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Recruiting NCT05681936

Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury

Conditions: Spinal Cord Injuries, Neurogenic Bladder Dysfunction, Degenerative Cervical Spinal Stenosis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 225
Sponsor: University of Zurich

Location: Switzerland

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 yearsInformed consentWilling to take part and follow requirements of the protocolPatients additionally need to fulfil the following study-specific inclusion criteria:Cross-sectional study:Chronic traumatic SCI (> 12 months after injury) orDiagnosed degenerative spondylotic myelopathy (DCM)Longitudinal study:Acute traumatic SCI (< 2 months after injury) orPatients 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 HospitalExclusion Criteria:Age < 18 yearsContraindications 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 studyNo informed consentHistory of psychiatric or neurological disease, apart from those induced by SCI (e.g.epilepsy)History of skull opening or head traumaKnown or suspected non-adherence, drug or alcohol abuseInability 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 breastfeedingIntention to become pregnant during the course of the studyBody mass index (BMI) > 35Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)

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Source: ClinicalTrials.gov (NCT05681936). StuddyBuddy aggregates publicly available trial information.