Improving health and movement in spinal cord injury patients with exercise and stimulation
Motor and Autonomic Concomitant Health Improvements With Neuromodulation and Exercise (MACHINE) Training: A Randomized Controlled Trial in Individuals With SCI
This study is testing whether a combination of special exercise and gentle spinal stimulation can help people with spinal cord injuries improve their movement and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04726059 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of activity-based therapy (ABT) combined with non-invasive transcutaneous spinal cord stimulation (TSCS) on individuals with spinal cord injuries (SCI). The study aims to enhance motor control and autonomic functions, such as bladder and bowel control, through body-weight-supported treadmill training. Participants will engage in a randomized controlled trial to assess the effectiveness of these interventions in improving seated balance and overall health outcomes. The research focuses on individuals with chronic traumatic SCI, particularly those with complete motor paralysis at or above the T6 spinal segment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-60 with chronic traumatic spinal cord injuries at or above the T6 level, who have been stable for at least one year post-injury.
Not a fit: Patients with incomplete motor paralysis, those with recent spinal surgeries, or individuals with active infections or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and health outcomes for patients with spinal cord injuries by restoring motor and autonomic functions.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques for improving motor and autonomic functions in spinal cord injury patients, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION 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: 1. 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 2. 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 * Medication dosage must be stable for period of 4 weeks prior to participation * Must provide informed consent EXCLUSION CRITERIA 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 * Oral baclofen dose or other anti-spasticity medications greater than 30mg per day * 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 * Participant has swollen, infected, and inflamed areas or open wounds on the area of stimulation * 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
Where this trial is running
Vancouver, British Columbia
- Blusson Spinal Cord Centre — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Andrei Krassioukov, MD,PhD,FRCPC — University of British Columbia
- Study coordinator: Andrea Maharaj, BSc
- Email: amaharaj@icord.org
- Phone: 6046758856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.