Spinal Cord InjuriesNCT05681936
Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
An observational study of Spinal Cord Injuries and Neurogenic Bladder Dysfunction, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder Dysfunction, Degenerative Cervical Spinal Stenosis
- How many people
- 225 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2023to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, 8008
Gergely David, Dr., +41 44 510 72 13, gergely.david@balgrist.ch
Christian Kuendig, MSc, +41 44 510 72 08, christian.kuendig@balgrist.ch
About this study
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.
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder Dysfunction, Degenerative Cervical Spinal Stenosis
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional study: healthy controls | Not described | |
| Cross-sectional study: chronic traumatic SCI patients | Not described | |
| Cross-sectional study: non-traumatic SCI patients with degenerative spondylotic myelopathy | Not described | |
| Longitudinal study: healthy controls | Not described | |
| Longitudinal study: acute traumatic SCI patients (< 2 months after SCI) | Not described | |
| Longitudinal study: patients with neurogenic lower urinary tract dysfunction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline only
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
Measured: Change from baseline at 2-month, 6-month, and 12-month
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)
Measured: Baseline only
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)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Secondary outcomes (54)
Cross-sectional study: diffusion MRI in the spinal cord
Directional diffusivities in the spinal cord (units of mm2/s)
Measured: Baseline only
Cross-sectional study: diffusion MRI in the spinal cord
Fractional anisotropy in the spinal cord (unitless)
Measured: Baseline only
Longitudinal study: diffusion MRI in the spinal cord
Directional diffusivities in the spinal cord, measured (units of mm2/s)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: diffusion MRI in the spinal cord
Fractional anisotropy in the spinal cord (unitless)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: structural MRI in spinal cord
Cross-sectional areas of the spinal cord gray and white matter (units of mm2)
Measured: Baseline only
Longitudinal study: structural MRI in spinal cord
Cross-sectional areas of the spinal cord gray and white matter (units of mm2)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus
Thickness of nerves and nerve roots (units of mm2)
Measured: Baseline only
Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus
Nerve entry points into the spinal cord (for determining neurological levels)
Measured: Baseline only
Longitudinal study: magnetic resonance neurography of the lumbosacral plexus
Thickness of nerves and nerve roots (units of mm2)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: magnetic resonance neurography of the lumbosacral plexus
Nerve entry points into the spinal cord (for determining neurological levels)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: diffusion MRI in the brain
Directional diffusivities in the brain (units of mm2/s)
Measured: Baseline only
Cross-sectional study: diffusion MRI in the brain
Fractional anisotropy in the brain (unitless)
Measured: Baseline only
Longitudinal study: diffusion MRI in the brain
Directional diffusivities in the brain (units of mm2/s)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: diffusion MRI in the brain
Fractional anisotropy in the brain (unitless)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: structural MRI in the brain
Cortical thickness (units of mm)
Measured: Baseline only
Cross-sectional study: structural MRI in the brain
Volumes of the brain gray and white matter (units of mm3)
Measured: Baseline only
Longitudinal study: structural MRI in the brain
Cortical thickness (units of mm)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: structural MRI in the brain
Volumes of the brain gray and white matter (units of mm3)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: nerve conduction study
Latencies of F waves (units of ms). Period between initial stimulation and F wave elicitation in the tibial and peroneal motor nerves.
Measured: Baseline only
Cross-sectional study: nerve conduction study
Amplitudes of F waves in the tibial and peroneal motor nerves (units of microV)
Measured: Baseline only
Cross-sectional study: nerve conduction study
Duration of F waves in the tibial and peroneal motor (units of ms)
Measured: Baseline only
Longitudinal study: nerve conduction study
Latencies of F waves (units of ms). Period between initial stimulation and F wave elicitation in the tibial and peroneal motor nerves.
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: nerve conduction study
Amplitudes of F waves in the tibial and peroneal motor nerves (units of microV)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: nerve conduction study
Duration of F waves in the tibial and peroneal motor (units of ms)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: motor evoked potentials (MEP)
Latencies (units of ms)
Measured: Baseline only
Cross-sectional study: motor evoked potentials (MEP)
Amplitudes (units of mV)
Measured: Baseline only
Longitudinal study: motor evoked potentials (MEP)
Latencies (units of ms)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: motor evoked potentials (MEP)
Amplitudes (units of mV)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
AIS quantifies the severity of the spinal cord injury. AIS (ASIA Impairment Scale) grades from A-E, whereas grade A (complete spinal cord injury) is worse than grade E (no impairment)
Measured: Baseline only
Cross-sectional study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
LEMS is based on assessments of ISNCSCI and composed from the sum of muscle function grading of the five key muscles of the lower limbs. It consists of a 6-point scale (0=no; 5=normal activity) for each muscle and body site. The lowest possible score in the total LEMS score for one body site is 0 (symptomatic); the highest possible score is 50 (asymptomatic)
Measured: Baseline only
Cross-sectional study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
UEMS is based on assessments of ISNCSCI and composed from the sum of muscle function grading of the five key muscles of the upper limbs. It consists of a 6-point scale (0=no; 5=normal activity) for each muscle and body site. The lowest possible score in the total UEMS score for one body site is 0 (symptomatic); the highest possible score is 50 (asymptomatic)
Measured: Baseline only
Cross-sectional study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
The LT score is based on assessments of ISNCSCI and represents the sum of sensory function of 28 dermatome pairs in terms of light touch sensation. It consists of a 2-point scale (0=absent sensation; 1=altered (impaired or partial sensation, including hyperesthesia); 2 = normal or intact sensation) for each dermatome and body site. The lowest and highest possible LT score for one body site is 0 and 56, respectively
Measured: Baseline only
Cross-sectional study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
The PP score is based on assessments of ISNCSCI and represents the sum of sensory function of 28 dermatome pairs in terms of pin prick discrimination. It consists of a 2-point scale (0=absent discrimination; 1=altered (impaired or partial discrimination); 2 = normal or intact discrimination) for each dermatome and body site. The lowest and highest possible PP score for one body site is 0 and 56, respectively
Measured: Baseline only
Longitudinal study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
AIS quantifies the severity of the spinal cord injury. AIS (ASIA Impairment Scale) grades from A-E, whereas grade A (complete spinal cord injury) is worse than grade E (no impairment).
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
LEMS is based on assessments of ISNCSCI and composed from the sum of muscle function grading of the five key muscles of the lower limbs. It consists of a 6-point scale (0=no; 5=normal activity) for each muscle and body site. The lowest possible score in the total LEMS score for one body site is 0 (symptomatic); the highest possible score is 50 (asymptomatic)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
UEMS is based on assessments of ISNCSCI and composed from the sum of muscle function grading of the five key muscles of the upper limbs. It consists of a 6-point scale (0=no; 5=normal activity) for each muscle and body site. The lowest possible score in the total UEMS score for one body site is 0 (symptomatic); the highest possible score is 50 (asymptomatic)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
The LT score is based on assessments of ISNCSCI and represents the sum of sensory function of 28 dermatome pairs in terms of light touch sensation. It consists of a 2-point scale (0=absent sensation; 1=altered (impaired or partial sensation, including hyperesthesia); 2 = normal or intact sensation) for each dermatome and body site. The lowest and highest possible LT score for one body site is 0 and 56, respectively
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
The PP score is based on assessments of ISNCSCI and represents the sum of sensory function of 28 dermatome pairs in terms of pin prick discrimination. It consists of a 2-point scale (0=absent discrimination; 1=altered (impaired or partial discrimination); 2 = normal or intact discrimination) for each dermatome and body site. The lowest and highest possible PP score for one body site is 0 and 56, respectively
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
GRASSP measures sensorimotor and prehension function through three domains (strength, sensation and prehension) which are important in describing arm and hand function. The total GRASSP score ranges from 0 to 116 points, where a higher score indicates a better outcome
Measured: Baseline only
Longitudinal study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
GRASSP measures sensorimotor and prehension function through three domains (strength, sensation and prehension) which are important in describing arm and hand function. The total GRASSP score ranges from 0 to 116 points, where a higher score indicates a better outcome
