ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
NCT Number: NCT06491758
Acronym: ABVN2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastroparesis
Interventions: OTHER: abvn|OTHER: PENFS- Percutaneous Electrical Nerve Field Stimulation|DEVICE: wrist worn Corsano Cardio Watch 287-2B)-|DEVICE: Gastroelectric Stimulator (GES)|DEVICE: TaVNS (Transcutaneous Auricular Vagal Nerve Stimulation) Device
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 330
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2020-06-02
Completion Date: 2030-12
Locations: Indiana University, Indianapolis, Indiana, 46202, United States

Summary:
The research described in this protocol is an extension of current protocols which is designed to measure cervical compound vagal nerve action potentials in patients who have an implanted gastric electrical stimulation device (IRB# 1206008988) and also the protocol to measure the effect of ABVN stimulation and vagal maneuvers in healthy volunteers.

Volunteer subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN) to determine whether this modality will also produce cervical vagus nerve compound action potentials and changes in the gastric hormones. Gastroparetic subjects who have not had a gastric stimulator placed will also undergo the ABVN stimulation to look for changes in vagal nerve CNAPs and gastric hormones.

Primary Outcome Measures: To assess how various types of stimulation affect bodily systems and blood serum levels., Investigators hope to measure the activity of the vagus nerve when stimulated in several ways and to measure the activity of the heart and vagus nerve in volunteers. This may help researchers determine if heart rate is affected by VNS therapy. Investigators will use ECG/ EGG electrodes, a pneumatic chest belt (for measuring breathing depth and rate), Percutaneous Electrical Nerve Field Stimulator, Transcutaneous auricular Vagus Nerve Stimulation, and a wearable cardiowatch/bracelet for monitoring autonomic and sympathetic system patterns and use blood draws to search for changes in serum levels before, during and after stimulations, Two Years|To assess participant autonomic responses to mild transcutaneous auricular vagus nerve stimulation (taVNS), TaVNS, will be used to assess Heart Rate Variants, and pattern changes in the participant's autonomic responses to the external stimuli in the left ear. These will be recorded in the form of an EKG with electrodes placed under the clavicle of the right and left sides of the chest and on the vagal nerve and jugular vein on either side of the subject's neck., Two Years
Secondary Outcome Measures: To measure respiratory changes in heart rate during ABVN and also during the vagal maneuvers phase., To measure respiratory changes in heart rate during ABVN and during the vagal maneuvers using skin electrodes over right and left vagus nerve, via EKG during ABVN stimulation and also during the vagal maneuvers phase., Two Years|measure changes in the amplitude of the surface electrogastrogram during ABVN, To measure changes in the amplitude of the surface electrogastrogram with skin electrodes over right and left vagus nerve during ABVN and also during the vagal maneuvers phase., Two Years|To measure the Heart rate variability (HRV), vagal nerve compound action potentials and in subjects undergoing VNS Therapy, Using skin electrodes for an EKG over right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase in patients being treated for Focal/partial seizures., Two Years|To measure the effect of ABVN stimulation on the gastric hormones in healthy and gastroparetic subjects., In gastroparetic subjects and healthy volunteers; blood draws will be done at a baseline time point, after stimulation to the ABVN in healthy patients and after turning the gastric stimulator off in patients with gastroparesis, and then after a recovery period for both groups. The blood will then be processed into serum and that serum will then be tested by an Indiana University Lab to determine changes in Insulin, Glucose and C-peptide levels after each phase., Two Years|measure the amplitude of vagal nerve compound action potentials in healthy volunteers undergoing PENFS, To measure the amplitude of vagal nerve compound action potentials in healthy volunteers undergoing PENFS, Two years|measure the parasympathetic and sympathetic vagal nerve activity in healthy volunteers undergoing PENFS, To measure the parasympathetic and sympathetic vagal nerve activity in healthy volunteers undergoing PENFS, Two Years|measure the changes in the amplitude of the surface electrogastrogram (EGG), o measure the changes in the amplitude of the surface electrogastrogram (EGG) in healthy volunteers after PENFS, Two Years|ssess if the wearable device can predict/detect the onset of symptoms reported by study participants wearing the wrist watch, The investigators will use the Corsano watch/bracelet To assess if the wearable device can predict/detect the onset of symptoms reported by study participants wearing the wrist watch. The Coordinators will have access to Corsano's data base function to monitor information and usage of the Corsano bracelet, Two Years|To assess participant autonomic responses to taVNS stimulation., In order to assess participant autonomic responses to taVNS stimulation, skin electrodes will be placed over the right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase. This will give an EKG type of readout which will be used to determine changes in biometric functions during the assessment., Two Years|measure the amplitude of vagal nerve compound action potentials in gastroparetic subjects, To measure the amplitude of vagal nerve compound action potentials in gastroparetic subjects with symptoms of nausea and vomiting with skin electrodes over right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase, Two Years
Other Outcome Measures: The investigators would like to study the autonomic responses for EDS patients and matched controls using wearable watch device and transcutaneous stimulation of the auricular branch of the vagal nerve stimulation (TaVNS), Investigators will be studying the autonomic responses for EDS patients and matched controls using wearable watch device after transcutaneous stimulation of the auricular branch of the vagal nerve stimulation (TaVNS). This device will be used to gather daily information from various autonomic and sympathetic biometric functions over the course of one month. The readings will then be assessed by Purdue University biostatisticians to detect patterns and variants in the different functions., Two Years