The controlled clinical trial at the First Affiliated Hospital of Nanjing Medical University Department of Gastroenterology by principal investigator Hongjie Zhang, M.D., a gastroenterologist, is designed to try to reduce the inflammatory response underlying the chronic gastrointestinal disorder.
The study recruited 17 Crohn’s disease patients and 20 matched healthy controls between June 2014 and December 2014. The patients receive transdermal acupoint electrical stimulation (TAES) for an hour twice a day, two hours after a meal, at an acupoint on the stomach meridian below the knee – the Zusanli (ST 36).
The study was initially suggested to Zhang by Jiande Chen, Ph.D. of the Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore.
“We have published numerous studies showing that electrical stimulation via the acupuncture points using surface electrodes can enhance vagal activity,” he commented. “By enhancing vagal activity, we have shown in animals with intestinal inflammation that such electrical stimulation can suppress pro-inflammatory cytokines and thus reduce inflammation.” Those data are being prepared for publication.
In the clinical study, the patients receive the electrical stimulation through a watch-sized stick-on device, powered by a watch battery. The needle-less stimulation device can deliver a variety of stimulation digitally, and was developed by Chen through a grant from the National Institutes of Health.
For the first three days, stimulation is administered at the hospital, and then the patients are instructed in use of the stimulator and sent home with a photo to help them identify the acupoint.
The patients are evaluated at 3 days, 14 days, and 30 days. Based on data from an initial 17 patients after 3 days of stimulation sessions, Zhang said an imbalance between the sympathetic and parasympathetic branches of the autonomic nervous system was evident.
Crohn’s disease activity index (CDAI) scores are taken at each evaluation. The index tracks abdominal pain, diarrhea, physical signs (i.e. average daily temperature, abdominal mass), medication use (i.e. loperamide or opiate use for diarrhea), laboratory results (such as hematocrit) and body weight.
The research team also gathers blood and stool samples to assess levels of pro-inflammatory cytokines and gut hormones that are biomarkers of inflammation or autonomic nervous system imbalance. The effect of stimulation on autonomic nervous system balance is also non-invasively evaluated by analyzing heart rate variability.
Additional co-authors include Jingjing Ma, M.D. and Jiewen Su, M.D., who are contributing to the sample collection, TAES investigation, and data analysis at the First Affiliated Hospital of Nanjing Medical University. Professor Chen helped with the study design and is providing the TAES device. Dr. Zhang conceived the study and designed and supervised the experiments. The study was supported in part by the Key Medical Personnel of Jiangsu Province (no. RC2011063).
“We really expect CDAI to go down after chronic TAES,” Zhang commented.###
About the International Neuromodulation SocietyThe International Neuromodulation Society (INS) is a nonprofit medical society that unites clinicians, scientists and engineers to share scientific knowledge about all aspects of neuromodulation in order to encourage best medical practice. Founded in 1989 and based in San Francisco, CA, the INS presents up-to-date information about the full breadth of neuromodulation therapies through an interactive website at http://www.neuromodulation.com, chapter scientific meetings, the MEDLINE-indexed journal Neuromodulation: Technology at the Neural Interface, and its biennial world congress.
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