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: European Multicenter Study about SCI (EMSCI) pain questionnaire
The EMSCI pain questionnaire rates various aspects of pain (e.g., current pain intensity, mean and maximal pain intensity during the last week before the assessment, location and quality of pain, intensity of allodynia and paresthesia). Pain intensity is quantified on an 11-point numeric scale (0=no pain; 10=worst imaginable pain)
Measured: Baseline only
Longitudinal study: European Multicenter Study about SCI (EMSCI) pain questionnaire
The EMSCI pain questionnaire rates various aspects of pain (e.g., current pain intensity, mean and maximal pain intensity during the last week before the assessment, location and quality of pain, intensity of allodynia and paresthesia). Pain intensity is quantified on an 11-point numeric scale (0=no pain; 10=worst imaginable pain)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings
Latencies (units of ms)
Measured: Baseline only
Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings
Amplitudes (units of microV)
Measured: Baseline only
Longitudinal study: sympathetic skin response including hand, sole and perineum recordings
Latencies (units of ms)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: sympathetic skin response including hand, sole and perineum recordings
Amplitudes (units of microV)
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: Spinal Cord Independence Measure (SCIM III)
The SCIM-III ("Spinal Cord Independence Measure III") score is based on questions concerning independence of persons with a spinal cord injured. It consists of 19 items covering 3 domains, self-care, respiration and sphincter management, and mobility. The self-care subscale ranges from 0 to 20. The respiration and sphincter management subscale ranges from 0 to 40. The mobility subscale ranges from 0 to 40. Total score ranges from 0 (symptomatic) to 100 (asymptomatic). Higher scores reflect higher levels of independence.
Measured: Baseline only
Longitudinal study: Spinal Cord Independence Measure (SCIM III)
The SCIM-III ("Spinal Cord Independence Measure III") score is based on questions concerning independence of persons with a spinal cord injured. It consists of 19 items covering 3 domains, self-care, respiration and sphincter management, and mobility. The self-care subscale ranges from 0 to 20. The respiration and sphincter management subscale ranges from 0 to 40. The mobility subscale ranges from 0 to 40. Total score ranges from 0 (symptomatic) to 100 (asymptomatic). Higher scores reflect higher levels of independence
Measured: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: Walking index for Spinal Cord Injury (WISCI)
WISCI is an ordinal 20-point scale (0=unable to stand and/or participate in walking; 20=ambulates with no devices, with brace and no assistance) to assess walking function
Measured: Baseline only
Longitudinal study: Walking index for Spinal Cord Injury (WISCI)
WISCI is an ordinal 20-point scale (0=unable to stand and/or participate in walking; 20=ambulates with no devices, with brace and no assistance) to assess walking function
Measured: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: International Prostate Symptom Score (IPSS) (only in patients with neurogenic lower urinary tract dysfunction)
The IPSS score is based on questions concerning urinary symptoms and quality of life (QoL). It consists of 8 items covering 7 urinary symptoms related dimensions (subscales) and 1 additional item assessing quality of life. Each item is rated on a 6-point scale (0=not at all; 5=almost always). The lowest possible score in the total IPSS score is 0 (asymptomatic); the highest possible score is 35 (symptomatic). The QoL index is rated on a 7-point scale, with 0 indicating "delighted" and 6 "terrible"
Measured: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
Longitudinal study: Qualiveen questionnaire (only in patients with neurogenic lower urinary tract dysfunction)
Qualiveen-30 assesses the Specific Impact of Urinary Problems (SIUP) on Quality of Life. It consists of 30 items covering 4 domains, namely inconvenience (9 questions), restrictions (8 questions), fears (8 questions), and impact on daily life (5 questions). Each item is rated on a 5-point ordinal scale (0=asymptomatic; 4=symptomatic). The index of the SIUP on Quality of Life is the mean of the four individual scores. The lowest possible overall score in the Qualiveen-30 is 0 (Urinary problems have no specific impact on QoL); the highest possible score is 30 (Urinary problems have a huge specific impact on QoL)
Measured: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
Longitudinal study: Urinary Symptom Profile (USP) (only in patients with neurogenic lower urinary tract dysfunction)
The USP score is based on questions concerning urinary symptoms and their severity in males and females. It consists of 13 items covering 3 dimensions (subscales) with 7 overactive bladder (OAB), 3 stress urinary incontinence (SUI), and 3 low stream (LS) related items. Each item is rated on a 4-point scale. The lowest score is 0 (asymptomatic); the highest score is 3 (symptomatic)
Measured: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
Longitudinal study: Overactive Bladder (ICIQ-OAB) questionnaire (only in patients with neurogenic lower urinary tract dysfunction)
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life ICIQ-OAB-QoL is a 26-item questionnaire evaluating quality of life (QoL) in patients with overactive bladder. Scores range from 25-160, with greater values indicating increased impact on quality of life
