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TRANSCUTANEOUS ELECTROACUPUNCTURE FOR GASTROPARESIS

Chen Jiande, President
Transtimulation Research, Inc.city: Oklahoma City    country: United States (us)

Grant 5R43AT004489-02 from National Center For Complementary & Alternative Medicine

Abstract: 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

Keywords: Abdomen; Acupuncture Points; Acupuncture procedure; Acute; Affect; arm; base; Bilateral; Caliber; cell motility; China; Chinese Traditional Medicine; Cholecystokinin; Chronic; Clinical; Clinical Medicine; Clinical Research; Constipation; Crossover Design; design; design and construction; Development; Diabetes Mellitus; diabetic; diabetic gastroparesis; Diarrhea; Disease; Double-Blind Method; Dyspepsia; Electroacupuncture; Electrocardiogram; Electrodes; Feasibility Studies; Functional Gastrointestinal Disorders; Gastric Emptying; Gastrointestinal Hormones; Gastrointestinal Motility; Gastroparesis; General Population; ghrelin; Goals; Home environment; improved; Irritable Bowel Syndrome; Leg; Manuals; Measures; Medical; Methods; motilin; motility disorder; Nausea and Vomiting; Needles; neuropeptide Y; Non-Insulin-Dependent Diabetes Mellitus; novel strategies; Output; Pain; Pathogenesis; Patient Care; Patients; PC6 extract; Physicians; Procedures; Refractory Disease; Reporting; research study; Role; Satiation; Shapes; Skin; Solid; Stomach; Symptoms; Testing; Therapeutic; Transcutaneous Electric Nerve Stimulation; Treatment Efficacy; Vasoactive Intestinal Peptide; Visit; Wireless Technology

Relevance: 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 start date: 2009-08-01

Project end date: 2012-07-31

Budget start date: 1-AUG-2010

Budget end date: 31-JUL-2012

PFA/PA: PAR-08-135

5R43AT004489-02 (2010): $250000


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Grants awarded to Chen Jiande

EFFECTS AND MECHANISMS OF CHRONIC ELECTROACUPUNCTURE FOR EMESIS

Chen Jiande, President
University Of Texas Medical Br Galvestoncity: Galveston    country: United States (us)

Grant 5R21CA149956-02 from National Cancer Institute

Abstract: Cancer is a group of diseases characterized by uncontrolled growth and spread of abnormal cells. Over one million people get cancer each year. Approximately one out of every two American men and one out of every three American women will have some type of cancer at some point during their lifetime. Cisplatin is one of the most commonly used drugs in chemotherapy for cancers. However, severe adverse events resulting from chemotherapies, mainly nausea and vomiting may be much more distressing to a patient than future concerns of life expectancy. In fact, some patients choose to discontinue potentially curative therapy because of severe Cisplatin-induced nausea and vomiting. Antiemetic agents are the most common intervention in the management of chemotherapy-induced nausea and vomiting in cancer patients. The basis for antiemetic therapy is the neurochemical control of vomiting. However, currently, there are no satisfactory therapies for treating chemotherapy-induced emesis, especially delayed emesis. Acupuncture or electroacupuncture (EA) has been applied for treating chemotherapy-induced nausea and vomiting. A recent meta-analysis has indicated that electrical stimulation of the acupoint via inserted needles is effective in reducing acute vomiting when applied in combination with the anti-emetic medications. The long-term aim of this project is to develop an effective EA method to treat patients with chemotherapy-induced nausea and vomiting. In this project, we propose an innovative method of chronic EA delivered via chronically implanted electrodes at acupoints and an implantable pulse generator placed underneath the abdominal skin. With this new method, EA can be delivered on-demand conveniently by the patient or continuously. Systematic studies will be performed in this project to optimize the methodology of EA (best EA locations and optimal stimulation parameters). The hypothesis that chronic EA is effective in treating chemotherapy-induced emesis will be tested in a rodent model using pica (consumption of clay). Mechanistic studies will also be performed to test the hypotheses that EA is mediated via the vagal neuronal pathway and involves central neurotransmitters, dopamine and serotonin. The feasibility, safety and efficacy of chronic EA in controlling acute and delayed emesis induced by long-term cisplatin will also be investigated. A competitive team has been established, including experts in Traditional Chinese Medicine, gastrointestinal electrical stimulation, physiology of the central nervous system and medical device. Chemotherapy-induced emesis is one of major problems in the treatment of patients with cancer and occurs in more than 90% of cases with certain medications, such as Cisplatin. With the recent advancement of anti-emetic medications, acute emesis is better controlled; however, delayed emesis remains a big challenge. A novel method of chronic electroacupuncture using implantable electrodes and stimulator is proposed in this project for the treatment of chemotherapy-induced emesis. Preliminary data supports this novel concept and experiments are designed to test the feasibility of the proposed method

Keywords: Abdomen; Abnormal Cell; Acupuncture Points; Acupuncture procedure; Acute; Adverse effects; American; Animal Model; Animals; Antiemetics; Area; base; Basic Science; Brain; Cancer Patient; cancer type; Cell Nucleus; chemotherapy; Chemotherapy-Oncologic Procedure; Chinese Traditional Medicine; Chronic; Cisplatin; clay; Conscious; Consumption; Data; design; Diagnosis; Disease; Distress; Dopamine; Drug usage; Electric Stimulation; Electroacupuncture; Electrodes; Emetics; Future; gastrointestinal; Growth; Human; implantable device; implantation; Implanted Electrodes; improved; innovation; Intervention; Lead; Life Expectancy; Local anesthesia; Location; Malignant Neoplasms; Mediating; Medical Device; men; Meta-Analysis; Methodological Studies; Methodology; Methods; Nausea and Vomiting; Needles; Neuraxis; neurochemistry; Neurons; Neurotransmitters; novel; Pathway interactions; Patients; Pharmaceutical Preparations; Physiologic pulse; Physiology; Pica Disease; Procedures; public health relevance; Publishing; Rattus; research study; Rodent Model; Safety; Series; Serotonin; Severe Adverse Event; Skin; Structure of area postrema; Symptoms; Testing; Therapeutic Effect; Time; Visit; Vomiting; Woman

Relevance: Chemotherapy-induced emesis is one of major problems in the treatment of patients with cancer and occurs in more than 90% of cases with certain medications, such as Cisplatin. With the recent advancement of anti-emetic medications, acute emesis is better controlled; however, delayed emesis remains a big challenge. A novel method of chronic electroacupuncture using implantable electrodes and stimulator is proposed in this project for the treatment of chemotherapy-induced emesis. Preliminary data supports this novel concept and experiments are designed to test the feasibility of the proposed method

Project start date: 2010-07-01

Project end date: 2012-06-30

Budget start date: 1-JUL-2011

Budget end date: 30-JUN-2012

PFA/PA: PA-09-167

5R21CA149956-02 (2011): $161397