Noninvasive Spinal Cord Stimulation for Early SCI

Launched by UNIVERSITY OF BRITISH COLUMBIA · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a non-invasive treatment called transcutaneous spinal cord stimulation (TSCS) to help improve various functions in people who have had a spinal cord injury (SCI) for 3 to 6 months. The goal is to see if this treatment can help with issues such as bladder control, bowel function, sexual health, and overall quality of life. The study will take place in Canada and Ukraine, with up to 60 adults participating. Eligible participants are between 19 and 65 years old, have certain types of spinal cord injuries, and need to have specific problems with bladder function.

If you join the study, you will be assigned to one of two groups. One group will receive the TSCS treatment along with regular rehabilitation sessions for 8 weeks, while the other group will initially receive a placebo (sham stimulation) but will switch to the treatment later. Over the course of the study, you will attend a total of 58 visits for assessments, therapy, and follow-up, lasting about 33 weeks in total. It’s important to note that there are specific criteria for joining, including not having certain medical conditions or recent surgeries, so it's a good idea to talk to your doctor to see if this trial may be right for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * A participant must meet all of the following criteria in order to be eligible to participate:
• • 1. Age between 19 and 65 years at the time of consent
• • 2. Subacute SCI (time since injury 3-6months)
• • 3. ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
• • 4. Documented impaired LUT function
• 5. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
• • i. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
• • ii. 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.
• • 6. 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.
• • 7. Must provide informed consent.
• • 8. Agrees to comply with all planned visits and assessments, adhere with established bowel and LUT routines and refrain from initiation of new medications for bowel and LUT management without notifying the Principal Investigator of this study.
• Exclusion Criteria:
• * A participant who meets any of the following criteria will be ineligible to participate:
• • 1. Clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above) or as judged by the investigator
• • 2. History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
• • 3. Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
• • 4. History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.
• • 5. Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.
• • 6. Presence of cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation and completion of the study
• • 7. Presence of severe acute medical issues that interfere with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes).
• 8. Contraindications for TSCS, such as:
• • 8.1. Implanted Cardiac pacemaker 8.2 Implanted metal in the trunk or spinal cord 8.3 Intrathecal delivery system (e.g., baclofen pump) 8.4 Implanted central or peripheral neuromodulator
• • 9. Medical condition that may put the participant at risk as determined by the investigator.
• • 10. Participation in or plans to participate in another research study that may interfere with the study endpoints.