AzTrials
AzTrials

Spinal Cord Injury, AcuteTASCINCT03965299

Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury

A study testing VERUM TTNS in people with Spinal Cord Injury, Acute, run by University of Zurich at 4 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury, Acute
What is being tested?
VERUM TTNS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
4 sitesSwitzerland
Study dates
19 Jun 2019to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • Contraindications to the investigational product
  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas M. Kessler, Prof. Dr. med. contact

+41 44 386 39 07

thomas.kessler@balgrist.ch

Martina D. Liechti, Dr. sc. ETH contact

+41 44 386 39 07

martina.liechti@balgrist.ch

Switzerland4 sites, 4 recruiting

  • REHAB Basel

    Basel

    Sandra Möhr, pract. med., s.moehr@rehab.ch

    Sandra Möhr, pract. med.

    Recruiting

  • Swiss Paraplegic Centre

    Nottwil

    Jürgen Pannek, Prof. Dr. med., juergen.pannek@paraplegie.ch

    Jürgen Pannek, Prof. Dr. med.

    Recruiting

  • Spinal Cord Injury Department, Clinique romande de réadaption

    Sion

    Xavier Jordan, Dr. med., xavier.jordan@crr-suva.ch

    Xavier Jordan, Dr. med.

    Recruiting

  • Department of Neuro-Urology, Spinal Cord Injury Centre & Research, Balgrist University Hospital

    Zurich, Canton of Zurich, 8008

    Thomas M Kessler, Prof. Dr. med., +41 44 386 39 07, thomas.kessler@balgrist.ch

    Thomas M Kessler, Prof. Dr. med.

    Recruiting

Other trials in Switzerland

About this study

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

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.

Being tested
VERUM TTNS, SHAM TTNS
Keywords
randomized, sham-controlled, double-blind trial, transcutaneous tibial nerve stimulation, spinal cord injury, neurogenic detrusor overactivity, neuromodulation, electrical stimulation, paraplegia; tetraplegia, urodynamics
Medical subject headings
Spinal Cord Injuries, Paraplegia, Quadriplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VERUM TTNSDevice

    • 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 TTNSDevice

    • 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
Study groups in NCT03965299
Study groupRoleWhat they receive
VERUM transcutaneous tibial nerve stimulation (TTNS)ExperimentalNot described
Receives: Device: VERUM TTNS
SHAM transcutaneous tibial nerve stimulation (TTNS)Sham comparatorNot described
Receives: Device: SHAM TTNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of neurogenic DO jeopardizing the upper urinary tract

    Defined as composite measure: Urodynamic assessment establishing DO amplitude ≥40 cmH2O; or else initiation of DO treatment (with antimuscarinics and/or intradetrusor onabotulinumtoxinA injections)

    Measured: up to 12 months after SCI

Secondary outcomes (41)

  1. Volumetric changes during urodynamics and their relation to clinical outcomes

    Cystometric capacity [mL], volume at first DO [mL], voided volume [mL] and post void residual [mL] as assessed by urodynamic measurement

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  2. Changes in bladder compliance [mL/cmH2O] during urodynamics and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  3. Pressure changes during urodynamics and their relation to clinical outcomes

    Maximum DO amplitude [cmH2O], detrusor leak-point pressure [cmH2O], maximum detrusor pressure [cmH2O] during storage phase, maximum detrusor pressure [cmH2O] during voiding phase, detrusor pressure at maximum flow rate [cmH2O] as assessed by urodynamic measurement

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  4. Changes in maximum flow rate [mL/s] as assessed by urodynamics and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  5. Changes in vesicoureterorenal reflux (VUR) as assessed by videography during urodynamics and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  6. Changes in pelvic floor activity as assessed by electromyography (EMG) during urodynamics and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  7. Changes in bladder storage and voiding parameters and their relation to clinical outcomes

    Assessed by a bladder diary

    Measured: Baseline; once every 2 weeks during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  8. Changes in bowel diary parameters and their relation to clinical outcomes

