Transcutaneous Electroacupuncture for Gastroparesis (TEA)
Recruitment status was Recruiting
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.
|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|
- 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).
- Gastric emptying [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Gastric emptying of a solid meal.
|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)|
Active Comparator: TEA
Needleless electroacupuncture at ST36 and PC6
Electroacupuncture at ST36
Placebo Comparator: Sham-TEA
Needleless acupuncture at sham-points
Electroacupuncture at sham-points
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469286
|Contact: Jiande Chen, PhDemail@example.com|
|Contact: Jane Yin, MDfirstname.lastname@example.org|
|United States, Mississippi|
|University of Mississippi||Recruiting|
|Jackson, Mississippi, United States, 39214|
|Contact: Thomas Abell, MD 601-984-4540 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Richard McCallum, MD|
|Principal Investigator:||Jiande Chen, PhD||Transtimulation Research, Inc|