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New treatment option for Spinal Cord Injury, Acute
Official title Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
ClinicalTrials.gov ID: NCT03965299
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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 people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
- Basel, Switzerland
- Nottwil, Switzerland
- Sion, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland; Basel, Switzerland; Nottwil, Switzerland; Sion, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.