Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
NCT ID: NCT03965299
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
114 participants
INTERVENTIONAL
2019-06-19
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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VERUM transcutaneous tibial nerve stimulation (TTNS)
VERUM TTNS
* Daily 30-minute TTNS intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments
* During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase
SHAM transcutaneous tibial nerve stimulation (TTNS)
SHAM TTNS
* Daily 30-minute SHAM intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments
* During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase
Interventions
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VERUM TTNS
* Daily 30-minute TTNS intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments
* During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase
SHAM TTNS
* Daily 30-minute SHAM intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments
* During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* DO with contractions greater than 40 cmH2O at a bladder filling volume of less than 500mL at baseline visit
* Treatment with antimuscarinics or with mirabegron
* Known or suspected non-adherence, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug or product within the 30 days preceding and during the present study
* 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
* 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)
18 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Clinique Romande de Readaptation
NETWORK
Rehab Basel
OTHER
Swiss Paraplegic Research, Nottwil
NETWORK
BioMedical Research Forschungslabor für Urologie, University of Bern
UNKNOWN
Translational Neuro-Urology Department of Biomedicine, University of Porto
UNKNOWN
Center for Lower Urinary Tract Research School of Medicine, University of Pittsburgh
UNKNOWN
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Thomas M. Kessler, Prof. Dr. med.
Role: STUDY_CHAIR
University of Zurich
Thomas M. Kessler, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Balgrist University Hospital
Armin Curt, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Balgrist University Hospital
Martin Brinkhof, Dr.
Role: PRINCIPAL_INVESTIGATOR
Swiss Paraplegic Research, Nottwil
Jürgen Pannek, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Swiss Paraplegic Centre
Locations
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Department of Neuro-Urology, Spinal Cord Injury Centre & Research, Balgrist University Hospital
Zurich, Canton of Zurich, Switzerland
REHAB Basel
Basel, , Switzerland
Swiss Paraplegic Centre
Nottwil, , Switzerland
Spinal Cord Injury Department, Clinique romande de réadaption
Sion, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Birkhauser V, Liechti MD, Anderson CE, Bachmann LM, Baumann S, Baumberger M, Birder LA, Botter SM, Bueler S, Cruz CD, David G, Freund P, Friedl S, Gross O, Hund-Georgiadis M, Husmann K, Jordan X, Koschorke M, Leitner L, Luca E, Mehnert U, Mohr S, Mohammadzada F, Monastyrskaya K, Pfender N, Pohl D, Sadri H, Sartori AM, Schubert M, Sprengel K, Stalder SA, Stoyanov J, Stress C, Tatu A, Tawadros C, van der Lely S, Wollner J, Zubler V, Curt A, Pannek J, Brinkhof MWG, Kessler TM. TASCI-transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial. BMJ Open. 2020 Aug 13;10(8):e039164. doi: 10.1136/bmjopen-2020-039164.
Liechti MD, van der Lely S, Stalder SA, Anderson CE, Birkhauser V, Bachmann LM, Brinkhof MWG, Curt A, Jordan X, Leitner L, Mehnert U, Mohr S, Pannek J, Schubert M, Kessler TM; TASCI Study Group. Update from TASCI, a Nationwide, Randomized, Sham-controlled, Double-blind Clinical Trial on Transcutaneous Tibial Nerve Stimulation in Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity. Eur Urol Focus. 2020 Sep 15;6(5):877-879. doi: 10.1016/j.euf.2019.09.019. Epub 2019 Oct 8.
Anderson CE, Birkhauser V, Stalder SA, Bachmann LM, Curt A, Jordan X, Leitner L, Liechti MD, Mehnert U, Mohr S, Pannek J, Schubert M, van der Lely S, Kessler TM, Brinkhof MWG. Optimizing clinical trial design using prospective cohort study data: a case study in neuro-urology. Spinal Cord. 2021 Sep;59(9):1003-1012. doi: 10.1038/s41393-020-00588-z. Epub 2020 Nov 24.
Bueler S, Yiannakas MC, Damjanovski Z, Freund P, Liechti MD, David G. Optimized multi-echo gradient-echo magnetic resonance imaging for gray and white matter segmentation in the lumbosacral cord at 3 T. Sci Rep. 2022 Oct 3;12(1):16498. doi: 10.1038/s41598-022-20395-1.
Bueler S, Freund P, Kessler TM, Liechti MD, David G. Improved inter-subject alignment of the lumbosacral cord for group-level in vivo gray and white matter assessments: A scan-rescan MRI study at 3T. PLoS One. 2024 Apr 16;19(4):e0301449. doi: 10.1371/journal.pone.0301449. eCollection 2024.
Stalder SA, van der Lely S, Anderson CE, Birkhauser V, Curt A, Gross O, Leitner L, Mehnert U, Schubert M, Tornic J, Kessler TM, Liechti MD. Development of a Sham Protocol to Investigate Transcutaneous Tibial Nerve Stimulation in Randomised, Sham-Controlled, Double-Blind Clinical Trials. Biomedicines. 2023 Jul 7;11(7):1931. doi: 10.3390/biomedicines11071931.
Beghini L, Bueler S, Liechti MD, Jaffray A, David G, Vannesjo SJ. Optimized navigator-based correction of breathing-induced B0 field fluctuations in multi-echo gradient-echo imaging of the spinal cord. Magn Reson Med. 2025 Jul;94(1):215-230. doi: 10.1002/mrm.30475. Epub 2025 Mar 4.
Bueler S, Anderson CE, Birkhauser V, Freund P, Gross O, Kessler TM, Kundig CW, Leitner L, Mahnoor N, Mehnert U, Rothlisberger R, Stalder SA, van der Lely S, Zipser CM, David G, Liechti MD. Remote neurodegeneration in the lumbosacral cord one month after spinal cord injury: a cross-sectional MRI study. Ann Clin Transl Neurol. 2025 Mar;12(3):523-537. doi: 10.1002/acn3.52298. Epub 2025 Jan 27.
Related Links
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TASCI on Swiss National Science Foundation grant database
Other Identifiers
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2019-00074
Identifier Type: -
Identifier Source: org_study_id
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