Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Spinal Cord Diseases

• Registration Number: NCT06260735
• Lead Sponsor: University of Manitoba

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?

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2023-11-28
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-08-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Metabolic function testing	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	Pre-training (on week 1) and within one week from end of training (on week 6)	Mean RMS amplitude
Neurophysiological markers or stepping	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 Outcome Measures

Name	Time	Method
6 Min Walk Test	Pre-training (on week 1) and within one week from end of training (on week 6)	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.
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)	Borg scale from 6-20 (chart used from Heart Online open source). Scale: 6-20. Lower scores mean less exertion (less tiring).
SCIM-Spinal Cord Independence Measure- Mobility scores	Pre-training (on week 1) and within one week from end of training (on week 6)	Rick Hansen Institute, Spinal Cord Independence Measure III - Mobility subsection, Questions 12-17. Scale: 0-20. Lower score means less mobility.
Autonomic scores	Pre-training (on week 1) and within one week from end of training (on week 6)	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.

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada