Spinal Cord Injuries, Spinal Cord Diseases
Conditions
Keywords
Trans-spinal electrical stimulation, Locomotor training, Functional electrical stimulation, Peripheral nerve stimulation
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?
Interventions
DEVICETrans-spinal electrical stimulation
Trans-spinal electrical stimulation (ts-ES) at T11-L1 vertebral levels with short pulses at a set frequency (30Hz).
DEVICEElectrical 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.
OTHERTreadmill walking
Stepping on a treadmill with individually preferred speed.
Sponsors
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactKatinka Stecina
Backup ContactKristine Cowley
Outcome results
None listed