    Assessed by a bowel diary

    Measured: Baseline; once every 2 weeks during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  9. Changes in International Prostate Symptom (IPSS) questionnaire and their relation to clinical outcomes

    The IPSS ("International Prostate Symptom Questionnaire") score is based on questions concerning urinary symptoms and quality of life (QoL). It consists of 8 items covering 7 urinary symptoms related dimensions (subscales) and 1 additional item assessing quality of life. Each item is rated on a 6-point scale (0=not at all; 5=almost always). The lowest possible score in the total IPSS score is 0 (asymptomatic); the highest possible score is 35 (symptomatic). The QoL index is rated on a 7-point scale, with 0 indicating "delighted" and 6 "terrible."

    Measured: Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  10. Changes in urinary symptoms as assessed by the Urinary Symptom Profile (USP) questionnaire and their relation to clinical outcomes

    The USP ("Urinary Symptom Profile") score is based on questions concerning urinary symptoms and their severity in males and females. It consists of 13 items covering 3 dimensions (subscales) with 7 overactive bladder (OAB), 3 stress urinary incontinence (SUI), and 3 low stream (LS) related items. Each item is rated on a 4-point scale. The lowest score is 0 (asymptomatic); the highest score is 3 (symptomatic).

    Measured: Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  11. Changes in Qualiveen questionnaire scores and their relation to clinical outcomes

    Qualiveen-30 assesses the Specific Impact of Urinary Problems (SIUP) on Quality of Life. It consists of 30 items covering 4 domains, namely inconvenience (9 questions), restrictions (8 questions), fears (8 questions), and impact on daily life (5 questions). Each item is rated on a 5-point ordinal scale (0=asymptomatic; 4=symptomatic). The index of the SIUP on Quality of Life is the mean of the four individual scores. The lowest possible overall score in the Qualiveen-30 is 0 (Urinary problems have no specific impact on QoL); the highest possible score is 30 (Urinary problems have a huge specific impact on QoL).

    Measured: Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  12. Changes in Female Sexual Function Index (FSFI) and their relation to clinical outcomes

    The FSFI ("Female Sexual Function Index") is based on questions concerning female sexual functions. It consists of 19 items covering 6 domains, namely sexual desire, arousal (both subjective and physiologic), lubrication, orgasm, satisfaction, and pain. The lowest possible score in the total FSFI is 2 (asymptomatic); the highest possible score is 36 (symptomatic).

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  13. Changes in International Index of Erectile Function (IIEF) and their relation to clinical outcomes

    The IIEF ("International Index of Erectile Function") is based on questions concerning erectile dysfunction. It consists of 15 items covering 5 domains, namely erectile functioning, orgasmic functioning, sexual desire, and intercourse satisfaction along with a fifth component which encompasses the concept of overall sexual satisfaction. While items 1-10 are rated on a 6-point Likert-type scale from 0 to 5, items 11-15 are rated on a 5-point Likert-type scale from 1 to 5. Higher scores are reflecting less dysfunction. Domain scores are computed by summing the sores for individual items in each domain.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  14. Changes in International Spinal Cord Society (ISCoS) Female / Male sexual function data sets and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  15. Changes in Neurogenic Bowel Dysfunction (NBD) score and their relation to clinical outcomes

    The NBD ("Neurogenic Bowel Dysfunction") score is based on questions concerning constipation and fecal incontinence and was developed for and validated in the spinal cord injury population. It consists of 10 items. The lowest possible score in the total NBD is 0 (asymptomatic); the highest possible score is 47 (symptomatic). The interpretation of the total NBD score is very minor NBD (0-6), minor NBD (7-9), moderate NBD (10-13), and severe NBD (≥14).The NBD score is assessed by using the international spinal cord injury (ISCoS) bowel function basic data set.

    Measured: Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  16. Volumetric changes during rectal sensitivity testing and barostat assessment and their relation to clinical outcomes

    Initial sensation [mL], volume at urge to defecate [mL], maximum tolerated volume [mL] as assessed by rectal sensitivity testing; rectal capacity [mL] assessed by barostat assessment

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  17. Pressure changes during anorectal manometry and barostat assessment and their relation to clinical outcomes

    Basal internal anal sphincter pressure [mmHg], squeeze external anal sphincter pressure [mmHg], relaxation internal anal sphincter pressure during defecation [%, mmHg], intraabdominal pressure during defecation [mmHg]

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  18. Changes in rectal compliance [mL/cmH2O] during anorectal manometry and barostat assessment and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  19. Changes in defecatory disorder [Rao's classification] identified during anorectal manometry and their relation to clinical outcomes

    Anorectal manometry is the preferable test for defecatory disorder. Rao's classification describes the four types of manometric patterns (I-IV) that are identified through manometric assessments

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  20. Changes International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol

    International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) assessment to quantify the severity of the spinal cord injury

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  21. Changes in Lower Extremities Motor Scale (LEMS) from International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol

    LEMS is based on assessments of ISNCSCI and composed from the sum of muscle function grading of the five key muscles of the lower limbs. It consists of a 6-point scale (0=no; 5=normal activity) for each muscle and body site. The lowest possible score in the total LEMS score for one body site is 0 (symptomatic); the highest possible score is 50 (asymptomatic).

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  22. Changes in Upper Extremities Motor Scale (UEMS) from International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol

    UEMS is based on assessments of ISNCSCI and composed from the sum of muscle function grading of the five key muscles of the upper limbs. It consists of a 6-point scale (0=no; 5=normal activity) for each muscle and body site. The lowest possible score in the total LEMS score for one body site is 0 (symptomatic); the highest possible score is 50 (asymptomatic).

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  23. Changes in Spinal Cord Independence Measure III (SCIM-III) and their relation to clinical outcomes

    The SCIM-III ("Spinal Cord Independence Measure III") score is based on questions concerning independence of persons with a spinal cord injured. It consists of 19 items covering 3 domains, self-care, respiration and sphincter management, and mobility. The self-care subscale ranges from 0 to 20. The respiration and sphincter management subscale ranges from 0 to 40. The mobility subscale ranges from 0 to 40. Total score ranges from 0 (symptomatic) to 100 (asymptomatic). Higher scores reflect higher levels of independence.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  24. Changes in spasticity in the knee and elbow flexors and extensors from the Modified Ashworth Scale (MAS) assessment and their relation to clinical outcomes

    The MAS is a 5-point nominal scale that uses subjective clinical assessments of muscle tone ranging from 0 - 'No increases in tone' to 4 - 'Limb rigid in flexion or extension'. A grade of (1+) indicates resistance in the movement.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  25. Changes in spasticity in daily life as assessed by the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) questionnaire and their relation to clinical outcomes

    The SCI-SET ("Spinal Cord Injury Spasticity Evaluation Tool ") score is based on questions concerning the positive and negative effects of spasticity on different areas of daily life. Each of the 35 items are rated on a 7-point scale (-3=extremely problematic; 0=no effect; 3=extremely helpful). Calculations include counts and sum scores of areas of daily life where spasticity is problematic (count range: 0 to 35, sum score range: 35 to 0) or helpful (counts range: 0 to 35, sum score range: 0 to +35) as well as a mean score of all applicable items (range: -3 to +3)

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  26. Changes in neurophysiology measurements of evoked potentials (EPs) as well as nerve conduction measurements and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  27. Changes in lower urinary tract (LUT) neurophysiology: Current perception thresholds (CPTs) and LUT sensory evoked potentials (LUTSEPs) with their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  28. Changes in frequency power of surface electromyography (EMG) and electroencephalography (EEG) and their relation to clinical outcomes

    Fast Fourier Transformation analysis for delta, theta, alpha, beta, and gamma band power as assessed via EEG of the cortex and EMG of the muscle

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  29. Changes in EMG and EEG coherence measures and their relation to clinical outcomes

    Coherence for EEG and EMG signals computed as cortico-muscular, inter- and intra-muscular coherence for typical EEG/EMG frequency bands (delta, theta, alpha, beta, and gamma).

