Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Each visit will take place over two days and both visits will follow the same schedule. During the first day, subjects will undergo a gastric emptying breath test which will be used to measure stomach emptying, which will last approximately 5 hours. During the second day, 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 nutrient drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the smartphone and 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 two-day 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 4 weeks of treatment with the device.

Official Title
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Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

Conditions
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Gastroparesis With Diabetes Mellitus

Intervention / Treatment
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* Device: transcutaneous electrical accustimulation at treatment point.
* Device: transcutaneous electrical accustimulation at sham point.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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. | Device: transcutaneous electrical accustimulation at treatment point.<br>* The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location previously seen to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.<br>|
| Sham Comparator: Sham group<br>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. | Device: transcutaneous electrical accustimulation at sham point.<br>* The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location which has not been shown to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) | 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. | From baseline to up to 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying | A noninvasive FDA-approved method for assessing gastric emptying. GEBT T1/2 is a continuous measurement representing the calculated time to empty from the stomach into the small intestine half of a 13C-labeled, 230kcal test meal (27g of rehydrated, pasteurized scrambled egg mix containing a dose of 43mg of 13C [provided by approximately 100mg of 13C-Spiruina], 6 saltine crackers, 180mL water, and consisting of 29.9% kcal as carbohydrates, 25.5% as protein, and 44.6% as fat). The breath samples will be collected at baseline, 45, 90, 120, 150, 180 and 240 minutes after the test meal, and then shipped to Cairn Diagnostics for analysis. A baseline sample will be collected at visit 1. | 8 weeks | 
| 36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL) | A 36 question assessment to score overall quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | 8 weeks | 
| Gastric accommodation | A liquid nutrient drink test will be performed during which the patient will be asked to drink at a speed of 60ml/min until reaching the maximum tolerable volume (MTV). The postprandial symptoms of dyspepsia will be assessed at 10 , 20 and 30 min after completing the drink test with the patient scoring symptoms of bloating, fullness, nausea and pain using a visual analogue scale (VAS) with 100 mm lines and the words unnoticeable (0 mm) and unbearable (100mm) at each end. The sum of the four 100 mm visual analogue scales for each symptom provides an aggregate symptom score, the higher the score the greater the disability. A baseline test will be performed at visit 1. | 8 weeks | 
| Electrogastrogram (EGG) | An EGG will be performed twice at both the baseline and at the 8 week visit. One 30-minute EGG will be performed prior to the gastric accommodation test and one 30-minute EGG will be performed after the nutrient drink test. The goal is to measure gastric slow waves. The difference in slow waves will be compared pre- and post- gastric accommodation. Slow waves will also be compared between visit 1 and visit 2 | Visit 1 and visit 2 at 8 weeks | 
| Electrocardiogram (ECG) | An ECG will be performed twice at both the baseline and at the 8 week visit. One 30-minute ECG will be performed prior to the gastric accommodation test and one 30-minute EGG will be performed after the nutrient drink test. The goal is to measure autonomic function via calculating the heart rate variability (HRV). The difference in HRV will be compared pre- and post- gastric accommodation. HRV will also be compared between visit 1 and visit 2 | Visit 1 and visit 2 at 8 weeks |