Measured: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Paraplegic Research, Nottwil
- Responsible party
- Sponsor
- Investigators
- Patrick Freund, Prof. Dr. med. Dr. rer. nat., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681936
- Sponsor's protocol ID
- 2022-00558
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05681936
- Acronym / sponsor ID
- 2022-00558
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder Dysfunction, Degenerative Cervical Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Paraplegic Research, Nottwil
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional study: healthy controls | – | – |
| Cross-sectional study: chronic traumatic SCI patients | – | – |
| Cross-sectional study: non-traumatic SCI patients with degenerative spondylotic myelopathy | – | – |
| Longitudinal study: healthy controls | – | – |
| Longitudinal study: acute traumatic SCI patients (< 2 months after SCI) | – | – |
| Longitudinal study: patients with neurogenic lower urinary tract dysfunction | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Age > 18 years
- Informed consent
- Willing to take part and follow requirements of the protocol
- Chronic traumatic SCI (> 12 months after injury) or
- Diagnosed degenerative spondylotic myelopathy (DCM)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-sectional study: lumbosacral functional fMRI
Time frame: Baseline only
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
Longitudinal study: lumbosacral functional fMRI
Time frame: Change from baseline at 2-month, 6-month, and 12-month
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
Cross-sectional study: brain functional MRI
Time frame: Baseline only
Activations in the cortical and subcortical areas of the brain as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state)
Longitudinal study: brain functional MRI
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Activations in the cortical and subcortical areas of the brain as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state)
54 secondary outcomes
Cross-sectional study: diffusion MRI in the spinal cord
Time frame: Baseline only
Cross-sectional study: diffusion MRI in the spinal cord
Time frame: Baseline only
Longitudinal study: diffusion MRI in the spinal cord
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: diffusion MRI in the spinal cord
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: structural MRI in spinal cord
Time frame: Baseline only
Longitudinal study: structural MRI in spinal cord
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus
Time frame: Baseline only
Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus
Time frame: Baseline only
Longitudinal study: magnetic resonance neurography of the lumbosacral plexus
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: magnetic resonance neurography of the lumbosacral plexus
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: diffusion MRI in the brain
Time frame: Baseline only
Cross-sectional study: diffusion MRI in the brain
Time frame: Baseline only
Longitudinal study: diffusion MRI in the brain
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: diffusion MRI in the brain
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: structural MRI in the brain
Time frame: Baseline only
Cross-sectional study: structural MRI in the brain
Time frame: Baseline only
Longitudinal study: structural MRI in the brain
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: structural MRI in the brain
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: nerve conduction study
Time frame: Baseline only
Cross-sectional study: nerve conduction study
Time frame: Baseline only
Cross-sectional study: nerve conduction study
Time frame: Baseline only
Longitudinal study: nerve conduction study
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: nerve conduction study
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: nerve conduction study
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: motor evoked potentials (MEP)
Time frame: Baseline only
Cross-sectional study: motor evoked potentials (MEP)
Time frame: Baseline only
Longitudinal study: motor evoked potentials (MEP)
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: motor evoked potentials (MEP)
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Baseline only
Cross-sectional study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Baseline only
Cross-sectional study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Baseline only
Cross-sectional study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Baseline only
Cross-sectional study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Baseline only
Longitudinal study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Longitudinal study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Cross-sectional study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
Time frame: Baseline only
Longitudinal study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
Time frame: Change from baseline at 2-month, 6-month, and 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Freund, Prof. Dr. med. Dr. rer. nat. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Neurogenic Bladder Dysfunction, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gergely David, Dr. (+41 44 510 72 13, gergely.david@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional study: lumbosacral functional fMRI (time frame: Baseline only). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.