Wearable Transcutaneous Electrical Acustimulation for Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
研究概览
简要总结
The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to test if the device will impact the gastrointestinal (GI) symptoms and gastric motility in study participants with gastroparesis.
详细描述
This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis. This will be done over a 12 week period during which each participant will undergo two visits. There will be two total visits that each follow the same schedule. During the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and water satiety drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive an additional 4 weeks of treatment with the device.
Note: The gastric emptying breathalyzer test (GEBT) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.
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 (Participant)
盲法说明
Half of subjects will be randomized to the sham arm, and half will be randomized to the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening.
- •Documented delayed gastric emptying within past 3 years
- •Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes)
排除标准
- •Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube
- •History of gastric surgery such as fundoplication, gastrectomy, or vagotomy
- •Symptoms suggestive of gastroparesis with no diagnosis of diabetes
- •Pregnancy or expect to conceive during the course of the study
- •Uncontrolled diabetes mellitus (HbA1c > 11%).
- •Having any implanted medical device, such as cardiac pacemaker or Entera device
研究组 & 干预措施
Sham group
Subjects will be trained to use the devices at sham points and will undergo sham stimulation for the first 8 weeks. At visit two, after unmasking, subjects will optionally be trained on the treatment points and may participate in treatment for 4 weeks.
干预措施: transcutaneous electrical accustimulation at sham point. (Device)
Treatment group
Subjects will be trained to use the devices at the treatment points and will undergo the treatment twice per day for 8 weeks. Following the first 8 weeks, at visit two, the devices will be collected by the study team.
干预措施: transcutaneous electrical accustimulation at treatment point. (Device)
结局指标
主要结局
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
时间窗: From baseline to up to 84 days
A 24-hours recall period and five symptoms related to delayed emptying from the stomach: nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting. Scoring of ANMS GCSI-DD: The severity scores of four gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain) range from 0-none to 4-very severe. Vomiting frequency is scored as 0 episodes, 1 episode, 2 episodes, 3 episodes or 4 or more episodes (capped as 4). The ANMS GCSI-DD total gastroparesis symptom daily score is generated by summing the scores on each of the five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. Thus, the minimum score is 0 and the maximum score is 4. Higher numbers indicate greater symptom impact. Scores will be compared from day 0 to day 84.
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
时间窗: Up to 84 days
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) symptom daily score was generated by summing the scores on each of five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes), each ranging from 0 (none) to 4 (very severe) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. The minimum score was 0 and the maximum score was 4. Higher numbers indicated greater symptom impact. Scores will be compared from day 0 to day 84.
次要结局
- 36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)(8 weeks)
- Gastric accommodation(8 weeks)
- Electrocardiogram (ECG)(Visit 1 and visit 2 at 8 weeks)
- Electrogastrogram (EGG)(Visit 1 and visit 2 at 8 weeks)
- 36-Item Short Form Survey Instrument (SF-36) to Measure Quality of Life (QOL)(8 weeks)
- Gastric Accommodation(8 weeks)
- Electrocardiogram (ECG) - High-frequency Power (HFn)(8 weeks)
- Electrocardiogram (ECG) - Sympathetic Index (SI)(8 weeks)
- Electrocardiogram (ECG) - LFn/HFn Ratio(8 weeks)
研究者
Borko Nojkov
Clinical Lecturer - Specialty Gastroenterology, Internal Medicine
University of Michigan