TEA for Gastroparesis

Overseen By Omar Daassa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Parenteral feeding, Gastric surgery, Pregnancy, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that your current medications remain stable, meaning you should not change your medication regimen for at least 2 weeks before starting the study. However, if you have diabetes, you can adjust your insulin doses daily.

What data supports the effectiveness of the treatment TEA for Gastroparesis?

Research shows that transcutaneous electrical acustimulation (TEA) can improve nausea and stomach activity in people with diabetic gastroparesis. Additionally, similar treatments like gastric electrical stimulation have been found to help with symptoms of gastroparesis. ^{1 2 3 4 5}

Is Transcutaneous Electrical Acustimulation (TEA) safe for humans?

Transcutaneous Electrical Acustimulation (TEA) has been studied for various conditions like gastroparesis and functional dyspepsia, and no significant safety concerns have been reported in these studies. ^{1 2 6 7 8}

How is the TEA treatment for gastroparesis different from other treatments?

Transcutaneous Electrical Acustimulation (TEA) is unique because it is a needleless, non-invasive treatment that uses electrical stimulation to improve symptoms like nausea by enhancing vagal activity (nerve activity that controls the stomach) and myoelectrical activity (muscle electrical activity) in the stomach, unlike traditional medications or surgical options. ^{1 2 3 6 8}

What is the purpose of this trial?

This trial is testing a device that sends weak electrical currents to the leg and arm to help people with gastroparesis. The goal is to see if it can improve stomach movement and reduce digestive symptoms.

Research Team

Borko Nojkov, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

My medications have been the same for the last 2 weeks, except for insulin adjustments.

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

You have experienced slow digestion in the past 3 years.

Exclusion Criteria

Pregnancy or expect to conceive during the course of the study

My diabetes is not under control (HbA1c > 11%).

I have symptoms like delayed stomach emptying but I am not diabetic.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a 3-in-1 gastric functional test including EGG, ECG, and water satiety drink test for gastric accommodation. Participants are randomized and trained on device usage.

1 day

1 visit (in-person)

Treatment

Participants receive either active treatment or sham stimulation for 8 weeks. Weekly calls are made to check for adverse events and compliance.

8 weeks

Weekly calls (virtual)

Crossover Treatment

Participants who received sham stimulation are unblinded and may opt to receive 4 weeks of active treatment.

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• Transcutaneous Electrical Acustimulation (TEA)

Trial Overview 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.

Participant Groups

Group I: Treatment group Experimental Treatment 1 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 group Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Transcutaneous electrical stimulation using vacuum interferential current (IFC) significantly improved symptoms of functional dyspepsia, such as epigastric discomfort and bloating, in a study involving 44 patients over 12 treatment sessions across 4 weeks.

The therapy was found to be superior to placebo not only during treatment but also one month after, indicating its potential as a non-invasive option for patients who do not respond to traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial: interferential electric stimulation in functional dyspepsia patients - a prospective randomized study. Köklü, S., Köklü, G., Ozgüçlü, E., et al.[2010]

In a study involving 18 subjects with idiopathic gastroparesis, synchronized transcutaneous electroacupuncture (STEA) did not significantly reduce nausea compared to sham treatment, but it did improve gastric dysrhythmia as indicated by a 24% increase in normal electrogastrogram (EGG) waves after treatment.

STEA also resulted in a three-fold increase in vagal activity compared to sham, suggesting it may enhance vagal function, which is important for digestive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of needleless transcutaneous electroacupuncture in synchronization with breathing for symptomatic idiopathic gastroparesis: A blinded and controlled acute treatment trial. Song, G., Sun, Y., Bashashati, M., et al.[2019]

Gastric electrical stimulation was found to be a safe and effective alternative to gastrectomy for patients with refractory gastroparesis, showing no 30-day mortality and a median hospital stay of just 3 days.

