Actively Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Led by University of Zurich · Updated on 2026-01-20
114
Participants Needed
4
Research Sites
380 weeks
Total Duration
On this page
Sponsors
U
University of Zurich
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Most patients with spinal cord injury (SCI) develop neurogenic lower urinary tract dysfunction (NLUTD), one of the most devastating sequelae of SCI which ultimately can lead to renal failure. We urgently need an intervention that prevents NLUTD before irreversible damage occurs. Neuromodulation procedures are a promising avenue so that we investigate the effect of transcutaneous tibial nerve stimulation (TTNS) in patients with acute SCI. This nationwide randomized, sham-controlled, double-blind multicentre clinical trial includes all SCI centres in Switzerland (Basel, Nottwil, Sion, Zürich). Patients are randomly assigned to VERUM TTNS (active stimulation, n=57) and SHAM stimulation (n=57) groups in a 1:1 allocation using computer-generated permuted block randomisation lists stratified on study centre and lower extremity motor score. Daily 30-minute sessions are performed five times a week during an intervention period of 6-9 weeks. The primary outcome of this study is the success of TTNS to prevent neurogenic DO jeopardizing the upper urinary tract, assessed by urodynamics at 1 year after SCI or any earlier time point if DO treatment is necessary (study end). Secondary outcome measures are bladder diary parameters, clinical symptom scores assessed by standardized and validated questionnaires. Furthermore, neurophysiological and neuroimaging outcome measures are assessed as well as, biochemical and molecular changes. Tertiary outcome measure is the safety of TTNS. Before the actual start of the TASCI RCT, start-up activities will include a piloting phase on groups of healthy volunteers and patients. The goal during this phase is to evaluate the feasibility of the experimental setup, in particular for the TTNS and SHAM intervention, but also to test the setup of the different pre and post assessments (e.g. neurophysiology and neuroimaging tests). Groups of up to 15 participants each will be enrolled in a few consecutive pilot studies allowing for fine tuning and small adaptations in between, if appropriate.
CONDITIONS
Official Title
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Patients with acute spinal cord injury (SCI), traumatic or sudden non-traumatic, within 40 days after injury
- SCI located at cervical or thoracic level
- Willing to participate and follow the study protocol for up to one year
- No prior use of percutaneous tibial nerve stimulation (PTNS)
- No functional electrical stimulation (FES) except for upper limb FES
- No electrical muscle stimulation (EMS)
- Signed informed consent
You will not qualify if you...
- Contraindications to the investigational product
- Presence of detrusor overactivity with contractions over 40 cmH2O at bladder filling below 500 mL at baseline
- Current treatment with antimuscarinics or mirabegron
- Known or suspected non-adherence, drug or alcohol abuse
- Unable to follow study procedures due to language, psychological disorders, dementia, or similar
- Participation in another investigational drug or product study within 30 days before or during this study
- Neuromodulation treatment for urinary or bowel issues within last 6 months or ongoing
- Botulinum toxin injections in bladder or urethral sphincter within last 6 months
- Bilaterally absent tibial nerve muscle action potential (amplitude under 1 mV)
- Pregnant or breastfeeding women
- Intention to become pregnant during the study
- Individuals needing special protection as defined by Swiss Academy of Medical Sciences
- Investigator, family, employees, or dependents enrolled
- Other medical conditions besides SCI that may risk safety or affect study results (e.g., Parkinson's, multiple sclerosis, ALS, urological cancers)
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Trial Site Locations
Total: 4 locations
1
Department of Neuro-Urology, Spinal Cord Injury Centre & Research, Balgrist University Hospital
Zurich, Canton of Zurich, Switzerland, 8008
Actively Recruiting
2
REHAB Basel
Basel, Switzerland
Actively Recruiting
3
Swiss Paraplegic Centre
Nottwil, Switzerland
Actively Recruiting
4
Spinal Cord Injury Department, Clinique romande de réadaption
Sion, Switzerland
Actively Recruiting
Research Team
T
Thomas M. Kessler, Prof. Dr. med.
CONTACT
M
Martina D. Liechti, Dr. sc. ETH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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