Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— SCI-ES-WALK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260735
• Other study ID #: HS25897 (H2023:073)
• Secondary ID: URGP#51472RGPIN-
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: University of Manitoba
• Contact: Katinka Stecina
• Phone: 204-789-3761
• Email: katinka.stecina[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries

Intervention

Device:
• Trans-spinal electrical stimulation
Trans-spinal electrical stimulation (ts-ES) at T11-L1 vertebral levels with short pulses at a set frequency (30Hz).
• 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.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)