Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich
About this trial
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
This trial accepts healthy volunteersQualifiers
Age > 18 years
Informed consent
Willing to take part and follow requirements of the protocol
Chronic traumatic SCI (> 12 months after injury) or
Disqualifiers
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)
Trial population
The participants will be recruited from the primary care clinic as well as via flyers distributed at hospital waiting rooms and patient support organisations. Healthy controls will be recruited via public announcements and via flyers distributed at the primary care clinic and two universities.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
225 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Cross-sectional study: healthy controls
Group B: Cross-sectional study: chronic traumatic SCI patients
Group C: Cross-sectional study: non-traumatic SCI patients with degenerative spondylotic myelopathy
Group D: Longitudinal study: healthy controls
Group E: Longitudinal study: acute traumatic SCI patients (< 2 months after SCI)
Group F: Longitudinal study: patients with neurogenic lower urinary tract dysfunction
Trial outcomes
Primary outcomes
1
Cross-sectional study: lumbosacral functional fMRI
Activations in the gray matter of the lumbosacral cord, as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state). Spatiotemporal components of the BOLD signal as well as the couplings and anti-couplings between these components
Time frame
Baseline only2
Longitudinal study: lumbosacral functional fMRI
Activations in the gray matter of the lumbosacral cord, as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state). Spatiotemporal components of the BOLD signal as well as the couplings and anti-couplings between these component
Time frame
Change from baseline at 2-month, 6-month, and 12-month3
Cross-sectional study: brain functional MRI
Activations in the cortical and subcortical areas of the brain as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state)
Time frame
Baseline only4
Longitudinal study: brain functional MRI
Activations in the cortical and subcortical areas of the brain as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state)
Time frame
Change from baseline at 2-month, 6-month, and 12-monthSecondary outcomes
1
Cross-sectional study: diffusion MRI in the spinal cord
Directional diffusivities in the spinal cord (units of mm2/s)
Time frame
Baseline only2
Cross-sectional study: diffusion MRI in the spinal cord
Fractional anisotropy in the spinal cord (unitless)
Time frame
Baseline only3
Longitudinal study: diffusion MRI in the spinal cord
Directional diffusivities in the spinal cord, measured (units of mm2/s)
Time frame
Change from baseline at 2-month, 6-month, and 12-month4
Longitudinal study: diffusion MRI in the spinal cord
Fractional anisotropy in the spinal cord (unitless)
Time frame
Change from baseline at 2-month, 6-month, and 12-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Zurich
Lead sponsor
Swiss National Science Foundation
Collaborator
Swiss Paraplegic Research, Nottwil
Collaborator
Source ClinicalTrials.gov