Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury
Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure. In this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with spinal cord injury (SCI). This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
• Resident of British Columbia, Canada with active provincial medical services plan
• Male or female, 18-65 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.
• Documented presence of bladder dysfunction (NDO during UDS)
• Documented presence of bowel or sexual dysfunction.
• American Spinal Injury Association Impairment Scale (AIS) A, B.
• Greater than or equal to antigravity strength in deltoids and biceps bilaterally
• Hand function sufficient to perform Clean Intermittent Catheterization (CIC) or a committed caregiver to provide CIC for management of urinary bladder drainage.
⁃ Participants must have documented three days of bladder and bowel history prior to their baseline visit.
⁃ 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\*\
‣ 2\
‣ \* 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.