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  30. Changes in white and gray matter area in the lumbosacral enlargement (LSE) and their relation to clinical outcomes

    White and gray matter areas are obtained by segmenting the T2*-weighted MRI images for white and gray matter at the level of LSE

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  31. Changes in white and gray matter area in upper cervical cord (at C2/C3) and their relation to clinical outcomes

    Obtained by segmenting the T2*-weighted MRI images for white and gray matter at the vertebral level C2/C3.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  32. Changes in white and gray matter volume of the conus medullaris (CM) and their relation to clinical outcomes

    White and gray matter volume are obtained by segmenting the T2*-weighted MRI images for white and gray matter in the CM

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  33. Changes in gray and white matter volume in the brain and their relation to clinical outcomes

    Gray and white matter volume in the brain are computed by feeding the whole-brain T1-weighted MRI images into a voxel-based morphometry algorithm. Changes in the gray and white matter volume will be evaluated in urologically relevant brain areas.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  34. Changes in fractional anisotropy (FA) in the brain and spinal cord and their relation to clinical outcomes

    FA is a common dimensionless measure used in Diffusion Tensor Imaging (DTI) studies and ranges from 0, isotropic movement of water molecules (e.g., cerebrospinal fluid), to 1, fully anisotropic movement of water molecules (e.g., fiber bundles).

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  35. Changes in diffusivity in the brain and spinal cord and their relation to clinical outcomes

    Mean, axial, and radial diffusivity (MD, AD, RD) are common measures used in DTI studies providing information about the integrity of the underlying tissue.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  36. Changes in brain and spinal cord tissue microstructure and their relation to clinical outcomes

    Quantitative tissue parameters assessed using MRI Multi-Parameter Mapping.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  37. Expression profile of microRNA (miRNA) in urine and blood as well as their relation to clinical outcomes

    MicroRNA (miRNA) sequencing is used to identify regulated miRNAs specific to TTNS intervention in urine and blood.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  38. Changes in inflammatory markers in bladder tissue, blood, and urine, as well as their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  39. Changes in levels of neurotransmitters (neurotrophins) in blood, and urine, as well as their relation to clinical outcomes

    Analysis will be performed using ELISA to detect molecules likely to be involved in the underlying molecular mechanisms of neuromodulation.

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  40. Changes in the composition of urinary and stool microbiome and their relation to clinical outcomes

    Gut and bladder microbial patterns are determined from stool and urine samples

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

  41. Changes in bladder tissue and their relation to clinical outcomes

    Measured: Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start19 Jun 2019
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03965299
Sponsor's protocol ID
2019-00074
Other IDs
2019
Acronym
TASCI
Status last verified
Nov 2026
First submitted
26 Mar 2019
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) and data dictionaries that underlie results in a publication are to be uploaded to a public data registry in cases where this can be done without compromising patient privacy. Given the small size of the dataset and that spinal cord injury (SCI) is a rare condition, to ensure identity protection any publicly available dataset(s) will be modified to reduce the number of indirect identifier variables, e.g. continuous variables such as age will be grouped, categorical or binary variables with small group numbers such as study centre will not be provided. When data sets cannot be sufficiently de-identified to be made publicly available, they will be made available upon reasonable request. Data judged to be confidential to participants or the participating study centers will not be released, but efforts will be made to provide scientifically meaningful equivalent information.

Publications

  • 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.

    PubMed 32792454

  • 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.

    PubMed 31601539

  • 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.

    PubMed 33235299

  • 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.

    PubMed 36192560

  • 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.

    PubMed 38626171

  • 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.

    PubMed 37509569

  • 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.

    PubMed 40034000

  • 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.

    PubMed 39869509

Questions about this trial

What is this clinical trial studying?

A study testing VERUM TTNS in people with Spinal Cord Injury, Acute, run by University of Zurich at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas M. Kessler, Prof. Dr. med. (+41 44 386 39 07, thomas.kessler@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of neurogenic DO jeopardizing the upper urinary tract (time frame: up to 12 months after SCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03965299, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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