Clinical trial NCT05362578: Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis
Official title: Wearable Transcutaneous Electrical Acustimulation for Gastroparesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroparesis With Diabetes Mellitus
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
timeFrame: From baseline to up to 84 days
Secondary outcomes:
measure: 36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)
timeFrame: 8 weeks
measure: Gastric accommodation
timeFrame: 8 weeks
measure: Electrogastrogram (EGG)
timeFrame: Visit 1 and visit 2 at 8 weeks
measure: Electrocardiogram (ECG)
timeFrame: Visit 1 and visit 2 at 8 weeks
Other outcomes:
measure: 36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)
timeFrame: 12 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Borko Nojkov, MD
role: PRINCIPAL_INVESTIGATOR
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