Non-invasive Spinal Cord Stimulation After Spinal Cord Injury (SCI-ES-WALK)

University of Manitoba

Status: Enrolling

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Treatments: Device: Electrical muscle activation; Device: Trans-spinal electrical stimulation; Other: Treadmill walking

Study type: Interventional

Funder types: Other

Identifiers

NCT06260735

HS25897 (H2023:073)

RGPIN-2015-05703 (Other Grant/Funding Number)

URGP#51472 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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?

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has spinal cord injury, 6 mo or longer since injury
• Is between 20 and 65 years of age
• Has difficulty with trunk and/or lower limb function
• Stable medical condition
• Non-progressive etiology of spinal injury
• No ventilatory support

Exclusion criteria

• Genetic or degenerative etiology of spinal injury
• Need for ventilatory or other life-sustaining medical support
• History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Treadmill training combined with muscle and spinal cord stimulation

Experimental group

Description:

Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating.

Treatment:

Other: Treadmill walking

Device: Electrical muscle activation

Device: Trans-spinal electrical stimulation