Recruiting

Tibial Neuromodulation & Standing Therapy

Sponsor:

University of British Columbia

Code:

NCT07429305

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Standing + Tibial Nerve Stimulation

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injury

Study ID

NCT07429305

Start date

Apr 2, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 19 years of age
  • Have a SCI between C7 - T10 that occurred at least 12 months previously
  • Have a motor-complete or incomplete SCI (AIS A, B, C, or D)
  • Have symptoms of neurogenic LUT dysfunction
  • Meet the manufacture requirements for standing frame use (will be evaluated by the research team)
  • Are able to speak and understand English.

Exclusion Criteria:

  • Have changed their bladder management program in the past month
  • Have received an injection of Botulinum toxin-A in any LUT structure in the past 2 weeks, or intend to receive an injection while participating in the trial
  • Have a non-stable SCI (e.g. spinal tumor)
  • Have signs of a lower motoneuron injury (e.g. cauda equina syndrome)
  • Have other neurological injury besides SCI
  • Have an implanted metallic or electronic device (e.g. pace maker, nerve stimulator)
  • Have a condition for which exercise or transcutaneous stimulation is contraindicated
  • Have a 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 acute urinary tract infections, pressure sores, musculoskeletal injury, or unmanage blood pressure.
  • Are currently pregnant or have given birth within the past 12 months
  • Use walking as your primary means of movement around your home and the community.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standing + Tibial Nerve Stimulation

Interventions

Standing + Tibial Nerve Stimulation

Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks.

Primary outcome measure

  • Pelvic Floor Muscle Reflex Excitability [ Time Frame: At baseline to within 2 weeks of completing the study intervention ]

Central Contacts and Locations

Central contacts

Yao Sun, PhD

604-675-8815lamlab@icord.org

Locations

ICORD

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M0

Contacts

Yao Sun, PhD

604-675-8815lamlab@icord.org

More Information

Sponsor

University of British Columbia

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Spinal Cord Injury
  • Nerve Stimulation
  • Standing
  • Pelvic Floor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-04-08.