Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis
Primary Purpose
Gastroparesis With Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcutaneous electrical accustimulation at treatment point.
transcutaneous electrical accustimulation at sham point.
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis With Diabetes Mellitus
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
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment group
Sham group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
Full Information
NCT ID
NCT05362578
First Posted
March 31, 2022
Last Updated
August 29, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT05362578
Brief Title
Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis
Official Title
Wearable Transcutaneous Electrical Acustimulation for Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis With Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Half of subjects will be randomized to the sham arm, and half will be randomized to the treatment arm.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical accustimulation at treatment point.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical accustimulation at sham point.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
Description
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
Secondary Outcome Measure Information:
Title
Gastric emptying
Description
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.
Time Frame
8 weeks
Title
36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)
Description
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
Title
Gastric accommodation
Description
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.
Time Frame
8 weeks
Title
Electrogastrogram (EGG)
Description
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
Title
Electrocardiogram (ECG)
Description
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
Other Pre-specified Outcome Measures:
Title
36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)
Description
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
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colin Burnett
Phone
734-647-2806
Email
bucolin@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borko Nojkov, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Burnett
Phone
734-647-2806
Email
bucolin@med.umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared
Citations:
PubMed Identifier
25989154
Citation
Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738. Erratum In: Pain Med. 2015 Nov;16(11):2217.
Results Reference
background
PubMed Identifier
24657460
Citation
Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20.
Results Reference
background
PubMed Identifier
28915981
Citation
Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30.
Results Reference
background
PubMed Identifier
31347247
Citation
Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26.
Results Reference
background
PubMed Identifier
29925916
Citation
Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21.
Results Reference
background
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Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis
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