Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

NCT06260735 | Recruiting

• 3 other identifiers: HS25897 (H2023:073)URGP#51472RGPIN-2015-05703
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 6 Min Walk Test

  Pre-training (on week 1) and within one week from end of training (on week 6)

• SCIM-Spinal Cord Independence Measure- Mobility scores

  Pre-training (on week 1) and within one week from end of training (on week 6)

• Autonomic scores

  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

  Pre-training (on week 1) and within one week from end of training (on week 6)

Study Arms (1)

Treadmill training combined with muscle and spinal cord stimulation

EXPERIMENTAL

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; Device: Electrical muscle activation; Other: Treadmill walking

Interventions

Trans-spinal electrical stimulation DEVICE

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

Treadmill training combined with muscle and spinal cord stimulation

Electrical muscle activation DEVICE

Peripheral nerve (PN) or muscle (NMES) stimulation strategy was developed for each participant to optimize stance/walk capacity based on personal needs/preferences.

Treadmill training combined with muscle and spinal cord stimulation

Treadmill walking OTHER

Stepping on a treadmill with individually preferred speed.

Treadmill training combined with muscle and spinal cord stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0W2, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Katinka Stecina

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Kristine Cowley

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katinka Stecina

CONTACT

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

Kristine Cowley

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: February 15, 2024
• Study Start: June 15, 2023
• Primary Completion: August 15, 2024
• Study Completion: November 15, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)