Recruiting

Spinal Cord Stimulation

Sponsor:

University of Manitoba

Code:

NCT06260735

Conditions

Spinal Cord Injuries

Spinal Cord Diseases

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Trans-spinal electrical stimulation

Electrical muscle activation

Treadmill walking

Study Details

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.

Conditions

Spinal Cord Injuries

Spinal Cord Diseases

Study ID

NCT06260735

Start date

Jun 15, 2023

Status verified date

Feb, 2024

Completion date

Nov 15, 2024

Anticipated

Primary completion date

Aug 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Treadmill walking

Stepping on a treadmill with individually preferred speed.

Primary outcome measure

  • Neurophysiological markers or stepping [ Time Frame: Pre-training (on week 1) and within one week from end of training (on week 6) ]
  • Electromyography (EMG) of ankle extensor muscles [ Time Frame: Pre-training (on week 1) and within one week from end of training (on week 6) ]
  • Metabolic function testing [ Time Frame: Pre-training (on week 1) and within one week from end of training (on week 6) ]

Central Contacts and Locations

Central contacts

Katinka Stecina

204-789-3761katinka.stecina@umanitoba.ca

Kristine Cowley

204-789-3305kristine.cowley@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0W2

Contacts

Katinka Stecina

204-789-3761katinka.stecina@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Feb 15, 2024

Last verified

Feb, 2024

Keywords

  • Trans-spinal electrical stimulation
  • Locomotor training
  • Functional electrical stimulation
  • Peripheral nerve stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2024-02-15.