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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
41
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.
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.
University of Michigan
Ann Arbor, Michigan, United States
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.
Time frame: From baseline to up to 84 days
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.
Time frame: 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.
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Time frame: 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
Time frame: 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
Time frame: Visit 1 and visit 2 at 8 weeks