Motor & Autonomic Concomitant Health Improvements With Neuromodulation & Exercise Training: An SCI RCT
Motor and Autonomic Concomitant Health Improvements With Neuromodulation and Exercise (MACHINE) Training: A Randomized Controlled Trial in Individuals With SCI
University of British Columbia
12 participants
Jul 22, 2022
INTERVENTIONAL
Conditions
Summary
Spinal cord injury (SCI) disrupts many aspects of life, including the loss of volitional movement and involuntary control of bodily functions; both crucial functional recovery priorities for this population. Mobility impairments and secondary complications limit an individual's ability to exercise, a behavior known to have wide-ranging functional and health benefits. This trial will investigate whether activity-based therapy (ABT), using body-weight-supported treadmill training (BWSTT), can change the strength of signals from the brain that control volitional movement, leading to improvements in seated balance as well as other important involuntary bodily (i.e. cardiovascular, urinary tract, bowel and sexual) functions. The investigators aim to determine whether these improvements can be augmented with the addition of non-invasive transcutaneous spinal cord stimulation (TSCS). This therapy has been shown to re-awaken dormant spinal circuits. In this randomized controlled trial, TSCS with ABT, using BWSTT (three sessions/week for twelve weeks), will be compared to ABT+SHAM in individuals with chronic motor-complete spinal cord injury (SCI). Those in the ABT+SHAM group will be given the option to complete an ABT+TSCS open-label follow-up. Before and after training, the following outcomes will be assessed by validated methods: corticospinal excitability, motor function, and seated balance (Hypothesis 1 - Motor Function); severity and frequency of blood pressure instability, urinary tract, bowel, and sexual dysfunctions (Hypothesis 2 - Autonomic Functions); and general health (Hypothesis 3 - Quality of Life). This collaborative project is between consumers with SCI and clinicians/scientists with expertise in SCI care (kinesiologists, physiotherapists, physiatrists, sexual health clinicians). Compared to ABT alone, the investigators anticipate that ABT+TSCS will result in superior improvements in motor and autonomic functions in individuals with SCI.
Eligibility
Inclusion Criteria16
- 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
- Medication dosage must be stable for period of 4 weeks prior to participation
- Must provide informed consent
Exclusion Criteria15
- 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
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Interventions
Therapeutic TSCS will be delivered during ABT using a non-invasive central nervous system stimulator (TESCoN, SpineX Inc., CA, USA). Stimulation will involve charge balanced monophasic rectangular waveforms with 1.0-ms pulses, administered at 30 Hz, with a carrier frequency of 10 kHz and a current ranging from 10 to 130 mA.
Ineffective stimulation will be administered at the same anatomical location as therapeutic TSCS.
Using BWSTT, all participants (both arms) will train 3 times per week for 12 weeks with a target to reach 45 minutes of gait training in each session. For gait training, the level of body weight support and speed of walking will be adjusted to allow the person to bear as much weight as possible while maintaining proper stance limb kinematics.
Locations(1)
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NCT04726059