Effect Of Percutaneous Electrical Nerve Field Stimulation (PENFS) On Symptom Control And Autonomic Nervous System Activity In Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Gastroparesis Cardinal Symptom Index Daily Dairy
研究概览
简要总结
The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.
详细描述
Each participant will be randomized to receive Percutaneous Electrical Nerve Field Stimulation (PENFS) treatment with or without stimulation. The study involves 6 study visits. Study procedures include: removing and replacing the PENFS device, questionnaires, ECG, assessment use of galvanic skin response (GSR), pneumatic belt to assess breathing, physical examine, and blood draws.
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)
盲法说明
The Sham arm will have single blind masking. The participant will not know if they are in the Stimulation arm or the Sham arm; only the coordinator/tech will know the status of the arm.
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
- •Wiling to have one teaspoon (5 ml) of blood drawn.
- •Diagnosed with gastroparesis for twelve months or longer
- •Diagnosed with diabetes either Type 1 or Type 2
- •Documented delayed gastric emptying (>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years.
- •Upper GI endoscopy indicating no mechanical obstruction performed in the last five years.
- •Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting.
- •Documented Hb A1c within three months of screening or at the time of screening (<=8.0)
排除标准
- •Unable to provide consent
- •Pregnant females
- •Medical records indicate intestinal pseudo-obstruction
- •Diagnosed with cardiac arrhythmia
- •History of prior gastric surgery
- •History of vagotomy
- •History of organ transplantation
- •History of seizures
- •Diagnosed with primary swallowing disorders
- •Subjects who are dependent on drugs like Marinol for their condition
- •Those diagnosed with psychogenic vomiting and not related to gastroparesis
- •Medically unstable subjects
- •Those at high surgical risk
- •Subjects taking narcotic analgesics daily.
- •Those with poorly controlled diabetes mellitus (Hgb A1c>8) within three months of screening or at the time of screening.
- •Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded
- •Those having a cardiac pacemaker will be excluded from the study.
研究组 & 干预措施
ACTIVE (electrical charge)
The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses throughout the auricle.
干预措施: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION (Device)
Sham percutaneous electrical nerve field stimulation (no electrical charge)
The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance will not transmit any electrical impulses.
干预措施: Sham percutaneous electrical nerve field stimulation (Device)
结局指标
主要结局
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
时间窗: Five weeks
ANMS GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY this tool uses a list of 7 criteria for rating gastric symptoms. The scale ratings are: None, Mild, Moderate, Severe, and Very Severe.
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms
时间窗: Five weeks
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.
次要结局
- Change in Heart Rate Variability(Five weeks.)
- Change in Anxiety(Five weeks)
- Change in the measure of depression(Five weeks)
研究者
Thomas V. Nowak
Professor of Clinical Medicine
Indiana University