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临床试验/NCT03965299
NCT03965299招募中不适用

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

University of Zurich8 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2019年6月19日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
114
试验地点
8
主要终点
The occurrence of neurogenic DO jeopardizing the upper urinary tract
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The only unmasked person involved in the trial is the operator who will be responsible for the daily application of the study intervention at the patient. The role of an operator can be occupied by a research assistant/study nurse or investigator not involved in the clinical management and assessment of clinical outcomes. Thus, patients and care providers involved with clinical assessments are blinded.

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

结局指标

主要结局

The occurrence of neurogenic DO jeopardizing the upper urinary tract

时间窗: up to 12 months after SCI

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

次要结局

  • Changes in bladder compliance [mL/cmH2O] during urodynamics and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in bowel diary parameters and their relation to clinical outcomes(Baseline; once every 2 weeks during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in Qualiveen questionnaire scores and their relation to clinical outcomes(Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Volumetric changes during urodynamics and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in maximum flow rate [mL/s] as assessed by urodynamics and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in International Prostate Symptom (IPSS) questionnaire and their relation to clinical outcomes(Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in International Spinal Cord Society (ISCoS) Female / Male sexual function data sets and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in rectal compliance [mL/cmH2O] during anorectal manometry and barostat assessment and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in Female Sexual Function Index (FSFI) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in Neurogenic Bowel Dysfunction (NBD) score and their relation to clinical outcomes(Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in pelvic floor activity as assessed by electromyography (EMG) during urodynamics and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in International Index of Erectile Function (IIEF) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in Upper Extremities Motor Scale (UEMS) from International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in frequency power of surface electromyography (EMG) and electroencephalography (EEG) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Pressure changes during urodynamics and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in vesicoureterorenal reflux (VUR) as assessed by videography during urodynamics and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in bladder storage and voiding parameters and their relation to clinical outcomes(Baseline; once every 2 weeks during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in urinary symptoms as assessed by the Urinary Symptom Profile (USP) questionnaire and their relation to clinical outcomes(Baseline; once per week during the TTNS intervention period; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in Spinal Cord Independence Measure III (SCIM-III) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Volumetric changes during rectal sensitivity testing and barostat assessment and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Pressure changes during anorectal manometry and barostat assessment and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in EMG and EEG coherence measures and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in defecatory disorder [Rao's classification] identified during anorectal manometry and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in Lower Extremities Motor Scale (LEMS) from International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in spasticity in the knee and elbow flexors and extensors from the Modified Ashworth Scale (MAS) assessment and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in neurophysiology measurements of evoked potentials (EPs) as well as nerve conduction measurements and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in lower urinary tract (LUT) neurophysiology: Current perception thresholds (CPTs) and LUT sensory evoked potentials (LUTSEPs) with their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in white and gray matter area in the lumbosacral enlargement (LSE) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in white and gray matter area in upper cervical cord (at C2/C3) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • 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(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in white and gray matter volume of the conus medullaris (CM) and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in fractional anisotropy (FA) in the brain and spinal cord and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in brain and spinal cord tissue microstructure and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in inflammatory markers in bladder tissue, blood, and urine, as well as their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in gray and white matter volume in the brain and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in levels of neurotransmitters (neurotrophins) in blood, and urine, as well as their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in the composition of urinary and stool microbiome and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in diffusivity in the brain and spinal cord and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Expression profile of microRNA (miRNA) in urine and blood as well as their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)
  • Changes in bladder tissue and their relation to clinical outcomes(Baseline; 3 months after SCI; 6 months after SCI; 12 months after SCI / study end)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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