Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Key facts
- Who runs it
- University of Zurich
- Where
- Basel, Nottwil, Sion, and Zurich, SwitzerlandSee the 4 sites
- Trial code
- Status
- Recruiting
- People taking part
- 114 people, planned
- Started
- 19 Jun 2019
- Expected to end
- 30 Sept 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- VERUM TTNS
- SHAM TTNS
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Age >18 years
- Patients with acute SCI (traumatic SCI and sudden onset (<7 days) non-traumatic SCI) within 40 days after injury
- Patients with acute SCI at cervical or thoracic level
- Willing to take part and follow the requirements of the TASCI protocol (up to one year after SCI); no percutaneous tibial nerve stimulation (PTNS); no functional electrical stimulation (FES), apart from upper limb FES; no electrical muscle stimulation (EMS)
- Informed Consent
Who cannot take part
- Contraindications to the investigational product
- Treatment with antimuscarinics or with mirabegron
- Known or suspected non-adherence, drug or alcohol abuse
- Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- Pre-existing or concomitant medical condition apart from SCI that might pose a safety issue or would interfere with interpretation of study results or study conduct (e.g. Parkinson's disease, neurodegenerative disorders including multiple sclerosis and amyotrophic lateral sclerosis, urological malignancies)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- DO with contractions greater than 40 cmH2O at a bladder filling volume of less than 500mL at baseline visit
- Neuromodulation treatment for urological or bowel indication in the last six months or ongoing
- Botulinum toxin injections in the detrusor and/or urethral sphincter in the last six months
- Bilaterally absent tibial nerve compound muscle action potential (cMAP, amplitude < 1mV)
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences [www.samw.ch/en/News/News.html])
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Where in Switzerland
- REHAB BaselBasel, SwitzerlandContact: Sandra Möhr, pract. med.Taking people
- Swiss Paraplegic CentreNottwil, SwitzerlandContact: Jürgen Pannek, Prof. Dr. med.Taking people
- Spinal Cord Injury Department, Clinique romande de réadaptionSion, SwitzerlandContact: Xavier Jordan, Dr. med.Taking people
- Department of Neuro-Urology, Spinal Cord Injury Centre & Research, Balgrist University HospitalZurich, SwitzerlandContact: Thomas M Kessler, Prof. Dr. med.Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- VERUM transcutaneous tibial nerve stimulation (TTNS)Treatment being tested
Treatment: VERUM TTNS
- SHAM transcutaneous tibial nerve stimulation (TTNS)Sham treatment, for comparison
Treatment: SHAM TTNS
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Transcutaneous Tibial Nerve Stimulation in Patients With Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity: A Nationwide Randomised, Sham-controlled, Double-blind Clinical Trial
- Record updated
- 5 November 2026