Clinical trial NCT05681936: Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
Official title: Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Neurogenic Bladder Dysfunction
Degenerative Cervical Spinal Stenosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Swiss Paraplegic Research, Nottwil
First posted: 2023-01-12
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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)

Primary outcomes:
measure: Cross-sectional study: lumbosacral functional fMRI
timeFrame: Baseline only
measure: Longitudinal study: lumbosacral functional fMRI
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: brain functional MRI
timeFrame: Baseline only
measure: Longitudinal study: brain functional MRI
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
Secondary outcomes:
measure: Cross-sectional study: diffusion MRI in the spinal cord
timeFrame: Baseline only
measure: Cross-sectional study: diffusion MRI in the spinal cord
timeFrame: Baseline only
measure: Longitudinal study: diffusion MRI in the spinal cord
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: diffusion MRI in the spinal cord
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: structural MRI in spinal cord
timeFrame: Baseline only
measure: Longitudinal study: structural MRI in spinal cord
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus
timeFrame: Baseline only
measure: Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus
timeFrame: Baseline only
measure: Longitudinal study: magnetic resonance neurography of the lumbosacral plexus
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: magnetic resonance neurography of the lumbosacral plexus
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: diffusion MRI in the brain
timeFrame: Baseline only
measure: Cross-sectional study: diffusion MRI in the brain
timeFrame: Baseline only
measure: Longitudinal study: diffusion MRI in the brain
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: diffusion MRI in the brain
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: structural MRI in the brain
timeFrame: Baseline only
measure: Cross-sectional study: structural MRI in the brain
timeFrame: Baseline only
measure: Longitudinal study: structural MRI in the brain
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: structural MRI in the brain
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: nerve conduction study
timeFrame: Baseline only
measure: Cross-sectional study: nerve conduction study
timeFrame: Baseline only
measure: Cross-sectional study: nerve conduction study
timeFrame: Baseline only
measure: Longitudinal study: nerve conduction study
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: nerve conduction study
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: nerve conduction study
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: motor evoked potentials (MEP)
timeFrame: Baseline only
measure: Cross-sectional study: motor evoked potentials (MEP)
timeFrame: Baseline only
measure: Longitudinal study: motor evoked potentials (MEP)
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: motor evoked potentials (MEP)
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Baseline only
measure: Cross-sectional study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Baseline only
measure: Cross-sectional study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Baseline only
measure: Cross-sectional study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Baseline only
measure: Cross-sectional study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Baseline only
measure: Longitudinal study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
timeFrame: Baseline only
measure: Longitudinal study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: European Multicenter Study about SCI (EMSCI) pain questionnaire
timeFrame: Baseline only
measure: Longitudinal study: European Multicenter Study about SCI (EMSCI) pain questionnaire
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings
timeFrame: Baseline only
measure: Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings
timeFrame: Baseline only
measure: Longitudinal study: sympathetic skin response including hand, sole and perineum recordings
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: sympathetic skin response including hand, sole and perineum recordings
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: Spinal Cord Independence Measure (SCIM III)
timeFrame: Baseline only
measure: Longitudinal study: Spinal Cord Independence Measure (SCIM III)
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Cross-sectional study: Walking index for Spinal Cord Injury (WISCI)
timeFrame: Baseline only
measure: Longitudinal study: Walking index for Spinal Cord Injury (WISCI)
timeFrame: Change from baseline at 2-month, 6-month, and 12-month
measure: Longitudinal study: International Prostate Symptom Score (IPSS) (only in patients with neurogenic lower urinary tract dysfunction)
timeFrame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
measure: Longitudinal study: Qualiveen questionnaire (only in patients with neurogenic lower urinary tract dysfunction)
timeFrame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
measure: Longitudinal study: Urinary Symptom Profile (USP) (only in patients with neurogenic lower urinary tract dysfunction)
timeFrame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
measure: Longitudinal study: Overactive Bladder (ICIQ-OAB) questionnaire (only in patients with neurogenic lower urinary tract dysfunction)
timeFrame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: University of Zurich
name: Patrick Freund, Prof. Dr. med. Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
References: