← Back to Search

TEA for Gastroparesis

N/A

Recruiting

Led By Borko Nojkov, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 and visit 2 at 8 weeks

Awards & highlights

Study Summary

This trial will test whether a device that sends electrical current to specific points on the body can improve symptoms of gastroparesis.

Who is the study for?

This trial is for people with gastroparesis, a condition where the stomach empties slowly. Participants must have had delayed gastric emptying in the last 3 years and stable medications for at least 2 weeks. They should experience ongoing severe or moderate symptoms like vomiting or bloating. Those with recent stomach surgery, uncontrolled diabetes, pregnancy plans during the study, or implanted medical devices cannot join.Check my eligibility

What is being tested?

The trial tests a device called Transcutaneous Electrical Accustimulator (TEA) that delivers weak electrical currents to potentially improve digestive symptoms and gastric motility in gastroparesis patients. It involves two points of stimulation: one on the leg and another on the arm.See study design

What are the potential side effects?

Possible side effects from TEA may include skin irritation at the site of electrode placement, discomfort from electrical stimulation, muscle twitching, lightheadedness during treatment sessions but are generally considered minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had severe symptoms like vomiting or nausea for at least 3 months due to diabetic gastroparesis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 and visit 2 at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 and visit 2 at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 and visit 2 at 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)

Secondary outcome measures

Electrocardiogram (ECG)

Electrogastrogram (EGG)

Gastric accommodation

+1 more

Other outcome measures

36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment groupExperimental Treatment1 Intervention

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.

Group II: Sham groupPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,377,998 Total Patients Enrolled

1 Trials studying Gastroparesis

3 Patients Enrolled for Gastroparesis

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,301 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,874 Total Patients Enrolled

1 Trials studying Gastroparesis

26 Patients Enrolled for Gastroparesis

Media Library

Transcutaneous Electrical Acustimulation (TEA) Clinical Trial Eligibility Overview. Trial Name: NCT05362578 — N/A

Gastroparesis Research Study Groups: Treatment group, Sham group

Gastroparesis Clinical Trial 2023: Transcutaneous Electrical Acustimulation (TEA) Highlights & Side Effects. Trial Name: NCT05362578 — N/A

Transcutaneous Electrical Acustimulation (TEA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362578 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are eligible to join the trial?

"Indeed, details visible on clinicaltrials.gov indicate that this medical trial is currently recruiting volunteers. It was first published on September 8th 2022 and the information was recently updated in October 11th 2022. The study seeks to recruit 60 participants from a single clinical site."

Answered by AI

Who is eligible for participation in this medical experiment?

"This clinical trial is looking for 60 individuals suffering from gastroparesis that fall between the age brackets of 18 and 80. There are specific requirements entrants must meet, such as having a history of diabetic symptoms lasting over three months, at least one severe symptom or two moderate ones (e.g., vomiting, nausea), documented delayed stomach emptying within 3 years, and no changes in their medication routine for 2 weeks prior to the experiment."

Answered by AI

Does this clinical trial have any age restrictions, with regard to those 75 or less?

"This clinical trial is seeking volunteers aged 18 to 80. Additionally, 4 studies are available for those younger than 18 and 27 trials for participants over 65 years of age."

Answered by AI

Are individuals eligible to enroll in this experiment right now?

"Affirmative. The medical trial is presently enrolling participants, as evidenced by the information on clinicaltrials.gov. This research project was initially posted on September 8th 2022 and underwent its last update October 11th 2022. 60 individuals are required to be recruited from a singular location for this study's completion."

Answered by AI