Transcutaneous Electroacupuncture for Gastroparesis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | July 2012 |
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.
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.
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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