Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury

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.

Conditions

• Spinal Cord Injury, Acute

Interventions

DEVICE

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

DEVICE

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

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• Clinique Romande de Readaptation

  collaborator NETWORK

• Rehab Basel

  collaborator OTHER

• Swiss Paraplegic Research, Nottwil

  collaborator NETWORK

• BioMedical Research Forschungslabor für Urologie, University of Bern

  collaborator UNKNOWN

• Translational Neuro-Urology Department of Biomedicine, University of Porto

  collaborator UNKNOWN

• Center for Lower Urinary Tract Research School of Medicine, University of Pittsburgh

  collaborator UNKNOWN

• University of Zurich

  lead OTHER

Principal Investigators

• Thomas M. Kessler, Prof. Dr. med. · University of Zurich

• Thomas M. Kessler, Prof. Dr. med. · Balgrist University Hospital

• Armin Curt, Prof. Dr. med. · Balgrist University Hospital

• Martin Brinkhof, Dr. · Swiss Paraplegic Research, Nottwil

• Jürgen Pannek, Prof. Dr. med. · Swiss Paraplegic Centre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-19

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Switzerland

Study Locations