Spinal Cord InjuryNCT07429305
Combined Tibial Nerve Stimulation and Standing for People With SCI
A study testing Standing + Tibial Nerve Stimulation in people with Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Standing + Tibial Nerve Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
ICORD
Vancouver, British Columbia, V5Z 1M0
Yao Sun, PhD, 604-675-8815, lamlab@icord.org
About this study
Official title: Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy
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:
- What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI?
- What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI?
- 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
- Being tested
- Standing + Tibial Nerve Stimulation
- Keywords
- Spinal Cord Injury, Nerve Stimulation, Standing, Pelvic Floor
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing + Tibial Nerve StimulationBehavioural
Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standing + Tibial Nerve Stimulation | Experimental | Not described Receives: Behavioral: Standing + Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Reflex Excitability
We will electrically stimulate the tibial nerve and record reflexes responses from the pelvic floor muscles using perianal surface electromyography. We will examine the amplitude of the reflex response.
Measured: At baseline to within 2 weeks of completing the study intervention
Secondary outcomes (6)
Feasibility - Recruitment Rate
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Measured: Through study completion, an average of 8 months
Feasibility - Adherence
Adherence will be tracked by the compliance of participants to the intervention, with reasons for missed sessions or drop-outs noted.
Measured: Through study completion, an average of 8 months
Feasibility - Adverse Events
Any adverse events to study protocols will be recorded.
Measured: Through study completion, an average of 8 months
Acceptability
The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' opinions about the intervention (enjoyment and perceived benefits) and the outcome measures (tolerability and appropriateness of the measurement procedures). A higher score indicates a more acceptable intervention.
Measured: Through study completion, an average of 3 months
Neurogenic Bladder Symptoms Score (NBSS)
Participants will be asked to respond to 24 questions regarding the severity of their bladder symptoms secondary to neurological injury. Questions cover three subdomains: incontinence, storage and voiding, and consequences. The total score on this questionnaire ranges from 0-74, where a lower score represents less severe symptoms.
Measured: Through study completion, an average of 8 months
Incontinence Quality of Life Questionnaire (I-QoL)
Participants will be asked to respond to 22 questions about how urinary incontinence impacts their quality of life using a 5-point scale with values ranging from 1 (extremely) to 5 (not at all). The questionnaire probes three subdomains of how incontinence may affect quality of life: avoidance and limiting behavior, psychosocial impact, and social embarrassment. Total score on this questionnaire ranges from 0-100, where a higher score represents higher quality of life.
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start2 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Tania Lam, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429305
- Sponsor's protocol ID
- H25-01193
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy
- ClinicalTrials.gov ID
- NCT07429305
- Acronym / sponsor ID
- H25-01193
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Nerve Stimulation, Standing, Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI?
- What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standing + Tibial Nerve Stimulation | Experimental | Behavioral: Standing + Tibial Nerve Stimulation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standing + Tibial Nerve StimulationStanding (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks. | Behavioural | Standing + Tibial Nerve Stimulation |
Primary outcome
Pelvic Floor Muscle Reflex Excitability
Time frame: At baseline to within 2 weeks of completing the study intervention
We will electrically stimulate the tibial nerve and record reflexes responses from the pelvic floor muscles using perianal surface electromyography. We will examine the amplitude of the reflex response.
6 secondary outcomes
Feasibility - Recruitment Rate
Time frame: Through study completion, an average of 8 months
Feasibility - Adherence
Time frame: Through study completion, an average of 8 months
Feasibility - Adverse Events
Time frame: Through study completion, an average of 8 months
Acceptability
Time frame: Through study completion, an average of 3 months
Neurogenic Bladder Symptoms Score (NBSS)
Time frame: Through study completion, an average of 8 months
Incontinence Quality of Life Questionnaire (I-QoL)
Time frame: Through study completion, an average of 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing + Tibial Nerve Stimulation in people with Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Sun, PhD (604-675-8815, lamlab@icord.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscle Reflex Excitability (time frame: At baseline to within 2 weeks of completing the study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.