RecruitingNot ApplicableNCT03965299

Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury

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

Sponsor

University of Zurich

Enrollment

114 participants

Start Date

Jun 19, 2019

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury, Acute

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

Min Age: 18 Years

Inclusion Criteria8

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

Exclusion Criteria14

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
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)

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Interventions

DEVICEVERUM 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

DEVICESHAM 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