Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06260735
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Spinal Cord Stimulation After Spinal Cord Injury
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training
Status:
RECRUITING
Status Verified Date:
2024-02
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:
SCI-ES-WALK
Brief Summary:
Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.
This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.
This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.
Detailed Description:
This project will evaluate the effects of non-invasive lumbar ts-ES on locomotor function in people with incomplete motor SCI (iSCI) who retain some ability to stand or walk.
This study has 3 phases:
Baseline assessment - 2 sessions - week 1 -Lab visits #1-2
Locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)
End of training assessment - 2 sessions - week 6- Lab visits #15-16.
Specific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. After augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-ES. The locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation.
Specifically, the project aims to assess the following:
1. Does combined muscle (NMES) or peripheral nerve (PN) stimulation with ts-ES during treadmill stepping facilitate locomotor performance?
2. Does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal VO2) in persons with chronic iSCI?
This study has 3 phases:
Baseline assessment - 2 sessions - week 1 -Lab visits #1-2
Locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)
End of training assessment - 2 sessions - week 6- Lab visits #15-16.
Specific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. After augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-ES. The locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation.
Specifically, the project aims to assess the following:
1. Does combined muscle (NMES) or peripheral nerve (PN) stimulation with ts-ES during treadmill stepping facilitate locomotor performance?
2. Does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal VO2) in persons with chronic iSCI?
Study Oversight
Has Oversight DMC:
False
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?: