Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597149
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Effect of Transcutaneous Auricular Vagus Nerve Stimulation taVNS on Plasma Insulin Levels
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Transcutaneous Auricular Vagus Nerve Stimulation taVNS on Plasma Insulin Levels
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TaVNS
Brief Summary:
The purpose of this study is to find out if investigators can stimulate the vagus nerve a nerve in the body that runs from your brain to the large intestine and influence insulin C-peptide and glucose levels C-peptide is a substance that is created when insulin is produced and released into the body The vagus nerve is a largely internal nerve that controls many bodily functions including stomach function
Investigators hope that by stimulating the vagal nerve using the TeNS behind the ear this stimulation can affect insulin levels and this will help innovate treatment of patients with nausea vomiting and disordered stomach function and patients with diabetes
Researchers hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways This could help investigators learn more about studying this nerve in the future
Investigators hope that by stimulating the vagal nerve using the TeNS behind the ear this stimulation can affect insulin levels and this will help innovate treatment of patients with nausea vomiting and disordered stomach function and patients with diabetes
Researchers hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways This could help investigators learn more about studying this nerve in the future
Detailed Description:
STUDY OBJECTIVES
Primary The research described in this protocol is best described as an extension of the researchers current protocol which is designed to measure cervical compound vagal nerve action potentials in patients who have an implanted gastric electrical stimulation device GESD The difference is that only healthy volunteer subjects will be recruited and studied and rather than undergoing gastric electrical stimulation GES volunteer subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve taVNS to determine whether this modality will also influence plasma insulin C-peptide and glucose levels While not a part of the current proposal if the results of this study are promising we anticipate applying electrical stimulation of the ABVN in future studies of gastroparetic patients with symptomatic nausea and vomiting
Secondaryexploratory If taVNS proves to have an effect on circulating plasma insulin levels then a secondary component of this study is to determine which subject variables age gender BMI may influence this response While not formally a part of this proposal investigators anticipate future studies will be designed to determine the optimal stimulus parameters stimulus current frequency pulse duration needed to produce this effect Researchers previous investigation using percutaneous electrical nerve field stimulation PENFS have shown that this modality affects the sympathetic and parasympathetic controls or heart rate variability The current proposal will also determine whether the same effect occurs with transcutaneous auricular vagus nerve stimulation taVNS
SPECIFIC AIM 1
To determine if acute taVNS stimulation of the cymba concha area of the external ear in human subjects affects plasma insulin C-peptide and glucose levels
Investigators preliminary studies show that electrical stimuli applied to electrodes implanted in the serosa of the stomach augment plasma insulin levels in humans Presumably this is due activation of sympathetic and parasympathetic nerves which also innervate the pancreas Researchers propose to non-invasively access the vagus nerve by applying electrical stimuli to the cymba concha area of the human external ear This area is innervated by the cutaneous branch of the vagus nerve which in turn sends branches to the sensory nucleus of the vagus nerve the nucleus tractus solitarius which then sends nerve fibers throughout the brainstem to control autonomic function throughout the autonomic nervous system
SPECIFIC AIM 2
To determine if acute taVNS of the cymba concha area of the external ear affects heart rate variability in human subjects
Heart rate variability is governed by parasympathetic and sympathetic nerves By using frequency-domain and time domain analysis it is possible to determine whether 1 taVNS activates the auricular branch of the vagus nerve and 2 whether any observed effects are mediated through the parasympathetic andor sympathetic autonomic nervous system
SPECIFIC AIM 3
To determine if the changes in plasma insulin C-peptide or glucose levels are associated with corresponding changes in parasympathetic or sympathetic activation
By using frequency-domain and time-domain analysis of heart rate variability it is possible to determine whether any observed changes are due to activation of parasympathetic or sympathetic nervous system or a combination of both Some subjects may show a greater change in plasma insulin C-peptide or glucose levels than others during taVNS Researchers propose to determine whether these changes are mirrored by corresponding alterations in parasympathetic and sympathetic nervous system activity
Primary The research described in this protocol is best described as an extension of the researchers current protocol which is designed to measure cervical compound vagal nerve action potentials in patients who have an implanted gastric electrical stimulation device GESD The difference is that only healthy volunteer subjects will be recruited and studied and rather than undergoing gastric electrical stimulation GES volunteer subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve taVNS to determine whether this modality will also influence plasma insulin C-peptide and glucose levels While not a part of the current proposal if the results of this study are promising we anticipate applying electrical stimulation of the ABVN in future studies of gastroparetic patients with symptomatic nausea and vomiting
Secondaryexploratory If taVNS proves to have an effect on circulating plasma insulin levels then a secondary component of this study is to determine which subject variables age gender BMI may influence this response While not formally a part of this proposal investigators anticipate future studies will be designed to determine the optimal stimulus parameters stimulus current frequency pulse duration needed to produce this effect Researchers previous investigation using percutaneous electrical nerve field stimulation PENFS have shown that this modality affects the sympathetic and parasympathetic controls or heart rate variability The current proposal will also determine whether the same effect occurs with transcutaneous auricular vagus nerve stimulation taVNS
SPECIFIC AIM 1
To determine if acute taVNS stimulation of the cymba concha area of the external ear in human subjects affects plasma insulin C-peptide and glucose levels
Investigators preliminary studies show that electrical stimuli applied to electrodes implanted in the serosa of the stomach augment plasma insulin levels in humans Presumably this is due activation of sympathetic and parasympathetic nerves which also innervate the pancreas Researchers propose to non-invasively access the vagus nerve by applying electrical stimuli to the cymba concha area of the human external ear This area is innervated by the cutaneous branch of the vagus nerve which in turn sends branches to the sensory nucleus of the vagus nerve the nucleus tractus solitarius which then sends nerve fibers throughout the brainstem to control autonomic function throughout the autonomic nervous system
SPECIFIC AIM 2
To determine if acute taVNS of the cymba concha area of the external ear affects heart rate variability in human subjects
Heart rate variability is governed by parasympathetic and sympathetic nerves By using frequency-domain and time domain analysis it is possible to determine whether 1 taVNS activates the auricular branch of the vagus nerve and 2 whether any observed effects are mediated through the parasympathetic andor sympathetic autonomic nervous system
SPECIFIC AIM 3
To determine if the changes in plasma insulin C-peptide or glucose levels are associated with corresponding changes in parasympathetic or sympathetic activation
By using frequency-domain and time-domain analysis of heart rate variability it is possible to determine whether any observed changes are due to activation of parasympathetic or sympathetic nervous system or a combination of both Some subjects may show a greater change in plasma insulin C-peptide or glucose levels than others during taVNS Researchers propose to determine whether these changes are mirrored by corresponding alterations in parasympathetic and sympathetic nervous system activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None