A Pilot Study of a Randomized Sham-control Auricular TENS Unit Stimulation to Improve Symptoms Through Vagal Modulation in Pediatric Functional Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Heart Rate Variability at 8 Weeks
研究概览
简要总结
The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.
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
- Double (Participant, Care Provider)
盲法说明
Participants will be sent home at baseline with a TENS unit and a sealed envelope with instructions for device settings. The envelope will contain instructions for either sham stimulation or active stimulation (unknown to the performing coordinator and participant). Both groups will receive a new device and another set of instructions from the study team at 4 weeks. It is possible and permitted that the performing study coordinator will become aware of which group the subject is in when checking in on the subject.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome
- •English Speaking
排除标准
- •Patients who are unable to stand upright during the heart rate variability recording
- •Patients with a known bleeding disorder
- •Gastric or cardiac pacer or defibrillator
- •Poor circulation in lower limbs
- •Swollen or inflamed outer ear
- •Abdominal or inguinal hernia
- •Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
- •Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response
- •Inability to answer questionnaires or report pain on a 0-10 visual analog scale.
结局指标
主要结局
Change in Heart Rate Variability at 8 Weeks
时间窗: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)
时间窗: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks
时间窗: Assessed at baseline, week 4, and week 8. Change in baseline to week 8.
Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation
Change in Heart Rate Variability at 4 Weeks
时间窗: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)
时间窗: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.
Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks
时间窗: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation.
次要结局
- Change From Baseline in Functional Disability Inventory (Child and Adolescent)(Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.)
- Change From Baseline in Symptom Intensity Questionnaire(Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported.)
- Change From Baseline in Pain Catastrophizing Scale (Child)(Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported.)
- Change From Baseline in Revised Child Anxiety and Depression Scale(Assessed at baseline, week 4, and week 8. Changes in generalized anxiety & depression t-scores (translated from raw subscale scores) in baseline to week 4 and baseline to week 8 are reported.)
- Change From Baseline in Functional Disability Inventory (Parent)(Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.)
- Change From Baseline in Pain Catastrophizing Scale (Parent)(Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported.)
研究者
Gisela Grotewold Chelimsky
Professor of Pediatrics
Virginia Commonwealth University