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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Transcutaneous Electrical Acustimulator (TEA) to determine its effectiveness for gastroparesis, a condition where the stomach empties its contents too slowly, causing symptoms like nausea and bloating. The device delivers a mild electrical current to specific body points to enhance digestion. Participants will use either the real device or a sham version to compare results. Ideal candidates have experienced diabetic gastroparesis symptoms for at least three months and have severe or multiple moderate symptoms. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for gastroparesis.

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 prior data suggests that the Transcutaneous Electrical Acustimulator (TEA) is safe for treating gastroparesis?

Research has shown that Transcutaneous Electrical Acustimulation (TEA) is generally safe. Studies have found it to be well-tolerated without causing serious side effects, making TEA a promising option for treating digestive issues like gastroparesis. While minor side effects might occur, they are typically not serious. Participants in past studies reported feeling comfortable with the treatment. Overall, the safety information reassures those considering joining a clinical trial involving TEA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Electrical Acustimulation (TEA) is unique because it offers a non-invasive approach to managing gastroparesis symptoms, unlike traditional treatments that often involve medication or surgery. Researchers are excited about TEA because it uses gentle electrical pulses to stimulate acupuncture points, potentially improving digestive motility without the side effects associated with drugs like prokinetics or antiemetics. Additionally, TEA allows for patient-administered treatment, offering a convenient and flexible option compared to more invasive procedures.

What evidence suggests that the Transcutaneous Electrical Acustimulator (TEA) is effective for gastroparesis?

Research has shown that Transcutaneous Electrical Acustimulation (TEA), which participants in this trial may receive, can greatly improve symptoms of gastroparesis. In earlier studies, TEA effectively reduced the five main symptoms of this condition. It also helped the stomach move food through the digestive system more efficiently, improving gastric motility. These findings suggest that TEA could be a promising treatment for people with gastroparesis symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Borko Nojkov, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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 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]

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]

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 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]

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]

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]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.70184

Transcutaneous Electrical Acustimulation Improves ... 3.3 Effects of TEA on Gastroparesis Symptoms. The TEA treatment was effective in significantly improving each of the five major gastroparesis ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05362578

Study Details | NCT05362578 | Transcutaneous Electrical ... This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5383119/

PMC - PubMed Central The mean percentage of normal gastric slow waves was decreased to 60.0 ± 5.7% with VS (P < 0.05, vs 66.6 ± 4.5% at baseline), then improved to 69.2 ± 4.8% with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S109471592100177X

Transcutaneous Electrical Acustimulation Improves ... 1) In the acute phase (<24 h), TEA showed no effects on any of GI symptoms, compared with sham-TEA. 2) In the delayed phase (>24 h), TEA, ...

5. trialx.com trialx.com/clinical-trials/listings/259660/transcutaneous-electrical-acustimulation-tea-for-gastroparesis/

Transcutaneous Electrical Acustimulation (TEA) for ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01469286

Transcutaneous Electroacupuncture for Gastroparesis (TEA) This exploratory project is designed to study the feasibility, efficacy and certain mechanisms of the proposed method of "wireless" TEA in patients with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8895584/

Efficacy and safety of long-term transcutaneous ... The primary outcomes will be the residual rates of radioactivity in the stomach by gastric scintigraphy and total response rates. The secondary ...