NCT06260735

Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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?

Conditions

• Spinal Cord Injuries
• Spinal Cord Diseases

Interventions

Type	Name	Description
DEVICE	Trans-spinal electrical stimulation	Trans-spinal electrical stimulation (ts-ES) at T11-L1 vertebral levels with short pulses at a set frequency (30Hz).
DEVICE	Electrical muscle activation	Peripheral nerve (PN) or muscle (NMES) stimulation strategy was developed for each participant to optimize stance/walk capacity based on personal needs/preferences.
OTHER	Treadmill walking	Stepping on a treadmill with individually preferred speed.

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-08-15
• Completion: 2024-11-15
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

1 site across 1 country: Canada