Combined Tibial Nerve Stimulation and Standing for People With SCI

Official title

Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy

Overview

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.

Interventions

• Behavioral 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 measures

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

Secondary outcome measures (6)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• ICORD — Vancouver

Identifiers

NCT: NCT07429305 · H25-01193

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