Transcutaneous Electroacupuncture for Gastroparesis

NCT ID: NCT01469286

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-07-31

Brief Summary

Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of patients with functional dyspepsia that affects about 10%-25% of the general population. Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of gastroparesis include nausea, vomiting, early satiety and abdominal bloating.

Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current stimulation instead of manual manipulations of the needles. Recent studies in our lab with EA or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well as dyspeptic symptoms. In this project, a micro-stimulator is designed and developed for the TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin next to the stimulation electrodes and therefore the patient can resume normal daily activity while being treated by TEA. This is not only attractive but also more effective since TEA can be performed more often and for longer durations.

This exploratory project is designed to study the feasibility, efficacy and certain mechanisms of the proposed method of "wireless" TEA in patients with gastroparesis. Firstly the feasibility of the chronic use the proposed micro-stimulator will be studied. Secondly, the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis will be investigated in a double-blinded crossover design in patients with diabetic or idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of gastroparesis with TEA will be investigated.

Conditions

Diabetic Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEA

Needleless electroacupuncture at ST36 and PC6

Group Type: ACTIVE_COMPARATOR

TEA

Intervention Type: DEVICE

Electroacupuncture at ST36

Sham-TEA

Needleless acupuncture at sham-points

Group Type: PLACEBO_COMPARATOR

Sham-TEA

Intervention Type: DEVICE

Electroacupuncture at sham-points

Interventions

TEA

Electroacupuncture at ST36

Intervention Type: DEVICE

Sham-TEA

Electroacupuncture at sham-points

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms);
• Abnormal gastric emptying defined as more than 10% of gastric retention at 4 hrs after a standard solid meal (see below) during the past 3 months;
• Males and females between ages 18-65 yrs;
• Subjects with high probability for compliance and completion of the study.
• Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.
• Diabetes.

Exclusion Criteria

1) History of gastric bezoar or diverticulitis. 2) Severe daily abdominal pain requiring medications for relief. 3) Severe weight loss, greater than 10 lbs over the preceding 2 months. 4) Uncontrolled diabetes with a hemoglobin A1C greater than 10. 5) Excessively delayed gastric emptying time: more than 90% of a standard meal retained after 2 hours. 6) Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery. 7) Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy; 8) Surgery within the past 3 months. 9) Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test). 10) Those who have been treated with acupuncture or those who are familiar with acupuncture points. 11). Allergic to Ensure, strawberry jam and eggs.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: collaborator

Transtimulation Research, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiande Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Transtimulation Research, Inc

Locations

University of Mississippi

Jackson, Mississippi, United States

Texas tech university health science center

El Paso, Texas, United States

Countries

United States

Other Identifiers

R43AT004489

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TEA-Gastroparesis

Identifier Type: -

Identifier Source: org_study_id