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Clinical Trials/NCT06260735
NCT06260735
Recruiting
Not Applicable

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

University of Manitoba1 site in 1 country10 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
University of Manitoba
Enrollment
10
Locations
1
Primary Endpoint
Metabolic function testing
Status
Recruiting
Last Updated
2 years ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
November 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katinka Stecina

Associate Professor

University of Manitoba

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.)

Outcomes

Primary Outcomes

Metabolic function testing

Time Frame: Pre-training (on week 1) and within one week from end of training (on week 6)

Breath-by-breath analysis of air in/out will be used to measure VO2max (mL/kg/min).

Electromyography (EMG) of ankle extensor muscles

Time Frame: Pre-training (on week 1) and within one week from end of training (on week 6)

Mean RMS amplitude

Neurophysiological markers or stepping

Time Frame: Pre-training (on week 1) and within one week from end of training (on week 6)

Average step length, step height at ankle (cm).

Secondary Outcomes

  • 6 Min Walk Test(Pre-training (on week 1) and within one week from end of training (on week 6))
  • Rate or Perceived Exertion (RPE) of Submaximal VO2 testing(Pre-training (on week 1) and within one week from end of training (on week 6))
  • SCIM-Spinal Cord Independence Measure- Mobility scores(Pre-training (on week 1) and within one week from end of training (on week 6))
  • Autonomic scores(Pre-training (on week 1) and within one week from end of training (on week 6))

Study Sites (1)

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