Motor and Autonomic Concomitant Health Improvements With Neuromodulation and Exercise Training: A RCT in Individuals With SCI (MACHINE)
Spinal Cord Injuries, Neurogenic Bladder, Neurogenic Bowel
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Activity-based Therapy, Spinal Cord Stimulation, Transcutaneous Spinal Cord Stimulation
Eligibility Criteria
A participant must meet all of the following criteria in order to be eligible for inclusion:
- Resident of British Columbia, Canada with active provincial medical services plan
- Male or female, 18-60 years of age
- Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment
- At least 1-year post injury, at least 6 months from any spinal surgery
- American Spinal Injury Association Impairment Scale (AIS) A, B
- Able to tolerate an upright posture for 30 minutes (with or without breaks)
- Willing and able to comply with all clinic visits and study-related procedures
- Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator)
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities
- Stable management of spinal cord related clinical issues (i.e., spasticity management)
Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events
- Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence
- Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment
- Must provide informed consent
A participant who meets any of the following criteria will be ineligible to participate:
- Ventilator dependent
- Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse
- Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study
- Intrathecal baclofen pump
- Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones
- Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications [tricyclics], debilitating muscle pain, pressure sores, or unstable diabetes
- Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk
- History of osteoporosis, low bone mineral density, or fragility fractures in the lower limbs
- History of seizures/epilepsy or recurring headaches
- Poor range of motion,severe spasticity, or contractures in the legs that prevents use of the Lokomat
- Weight greater than 136 kg, height less than 1.58m, or height greater than 1.88m (limits of the Lokomat)
- Severe anemia (Hgb<8 g/dl) or hypovolemia as measured by hematocrit via blood test in the last six months
- Participant is a member of the investigational team or his /her immediate family
- Participant has undergone electrode implantation surgery
Sites / Locations
- Blusson Spinal Cord CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
ABT+SHAM
ABT+TSCS
The SHAM is low-intensity, ineffective stimulation delivered at the same anatomical location as TSCS.
Therapeutic TSCS will be delivered during ABT using an isolated bipolar constant current stimulator. Continuous TSCS applied over the T11-T12 spinous processes at 5-40 Hz has been shown to induce stepping movements in participants with their legs in a gravity-independent position.