The procedure significantly improved patients' symptoms, allowed 19 previously dependent patients to discontinue nutritional support, and led to a notable increase in body mass index and gastric emptying rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis. Mason, RJ., Lipham, J., Eckerling, G., et al.[2022]

Electroacupuncture at the lower he-sea point (Zusanli, ST 36) significantly improved symptoms of gastroparesis more effectively than electroacupuncture at both Zusanli and Zhongwan points, with a total effective rate of 93.3% compared to 70.0%.

Both treatment groups showed improvements in gastroparesis symptoms, but the group receiving treatment solely at Zusanli had better outcomes in terms of gastric emptying time and residual rates, suggesting that the combination of acupoints may have antagonistic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative study on effect of electroacupuncture at lower he-sea point of stomach and he-sea matching front-mu points for gastroparesis]. Zhou, Y., Ma, HQ., Yang, ZJ., et al.[2020]

Gastric electrical stimulation (GES) significantly increased gastric volume at the lesser curvature of the stomach using modified Enterra conditions and implantable gastric stimulation (IGS), indicating its potential to improve gastric tone in certain settings.

The effects of GES on gastric tone are site-specific and depend on the stimulation conditions, which may help tailor GES therapy for patients with gastroparesis and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect on gastric tone of gastric electrical stimulation with trains of short pulses varies with sites and stimulation conditions. Lei, Y., Xing, J., Chen, J.[2021]

Transcutaneous electrical acustimulation (TEA) significantly improved dyspeptic symptoms and gastric accommodation in 30 patients with postprandial distress syndrome compared to a sham treatment, indicating its potential efficacy as a noninvasive therapy.

TEA treatment was associated with increased vagal activity and reduced levels of IL-6 in the duodenal mucosa, suggesting that its therapeutic effects may involve modulation of neuroimmune mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture Enhances Gastric Accommodation via the Autonomic and Cytokine Mechanisms in Functional Dyspepsia. Chen, X., Chen, X., Chen, B., et al.[2023]

Transcutaneous electrical acustimulation (TEA) significantly reduced nausea and bloating in patients with liver cancer after transcatheter arterial chemoembolization (TACE), particularly in the delayed phase after treatment, with no effects observed in the acute phase.

TEA improved gastrointestinal function by increasing normal gastric slow waves and vagal activity, which correlated with reduced anorexia, indicating a potential mechanism for its effectiveness in alleviating TACE-induced GI disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Improves Gastrointestinal Disturbances Induced by Transcatheter Arterial Chemoembolization in Patients With Liver Cancers. Zhu, Y., Li, X., Ma, J., et al.[2022]

Needleless transcutaneous electrical acupuncture (TEA) significantly reduces nausea in patients with diabetic gastroparesis (DMGP), as shown by a decrease in nausea scores from 5.9 to 2.5 after treatment.

TEA not only alleviates nausea but also improves gastric function, indicated by an increase in normal gastric slow wave activity from 60% to 70%, and alters brain activity patterns associated with nausea, suggesting both central and peripheral mechanisms are involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central and Peripheral Effects of Transcutaneous Acupuncture Treatment for Nausea in Patients with Diabetic Gastroparesis. Sarosiek, I., Song, G., Sun, Y., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical trial: interferential electric stimulation in functional dyspepsia patients - a prospective randomized study. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of needleless transcutaneous electroacupuncture in synchronization with breathing for symptomatic idiopathic gastroparesis: A blinded and controlled acute treatment trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Comparative study on effect of electroacupuncture at lower he-sea point of stomach and he-sea matching front-mu points for gastroparesis]. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The effect on gastric tone of gastric electrical stimulation with trains of short pulses varies with sites and stimulation conditions. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Electroacupuncture Enhances Gastric Accommodation via the Autonomic and Cytokine Mechanisms in Functional Dyspepsia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Improves Gastrointestinal Disturbances Induced by Transcatheter Arterial Chemoembolization in Patients With Liver Cancers. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Central and Peripheral Effects of Transcutaneous Acupuncture Treatment for Nausea in Patients with Diabetic Gastroparesis. [2022]