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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
REHAB Basel
RECRUITING
Basel
Swiss Paraplegic Centre
RECRUITING
Nottwil
Spinal Cord Injury Department, Clinique romande de réadaption
RECRUITING
Sion
Department of Neuro-Urology, Spinal Cord Injury Centre & Research, Balgrist University Hospital
RECRUITING
Zurich
Contact Information
Primary
Thomas M. Kessler, Prof. Dr. med.
thomas.kessler@balgrist.ch
+41 44 386 39 07
Backup
Martina D. Liechti, Dr. sc. ETH
martina.liechti@balgrist.ch
+41 44 386 39 07
Time Frame
Start Date: 2019-06-19
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 114
Treatments
Experimental: VERUM transcutaneous tibial nerve stimulation (TTNS)
Sham_comparator: SHAM transcutaneous tibial nerve stimulation (TTNS)
Related Therapeutic Areas
Sponsors
Collaborators: Swiss Paraplegic Research, Nottwil, Swiss National Science Foundation, Clinique Romande de Readaptation, Translational Neuro-Urology Department of Biomedicine, University of Porto, BioMedical Research Forschungslabor für Urologie, University of Bern, Center for Lower Urinary Tract Research School of Medicine, University of Pittsburgh, Rehab Basel
Leads: University of Zurich

This content was sourced from clinicaltrials.gov