Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Last updated: February 14, 2024
Sponsor: University of Manitoba
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Spinal Cord Disorders

Treatment

Treadmill walking

Electrical muscle activation

Trans-spinal electrical stimulation

Clinical Study ID

NCT06260735
HS25897 (H2023:073)
URGP#51472
RGPIN-2015-05703
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, severehypertension etc.)

Study Design

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: Treadmill walking
Phase:
Study Start date:
June 15, 2023
Estimated Completion Date:
November 15, 2024

Study 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?

Connect with a study center

  • University of Manitoba

    Winnipeg, Manitoba R3E 0W2
    Canada

    Active - Recruiting

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