Transcutaneous Electroacupuncture for Gastroparesis (TEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Transtimulation Research, Inc.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Mississippi Medical Center
Texas Tech University Health Sciences Center
Information provided by (Responsible Party):
Transtimulation Research, Inc
ClinicalTrials.gov Identifier:
NCT01469286
First received: November 8, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Gastric emptying of a solid meal.


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: July 2012
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469286

Contacts
Contact: Jiande Chen, PhD 409-747-3071 jianchen@utmb.edu
Contact: Jane Yin, MD 409-747-3080 jiyin@utmb.edu

Locations
United States, Mississippi
University of Mississippi Recruiting
Jackson, Mississippi, United States, 39214
Contact: Thomas Abell, MD    601-984-4540    tabell@medicine.umsmed.edu   
Principal Investigator: Thomas Abell, MD         
United States, Texas
Texas tech university health science center Recruiting
El Paso, Texas, United States, 79905
Contact: Irene Sarosiek, MD    915-545-6627    irene.sarosiek@ttuhsc.edu   
Principal Investigator: Richard McCallum, MD         
Sponsors and Collaborators
Transtimulation Research, Inc
University of Mississippi Medical Center
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Jiande Chen, PhD Transtimulation Research, Inc
  More Information

No publications provided

Responsible Party: Transtimulation Research, Inc
ClinicalTrials.gov Identifier: NCT01469286     History of Changes
Other Study ID Numbers: TEA-Gastroparesis, R43AT004489
Study First Received: November 8, 2011
Last Updated: November 8, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014