Clinical trial NCT06260735: Non-invasive Spinal Cord Stimulation After Spinal Cord Injury
Official title: Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: Trans-spinal electrical stimulation
Locomotor training
Functional electrical stimulation
Peripheral nerve stimulation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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?

Eligibility criteria: 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.)

Primary outcomes:
measure: Neurophysiological markers or stepping
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
measure: Electromyography (EMG) of ankle extensor muscles
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
measure: Metabolic function testing
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
Secondary outcomes:
measure: 6 Min Walk Test
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
measure: SCIM-Spinal Cord Independence Measure- Mobility scores
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
measure: Autonomic scores
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
measure: Rate or Perceived Exertion (RPE) of Submaximal VO2 testing
timeFrame: Pre-training (on week 1) and within one week from end of training (on week 6)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Katinka Stecina
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Kristine Cowley
role: PRINCIPAL_INVESTIGATOR
References: