Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491758
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-12
Brief Title:
ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve ABVN on Cervical Vagus Nerve Action Potentials Phase 2
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABVN2
Brief 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
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
Detailed Description:
The research described in this protocol is an extension of the investigators 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 Healthy volunteer subjects and gastroparetic subjects will be recruited and studied for this project 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
Additionally as there are currently no physiological methods that can record and measure gastric vagal activity in human subjects a separate component of this study will be to measure the gastric vagal activity in humans If the proposed study shows that it is indeed possible to record a vagal signature in response to electrical stimulation then the Investigators will conduct further investigations which examine the vagal response to other gastric stimuli
Due to the low signal-to-noise ratios observed from compound vagal nerve activity in response to GES investigators are interested in measuring the vagal response to maneuvers which are known to stimulate the vagus nerve The implementation of these vagal maneuvers will allow comparison of ABVN stimulation to traditional methods of vagal stimulation
Based on the researchers heathy volunteer study and the proposal with NIH research staff would like to propose some additional features Investigators would like to study the effect of transcutaneous stimulation of the auricular branch of the vagus nerve ABVN in gastroparetic patients with symptomatic nausea and vomiting who have not undergone gastric electrical stimulation device implantation
A total of 40 gastroparetic patients will be enrolled with 20 diabetic and 20 idiopathic patients
Also the research team propose to study the effect on gastric hormone before during and after auricular stimulation
The proposal is to enroll 30 healthy volunteers with no gastric symptoms to undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before after stimulation and later a third draw after a period of no stimulation
This is based upon the results obtained in the investigators previous IRB approved study where blood was drawn in patients who had gastric electrical stimulation device implanted Blood was drawn to study the effects of stimulation on gastric hormones Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus nerve in Patients with Gastroparesis- IRB 1206008988
The next part is also to enroll 40 gastroparetic subjects to undergo blood draw before after transcutaneous stimulation of the auricular branch of the vagus nerve and a third draw after a period of no stimulation Another part is to enroll 40 gastroparetic subjects to undergo vagal maneuver that includes food study using the bipolar EKG electrodes
Another part is to enroll 10 healthy volunteers to undergo vagal maneuver using the Multi Array Electrodes MEA
An additional 25 subjects who have no GI symptoms otherwise healthy but have undergone Vagal Nerve Stimulation VNS Therapy for the treatment of partial or focal seizures will be recruited for the study
Another proposal in the same line is using the percutaneous electrical field stimulation PENFS on vagal nerve in healthy volunteers and study the effect on the compound actions parasympathetic and sympathetic vagal nerve activity and gastric myoelectrical EGG activity A total of 24 healthy volunteers will be enrolled in this pilot study
EDS- Ehlers Danlos Syndrome The investigators preliminary data on gastroparetic subjects who had a concomitant diagnosis of EDS and have undergone the ear stimulation part of the study shows results that need to be correlated with the data from subjects who may not have gastroparesis but are diagnosed with EDS The number of subjects to date recruited who have a diagnosis of gastroparesis and EDS and have undergone ear stimulation is only two The Investigator and the research team would like to recruit subjects that have both the diagnosis of gastroparesis and EDS or EDS only to further study the effect of the stimulation on the heart rate variability A total of 60 subjects will be enrolled
The next phase of the study 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
Additionally as there are currently no physiological methods that can record and measure gastric vagal activity in human subjects a separate component of this study will be to measure the gastric vagal activity in humans If the proposed study shows that it is indeed possible to record a vagal signature in response to electrical stimulation then the Investigators will conduct further investigations which examine the vagal response to other gastric stimuli
Due to the low signal-to-noise ratios observed from compound vagal nerve activity in response to GES investigators are interested in measuring the vagal response to maneuvers which are known to stimulate the vagus nerve The implementation of these vagal maneuvers will allow comparison of ABVN stimulation to traditional methods of vagal stimulation
Based on the researchers heathy volunteer study and the proposal with NIH research staff would like to propose some additional features Investigators would like to study the effect of transcutaneous stimulation of the auricular branch of the vagus nerve ABVN in gastroparetic patients with symptomatic nausea and vomiting who have not undergone gastric electrical stimulation device implantation
A total of 40 gastroparetic patients will be enrolled with 20 diabetic and 20 idiopathic patients
Also the research team propose to study the effect on gastric hormone before during and after auricular stimulation
The proposal is to enroll 30 healthy volunteers with no gastric symptoms to undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before after stimulation and later a third draw after a period of no stimulation
This is based upon the results obtained in the investigators previous IRB approved study where blood was drawn in patients who had gastric electrical stimulation device implanted Blood was drawn to study the effects of stimulation on gastric hormones Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus nerve in Patients with Gastroparesis- IRB 1206008988
The next part is also to enroll 40 gastroparetic subjects to undergo blood draw before after transcutaneous stimulation of the auricular branch of the vagus nerve and a third draw after a period of no stimulation Another part is to enroll 40 gastroparetic subjects to undergo vagal maneuver that includes food study using the bipolar EKG electrodes
Another part is to enroll 10 healthy volunteers to undergo vagal maneuver using the Multi Array Electrodes MEA
An additional 25 subjects who have no GI symptoms otherwise healthy but have undergone Vagal Nerve Stimulation VNS Therapy for the treatment of partial or focal seizures will be recruited for the study
Another proposal in the same line is using the percutaneous electrical field stimulation PENFS on vagal nerve in healthy volunteers and study the effect on the compound actions parasympathetic and sympathetic vagal nerve activity and gastric myoelectrical EGG activity A total of 24 healthy volunteers will be enrolled in this pilot study
EDS- Ehlers Danlos Syndrome The investigators preliminary data on gastroparetic subjects who had a concomitant diagnosis of EDS and have undergone the ear stimulation part of the study shows results that need to be correlated with the data from subjects who may not have gastroparesis but are diagnosed with EDS The number of subjects to date recruited who have a diagnosis of gastroparesis and EDS and have undergone ear stimulation is only two The Investigator and the research team would like to recruit subjects that have both the diagnosis of gastroparesis and EDS or EDS only to further study the effect of the stimulation on the heart rate variability A total of 60 subjects will be enrolled
The next phase of the study 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None