Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596369
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-06
Brief Title:
Transcutaneous Spinal Cord Stimulation for Upper Extremity Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study
Status:
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:
Transcutaneous electrical stimulation tcES of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury SCI More recently the use of invasive epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke However the effect of stimulation parameters such as electrode configuration and stimulation frequency on excitability of the nervous system remains unknown preventing the opportunity to fully exploit this noninvasive stimulation paradigm Additionally the utility of noninvasive tcES in the stroke population remains unexplored This project utilizes a comprehensive set of neurophysiological techniques in combination with carefully chosen motor tasks to directly link and assess the effects of stimulation parameters on neural excitability and upper extremity function during and following the delivery of cervical tcES in individuals with SCI and stroke The fundamental knowledge gained from this project will ultimately improve the implementation of this novel and non-invasive neuromodulatory tool through an improved understanding of how tcES can facilitate recovery of function
Detailed Description:
In the first two aims of this study we explore the effects of stimulation configurations on neural excitability Specifically we will explore the effects of electrode placement and stimulation frequency on measures of corticospinal and intracortical excitability In the last aim of this study individuals will participate in an interventional trial combining activity-based therapy with tcES We will explore whether this intervention facilitated improvements in upper extremity function through clinical and neurophysiological assessments
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