Standing + Tibial Nerve Stimulation for Spinal Cord Injury

Overseen By Yao Sun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Botulinum toxin-A

Disqualifiers: Non-stable SCI, Other neurological injury, Implanted device, Severe acute medical issue, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to understand how sensory inputs from the lower leg can influence pelvic floor muscle function and urogential function in adults with chronic spinal cord injury (SCI). The main questions it aims to answer are:

1. What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI?

2. What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI?

3. What are the potential effects of combined tibial neuromodulation and standing therapy on reflex excitability and urogential symptoms and quality of life in people with SCI?

Participants will be asked complete a series of assessments (questionnaires, electrophysiological testing) before and after a 12-week intervention of combined standing and tibial nerve stimulation therapy.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am at least 19 years old.

I meet the safety requirements to use a standing frame.

I have a spinal cord injury that affects my movement.

Exclusion Criteria

I have had or plan to have a Botulinum toxin-A injection in my urinary tract recently.

Have an implanted metallic or electronic device (e.g. pacemaker, nerve stimulator)

I have a spinal cord injury or tumor that is not stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week intervention of combined standing and tibial nerve stimulation therapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pelvic floor muscle reflex excitability and quality of life

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standing + Tibial Nerve Stimulation

How Is the Trial Designed?

Group I: Standing + Tibial Nerve Stimulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+