Motor & Autonomic Concomitant Health Improvements With Neuromodulation & Exercise Training: An SCI RCT

Launched by UNIVERSITY OF BRITISH COLUMBIA · Jan 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with spinal cord injuries (SCI) improve their movement and control of bodily functions, such as bladder and bowel control. The researchers will test a combination of two treatments: activity-based therapy (which involves exercises using a special treadmill that supports the body’s weight) and a non-invasive method called transcutaneous spinal cord stimulation, which aims to enhance the signals from the brain that help with movement. By comparing this combination treatment to a standard exercise program, the trial hopes to find out if the added stimulation provides greater benefits.

To be eligible for this study, participants should be between 18 to 60 years old, have a chronic spinal cord injury with complete paralysis, and be able to tolerate standing for 30 minutes. They must also be living in British Columbia, Canada, and willing to follow the study’s procedures. Participants can expect to attend three sessions a week for twelve weeks, where they will engage in the training and undergo assessments before and after the program. It’s important to note that women who could become pregnant will need to take precautions, and certain medical conditions or medications may disqualify individuals from joining. Overall, this trial represents a collaborative effort to improve the quality of life for those living with spinal cord injuries.

Gender

ALL

Eligibility 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