (COMPASS-31)
时间窗: Baseline; 8 Weeks
The change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
The Change in Child Functional Disability Inventory Scores
时间窗: Baseline; 8 Weeks
The change in Child Functional Disability Inventory scores from baseline to eight weeks. The Child Functional Disability Inventory assesses the physical and psychosocial functioning of children due to their physical health. It consists of 15 items that measure activity limitations due to being sick or not feeling well. The total scores range from 0 to 60 with higher scores indicating greater perceived functional disability.
The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests
时间窗: Baseline; 8 Weeks
The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.
次要结局
- Change in Exercise Duration (Minutes) in Adolescent Patients With POTS(Baseline; 8 Weeks)
- Change in the Number of Headaches Experienced by Adolescent Patients With POTS(Baseline; 8 Weeks)
- Change in PHQ-9 Scores in Adolescent Patients With POTS(Baseline; 8 Weeks)
研究者
Lytitia M. Shea
Principal Investigator
Mayo Clinic