Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456385
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-04
Brief Title:
Post-stroke Pain taVNS
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation taVNS in Patients With Chronic Post-stroke Upper Extremity Pain
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation taVNS can change the way participants perceive pain Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain The goal is to determine if there is a pain reduction after ear stimulation
Detailed Description:
In this study investigators main goal is to establish transcutaneous auricular vagus nerve stimulation taVNS as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain Each participant will undergo an in-person visit Participants will first finish the pain questionnaires and have quantitative sensory testing QST conducted to determine baseline pain thresholds Participants will then receive 30 minutes of taVNS either active or sham Upon the completion of the stimulation intervention participants will then be tested for another QST and pain questionnaires
Aim 1 Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain
Over the last 8 years investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies Specifically investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial In this study investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain
Aim 2 Investigate whether taVNS can modulate pain in this population compared to sham
In this single-visit double-blinded sham-controlled pilot trial investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention as well as between active and sham taVNS The findings will help investigators understand whether taVNS can modulate pain in this population
Aim 1 Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain
Over the last 8 years investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies Specifically investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial In this study investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain
Aim 2 Investigate whether taVNS can modulate pain in this population compared to sham
In this single-visit double-blinded sham-controlled pilot trial investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention as well as between active and sham taVNS The findings will help investigators understand whether taVNS can modulate pain in this population
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?:
True
Is an FDA AA801 Violation?:
None