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 of 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. A comprehensive team has been assembled to perform the study, including experts in gastrointestinal motility, traditional Chinese medicine and clinical patient care.
Public Health Relevance Statement: Gastroparesis is a disease featured with slow emptying of the stomach and symptoms of nausea and vomiting. No good treatment options are available. In this project a noninvasive and home-based therapy for the disease is proposed and will be tested in patients. It uses small stimulators attached to special points in the arms and legs and electrically (and weakly) stimulates these points via skin electrodes, the same as used in the EKG test.
Project Terms: Abdomen; Abdominal; Acupoints; Acupuncture Points; Acupuncture procedure; Acute; Affect; Analgesic Cutaneous Electrostimulation; Arm; Bilateral; CCK; Caliber; Cell Locomotion; Cell Migration; Cell Movement; Cellular Migration; China; Chinese Traditional Medicine; Cholecystokinin; Chronic; Chung I Hsueh; Clinical; Clinical Medicine; Clinical Research; Clinical Study; Colitis, Mucous; Colon, Irritable; Constipation; Crossover Design; Designs, Cross-Over; Development; Diabetes Mellitus; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Ketosis-Resistant; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Slow-Onset; Diabetes Mellitus, Stable; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type II; Diameter; Diarrhea; Disease; Disorder; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Dyspepsia; ECG; EKG; Electric Stimulation, Transcutaneous; Electrical Stimulation, Transcutaneous; Electroacupuncture; Electrocardiogram; Electrocardiography; Electrodes; Feasibility Studies; Functional Gastrointestinal Disorders; Gastric Emptying; Gastric Emptyings; Gastric Stasis; Gastrointestinal Hormones; Gastrointestinal Motility; Gastroparesis; General Population; General Public; Goals; His-Ser-Asp-Ala-Val-Phe-Thr-Asp-Asn-Tyr-Thr-Arg-Leu-Arg-Lys-Gln-Met-Ala-Val-Lys-Lys-Tyr-Leu-Asn-Ser-Ile-Leu-Asn; Home; Home environment; Indigestion; Indigestions; Irritable Bowel Syndrome; Leg; MODY; Mainland China; Manuals; Maturity-Onset Diabetes Mellitus; Measures; Medical; Medical Sciences, Clinical; Medicine, Chinese Traditional; Methods; Motility; Motility, Cellular; NIDDM; Nausea and Vomiting; Needles; Neuropeptide Tyrosine; Non-Insulin Dependent Diabetes; Non-Insulin-Dependent Diabetes Mellitus; Output; PC6; PC6 extract; PHM27; Pain; Painful; Pancreozymin; Pathogenesis; Patient Care; Patient Care Delivery; Patients; Percutaneous Electric Nerve Stimulation; Percutaneous Electrical Nerve Stimulation; Physicians; Procedures; Refractory Disease; Reporting; Role; Satiation; Satiations; Shapes; Skin; Solid; Stomach; Symptoms; T2D; T2DM; TENS; Testing; Therapeutic; Transcutaneous Electric Nerve Stimulation; Transcutaneous Electrical Nerve Stimulation; Transcutaneous Nerve Stimulation; Transdermal Electrostimulation; Treatment Efficacy; Type 2 diabetes; Type II diabetes; Upper arm; Uropancreozymin; VIP; Vasoactive Intestinal Peptide; Vasoactive Intestinal Polypeptide; Vasointestinal Peptide; Visit; Wireless Technology; Zhong Yi Xue; acupuncture; adult onset diabetes; base; cell motility; design; design and construction; designing; diabetes; diabetic; diabetic gastroparesis; disease/disorder; dysmotility; dysmotility syndrome; experiment; experimental research; experimental study; gastric; ghrelin; improved; ketosis resistant diabetes; maturity onset diabetes; motilin; motility disorder; neuropeptide Y; new approaches; novel approaches; novel strategies; novel strategy; pine cone extract 6; research study; satiety; social role; spastic colon; stomach emptying; therapeutic efficacy; therapeutically effective; wireless
