Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616831
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
At-Home TaVNS - Stroke Rehab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits
Detailed Description:
This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation taVNS paired with motor rehabilitation to improve motor function post-stroke Early evidence from a recently completed NIH-funded clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve
This project takes this approach one step further moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas In order to accomplish this investigators will a conduct lab-based testing and validation of the stimulation triggering sensors for at-home use and b determine the safety feasibility and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits
Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention Furthermore investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting Lastly investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials
This project takes this approach one step further moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas In order to accomplish this investigators will a conduct lab-based testing and validation of the stimulation triggering sensors for at-home use and b determine the safety feasibility and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits
Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention Furthermore investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting Lastly investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials
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