Transcutaneous Electroacupuncture for Gastroparesis

NCT01469286 | Completed Phase 1 DMC

• 2 other identifiers: TEA-GastroparesisR43AT004489
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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

Keywords

delayed gastric emptying; nausea; vomiting; abdominal discomfort

Outcome Measures

Primary Outcomes (1)

• gastroparesis symptoms

  Gastroparetic symptom questionnaire will use the previously validated gastroparesis cardinal symptom index (GCSI), including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe).

  4 weeks

Secondary Outcomes (1)

• Gastric emptying

  4 weeks

Study Arms (2)

TEA

ACTIVE COMPARATOR

Needleless electroacupuncture at ST36 and PC6

Device: TEA

Sham-TEA

PLACEBO COMPARATOR

Needleless acupuncture at sham-points

Device: Sham-TEA

Interventions

TEA DEVICE

Electroacupuncture at ST36

TEA

Sham-TEA DEVICE

Electroacupuncture at sham-points

Sham-TEA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Transtimulation Research, Inc: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Mississippi Medical Center: collaborator
• Texas Tech University Health Sciences Center: collaborator

Study Sites (2)

University of Mississippi

Jackson, Mississippi, 39214, United States

Location

Texas tech university health science center

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Jiande Chen, PhD

  Transtimulation Research, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

US (2)