Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04132596
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2019-10-17
Brief Title:
Spinal Stimulation in Chronic Spinal Cord Injury
Sponsor:
The Neurokinex Charitable Trust
Organization:
The Neurokinex Charitable Trust
Study Overview
Official Title:
Non-invasive Spinal Cord Stimulation Combined With Activity-based Rehabilitation in Chronic Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Electrical spinal stimulation combined with activity-based rehabilitation ABR can improve motor and autonomic function in individuals suffering from varying degrees of paralysis Spinal stimulation studies have included invasive implanted devices and non-invasive transcutaneous systems using different combinations of stimulation current waveform amplitude duration and spinal levels targeted Invasive and non-invasive systems have been demonstrated to permit individuals with chronic spinal cord injury SCI previously considered to have complete injuries on the International Standards for the Neurological Classification of Spinal Cord Injuries ISNCSCI scale Classification A to regain some degree of voluntary and autonomic function during periods of stimulation The aim of this study is to evaluate the effects of a novel non-invasive transcutaneous electrical spinal cord stimulation system tSCS combined with activity-based rehabilitation in patients who have paralysis of their legs andor arms We will examine participants for any changes in sensory motor or autonomic function We will use a transcutaneous spinal cord stimulator that has been designed to deliver safe and tolerable bursts of high frequency pulsed current that minimise the capacitance efforts of the skin surface and maximise conductance of a second waveform using low frequency current to target neural structures We aim to investigate this form of neuromodulation with a small group of individuals with chronic spinal cord injury Our goal is to observe and describe any short term or lasting changes in function that can safely and comfortably be derived from this combination of spinal stimulation and activity-based rehabilitation If this therapy can cause lasting improvements in sensory motor respiratory or autonomic function then this may lead to a greater degree of functional independence for these individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None