Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Foll… (NCT04604951) | Clinical Trial Compass
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Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury
Canada40 participantsStarted 2022-05-02
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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 clinically significant renal or hepatic disease; acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications \[tricyclics\]; or unstable diabetes. The following conditions apply:
What they're measuring
1
Change in bladder capacity measured by urodynamics
Timeframe: Weeks 4-6, Week 19
2
Change in resting anorectal pressure determined via anorectal manometry
✕. Moderate and severe forms of renal dysfunctions (eGFR below 60 ml/min)
✕. Clinically significant abnormal laboratory tests (ALT; Alkaline Phosphatase; Bilirubin \[total\]; GGT) as judged by the investigator.
✕. Recent treatment with OnabotulinumtoxinA into the detrusor muscle (within 9 months of the baseline visit)
✕. Ventilator dependent
✕. Clinically significant depression 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.