NCT07429305

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. 1.What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI?
  2. 2.What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI?
  3. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

February 11, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 11, 2026

Last Update Submit

April 2, 2026

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryNerve StimulationStandingPelvic Floor

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline to within 2 weeks of completing the study intervention

Secondary Outcomes (6)

  • Feasibility - Recruitment Rate

    Through study completion, an average of 8 months

  • Feasibility - Adherence

    Through study completion, an average of 8 months

  • Feasibility - Adverse Events

    Through study completion, an average of 8 months

  • Acceptability

    Through study completion, an average of 3 months

  • Neurogenic Bladder Symptoms Score (NBSS)

    Through study completion, an average of 8 months

  • +1 more secondary outcomes

Study Arms (1)

Standing + Tibial Nerve Stimulation

EXPERIMENTAL
Behavioral: Standing + Tibial Nerve Stimulation

Interventions

Standing + Tibial Nerve StimulationBEHAVIORAL

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

Standing + Tibial Nerve Stimulation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICORD

Vancouver, British Columbia, V5Z 1M0, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Standing Position

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yao Sun, PhD

CONTACT

604-675-8815lamlab@icord.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 24, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)