Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Optimization of Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
Status:
NOT_YET_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:
None
Brief Summary:
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation scTS to improve hand function in children with spinal cord injuries SCI The investigators will start by exploring the best places and strengths for applying scTS on the neck the added benefits of applying scTS on the lower back T11-T12 and comparing the effects of using activity based upper extremity training a control treatment alone versus combining it with scTS to help children with chronic SCI regain hand function
Detailed Description:
After learning about the study and potential risks parentslegal guardians and their eligible children with SCI will sign consent and assent forms respectively For the first two aims of the study the investigators will recruit and enroll 10 participants In the first week participants will undergo clinical assessments from day 1 to day 4 to categorize the severity and level of their injuries and assess their current arm and hand function On day 5 eligible participants will have experimental assessments to measure hand grip and control both with and without spinal cord stimulation scTS at one or two neck sites optimized to improve hand grip On day 6 participants will have similar assessments this time adding stimulation to the trunk area to help with upright sitting and study its impact on hand grip and control
For the third aim 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come first-served basis They will undergo 20 sessions of activity-based upper extremity training followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2 After completing the training participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last
For the third aim 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come first-served basis They will undergo 20 sessions of activity-based upper extremity training followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2 After completing the training participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None