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Transcutaneous Electroacupuncture for Gastroparesis (TEA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01469286
First Posted: November 10, 2011
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
University of Mississippi Medical Center
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Transtimulation Research, Inc
  Purpose

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.


Condition Intervention Phase
Diabetic Gastroparesis Device: TEA Device: Sham-TEA Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcutaneous Electroacupuncture for Gastroparesis

Resource links provided by NLM:


Further study details as provided by Transtimulation Research, Inc:

Primary Outcome Measures:
  • gastroparesis symptoms [ Time Frame: 4 weeks ]
    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).


Secondary Outcome Measures:
  • Gastric emptying [ Time Frame: 4 weeks ]
    Gastric emptying of a solid meal.


Enrollment: 26
Study Start Date: March 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TEA
Needleless electroacupuncture at ST36 and PC6
Device: TEA
Electroacupuncture at ST36
Placebo Comparator: Sham-TEA
Needleless acupuncture at sham-points
Device: Sham-TEA
Electroacupuncture at sham-points

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469286


Locations
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39214
United States, Texas
Texas tech university health science center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Transtimulation Research, Inc
National Center for Complementary and Integrative Health (NCCIH)
University of Mississippi Medical Center
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Jiande Chen, PhD Transtimulation Research, Inc
  More Information

Responsible Party: Transtimulation Research, Inc
ClinicalTrials.gov Identifier: NCT01469286     History of Changes
Other Study ID Numbers: TEA-Gastroparesis
R43AT004489 ( U.S. NIH Grant/Contract )
First Submitted: November 8, 2011
First Posted: November 10, 2011
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Transtimulation Research, Inc:
delayed gastric emptying
nausea
vomiting
abdominal discomfort

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms


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