Noninvasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury

Launched by UNIVERSITY OF BRITISH COLUMBIA · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called transcutaneous spinal cord stimulation (TCSCS) to see if it helps improve certain bodily functions for people who have suffered a spinal cord injury (SCI). Specifically, the study aims to address issues related to autonomic dysfunction, which can affect things like bladder, bowel, and sexual functions. Researchers hope that by using this noninvasive technique, they can enhance the quality of life for individuals living with these challenges.

To participate in the trial, candidates must be between 18 and 60 years old, live in British Columbia, Canada, and have a specific type of spinal cord injury that causes complete loss of movement below the T6 level. They should also have experienced their injury for at least a year and have stable medical management for related issues. Participants will need to attend regular clinic visits and complete questionnaires throughout the study. It's important to note that certain health conditions or treatments may exclude someone from joining the trial, and women who can become pregnant must take precautions throughout the study. Overall, this trial offers a potential new approach to support recovery after spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • \>1-year post injury, at least 6 months from any spinal surgery.
• • American Spinal Injury Association Impairment Scale (AIS) A, B.
• • Stable management of spinal cord related clinical issues (i.e., spasticity management).
• • Documented impaired lower urinary tract, bowel or sexual function.
• • No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
• * For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
• • 1. 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. Use adequate contraception, or practice complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
• • 3. If using combined hormonal contraceptives, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.
• • For sexually active males with female partners of childbearing potential, use adequate contraception, or practice complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
• • Must provide informed consent.
• • 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).
• Exclusion Criteria:
• • Ventilator dependent.
• • Signs of lower motor neuron damage (i.e. concomitant conus medullaris/cauda equina injury).
• • Severe anemia (Hgb\<8 g/dl) or hypovolemia as measured by hematocrit via blood test in the last six months.
• • History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
• • History of seizures/epilepsy or recurring headaches.
• • History of gastrointestinal atresia or stenosis.
• • Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
• • Intrathecal baclofen pump.
• • Oral baclofen dose \> 60mg.
• • Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline.
• • Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
• • Past electrode implantation surgery.
• • Member of the investigational team or his/her immediate family.
• • Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study.