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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Diseases; Spinal Cord Injuries
• Intervention / Treatment: Device: Trans-spinal electrical stimulation; Device: Electrical muscle activation; Other: Treadmill walking

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?

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katinka Stecina; Phone Number: 204-789-3761; Email: katinka.stecina@umanitoba.ca
• Study Contact Backup: Name: Kristine Cowley; Phone Number: 204-789-3305; Email: kristine.cowley@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0W2
      • Recruiting
      • University of Manitoba
      • Contact: Katinka Stecina; Phone Number: 204-789-3761; Email: katinka.stecina@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treadmill training combined with muscle and spinal cord stimulation; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiological markers or stepping	Average step length, step height at ankle (cm).	Pre-training (on week 1) and within one week from end of training (on week 6)
Electromyography (EMG) of ankle extensor muscles	Mean RMS amplitude	Pre-training (on week 1) and within one week from end of training (on week 6)
Metabolic function testing	Breath-by-breath analysis of air in/out will be used to measure VO2max (mL/kg/min).	Pre-training (on week 1) and within one week from end of training (on week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Min Walk Test	Measure distance (m) covered in 6 min walking, overground with device of choice (if using it at home/in community). Repeat with save device. Verbal encouragement and safety support in place during testing.	Pre-training (on week 1) and within one week from end of training (on week 6)
SCIM-Spinal Cord Independence Measure- Mobility scores	Rick Hansen Institute, Spinal Cord Independence Measure III - Mobility subsection, Questions 12-17. Scale: 0-20. Lower score means less mobility.	Pre-training (on week 1) and within one week from end of training (on week 6)
Autonomic scores	American Spinal Injury Association-Autonomic Standards assessment form-General Autonomic Function & Lower Urinary tract, bowel, and sexual function components. Scale: 0-48. Lower scores mean less autonomic function.	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	Borg scale from 6-20 (chart used from Heart Online open source). Scale: 6-20. Lower scores mean less exertion (less tiring).	Pre-training (on week 1) and within one week from end of training (on week 6)

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Katinka Stecina, University of Manitoba; Principal Investigator: Kristine Cowley, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Functional electrical stimulation; Locomotor training; Peripheral nerve stimulation; Trans-spinal electrical stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: HS25897 (H2023:073); URGP#51472 (Other Grant/Funding Number: University of Manitoba); RGPIN-2015-05703 (Other Grant/Funding Number: NSERC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No