Non-invasive Spinal Cord Stimulation After Spinal Cord Injury
- Conditions
- Spinal Cord InjuriesSpinal Cord Diseases
- Interventions
- Device: Trans-spinal electrical stimulationDevice: Electrical muscle activationOther: Treadmill walking
- 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?
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
- Arm && Interventions
Group Intervention Description Treadmill training combined with muscle and spinal cord stimulation Treadmill walking 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. Treadmill training combined with muscle and spinal cord stimulation Electrical muscle activation 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. Treadmill training combined with muscle and spinal cord stimulation Trans-spinal electrical 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.
- 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