Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers

Background Previous studies demonstrated that electrical stimulation in the upper abdomen inhibited postprandial antral motility, possibly through activation of somatovisceral stimulation or central mechanisms. Percutaneous electrical neurostimulation of dermatome T6 was associated with appetite reduction and, along with a proper diet, achieved a significantly greater weight reduction than diet alone in morbidly obese subjects. The effect on appetite and weight could be related to an effect on gastric motor functions. However, the effects of T6 dermatomal electrical stimulation on gastric motor functions are unclear. Hypothesis T6 dermatomal electrical stimulation treatment results in inhibition of postprandial antral motility in healthy volunteers. Aim We aim to compare measurements of postprandial antral motor activity in healthy participants treated with sham versus active T6 dermatomal electrical stimulation (delivered by a TENS unit). Methods We shall perform multilumen gastroduodenal manometry to measure postprandial antral motor activity in response to sham versus active T6 dermatomal electrical stimulation in a parallel group study design. Significance This study will form the foundation for the potential subsequent application of dermatome electrical stimulation for altering gastroduodenal motility. Title of the Study: Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers Protocol Version: 2.0 (dated 5/15/2017) Principal Investigator: Michael Camilleri, M.D. Fellow Co-investigator(s): Technician coordinators: Hoda Kadouh, Ph.D., R.D., Victor Chedid, M.D. Irene Busciglio, B.S.; Duane Burton, M.H.A.; Michael Ryks ; Deborah Eckert BSN; Kayla Arndt Statistician: Alan R. Zinsmeister, Ph.D. Camilleri et al. 2 -