NCT05681936 Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
| NCT ID | NCT05681936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Spinal Cord Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2023-01-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Building on recent improvements, state-of-the-art functional MRI will be applied as an advanced diagnostic tool for the lumbosacral cord in spinal cord injury (SCI) patients to characterize the remaining neuronal activity of the motor and sensory neurons. Alterations in the activity pattern will reveal the effect upon task-related spinal cord activity of the lower motor neurons and sensory neurons undergoing trauma-induced neurodegeneration, at a spatial specificity that has not been possible so far. Results of this study will be of crucial importance because SCI patients can only profit from regeneration-inducing therapies if spinal neuronal function is preserved below the level of lesion.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years * Informed consent * Willing to take part and follow requirements of the protocol Patients additionally need to fulfil the following study-specific inclusion criteria: Cross-sectional study: * Chronic traumatic SCI (\> 12 months after injury) or * Diagnosed degenerative spondylotic myelopathy (DCM) Longitudinal study: * Acute traumatic SCI (\< 2 months after injury) or * Patients with neurogenic lower urinary tract dysfunction (NLUTD) who undergo routine tibial nerve stimulation (TNS) treatment as part of their rehabilitation (but independently of this study) at Balgrist University Hospital Exclusion Criteria: * Age \< 18 years * Contraindications for MRI (presence of pacemaker or other type of stimulator in the body, presence of metallic foreign body in or on the body, etc.); we will comply with the imaging center's (SCMI) guidelines and in case of doubt we will exclude the participant from the study * No informed consent * History of psychiatric or neurological disease, apart from those induced by SCI (e.g.epilepsy) * History of skull opening or head trauma * 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. * Women who are pregnant (when uncertain, participants will undergo urine testing) or breastfeeding * Intention to become pregnant during the course of the study * Body mass index (BMI) \> 35 * Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
Contact & Investigator
Patrick Freund, Prof. Dr. med. Dr. rer. nat.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT05681936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05681936 currently recruiting?
Yes, NCT05681936 is actively recruiting participants. Contact the research team at gergely.david@balgrist.ch for enrollment information.
Where is the NCT05681936 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT05681936 clinical trial?
NCT05681936 is sponsored by University of Zurich. The principal investigator is Patrick Freund, Prof. Dr. med. Dr. rer. nat. at University of Zurich. The trial plans to enroll 225 participants.