Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05681936

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Degenerative Cervical Spinal Stenosis Nervous System Diseases Neurogenic Bladder Dysfunction Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

Secondary outcomes

  1. Cross-sectional study: diffusion MRI in the spinal cord

    Time frame: Baseline only

    Directional diffusivities in the spinal cord (units of mm2/s)

  2. Cross-sectional study: diffusion MRI in the spinal cord

    Time frame: Baseline only

    Fractional anisotropy in the spinal cord (unitless)

  3. Longitudinal study: diffusion MRI in the spinal cord

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Directional diffusivities in the spinal cord, measured (units of mm2/s)

  4. Longitudinal study: diffusion MRI in the spinal cord

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Fractional anisotropy in the spinal cord (unitless)

  5. Cross-sectional study: structural MRI in spinal cord

    Time frame: Baseline only

    Cross-sectional areas of the spinal cord gray and white matter (units of mm2)

  6. Longitudinal study: structural MRI in spinal cord

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Cross-sectional areas of the spinal cord gray and white matter (units of mm2)

  7. Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus

    Time frame: Baseline only

    Thickness of nerves and nerve roots (units of mm2)

  8. Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus

    Time frame: Baseline only

    Nerve entry points into the spinal cord (for determining neurological levels)

  9. Longitudinal study: magnetic resonance neurography of the lumbosacral plexus

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Thickness of nerves and nerve roots (units of mm2)

  10. Longitudinal study: magnetic resonance neurography of the lumbosacral plexus

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Nerve entry points into the spinal cord (for determining neurological levels)

  11. Cross-sectional study: diffusion MRI in the brain

    Time frame: Baseline only

    Directional diffusivities in the brain (units of mm2/s)

  12. Cross-sectional study: diffusion MRI in the brain

    Time frame: Baseline only

    Fractional anisotropy in the brain (unitless)

  13. Longitudinal study: diffusion MRI in the brain

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Directional diffusivities in the brain (units of mm2/s)

  14. Longitudinal study: diffusion MRI in the brain

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Fractional anisotropy in the brain (unitless)

  15. Cross-sectional study: structural MRI in the brain

    Time frame: Baseline only

    Cortical thickness (units of mm)

  16. Cross-sectional study: structural MRI in the brain

    Time frame: Baseline only

    Volumes of the brain gray and white matter (units of mm3)

  17. Longitudinal study: structural MRI in the brain

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Cortical thickness (units of mm)

  18. Longitudinal study: structural MRI in the brain

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Volumes of the brain gray and white matter (units of mm3)

  19. Cross-sectional study: nerve conduction study

    Time frame: Baseline only

    Latencies of F waves (units of ms). Period between initial stimulation and F wave elicitation in the tibial and peroneal motor nerves.

  20. Cross-sectional study: nerve conduction study

    Time frame: Baseline only

    Amplitudes of F waves in the tibial and peroneal motor nerves (units of microV)

  21. Cross-sectional study: nerve conduction study

    Time frame: Baseline only

    Duration of F waves in the tibial and peroneal motor (units of ms)

  22. Longitudinal study: nerve conduction study

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Latencies of F waves (units of ms). Period between initial stimulation and F wave elicitation in the tibial and peroneal motor nerves.

  23. Longitudinal study: nerve conduction study

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Amplitudes of F waves in the tibial and peroneal motor nerves (units of microV)

  24. Longitudinal study: nerve conduction study

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Duration of F waves in the tibial and peroneal motor (units of ms)

  25. Cross-sectional study: motor evoked potentials (MEP)

    Time frame: Baseline only

    Latencies (units of ms)

  26. Cross-sectional study: motor evoked potentials (MEP)

    Time frame: Baseline only

    Amplitudes (units of mV)

  27. Longitudinal study: motor evoked potentials (MEP)

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Latencies (units of ms)

  28. Longitudinal study: motor evoked potentials (MEP)

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Amplitudes (units of mV)

  29. 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

    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)

  30. 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

    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)

  31. 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

    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)

  32. Cross-sectional study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol

    Time frame: Baseline only

    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

  33. Cross-sectional study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol

    Time frame: Baseline only

    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

  34. 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

    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).

  35. 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

    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)

  36. 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

    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)

  37. 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

    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

  38. 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

    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

  39. Cross-sectional study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)

    Time frame: Baseline only

    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

  40. 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

    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

  41. Cross-sectional study: European Multicenter Study about SCI (EMSCI) pain questionnaire

    Time frame: Baseline only

    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)

  42. Longitudinal study: European Multicenter Study about SCI (EMSCI) pain questionnaire

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    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)

  43. Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings

    Time frame: Baseline only

    Latencies (units of ms)

  44. Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings

    Time frame: Baseline only

    Amplitudes (units of microV)

  45. Longitudinal study: sympathetic skin response including hand, sole and perineum recordings

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Latencies (units of ms)

  46. Longitudinal study: sympathetic skin response including hand, sole and perineum recordings

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    Amplitudes (units of microV)

  47. Cross-sectional study: Spinal Cord Independence Measure (SCIM III)

    Time frame: Baseline only

    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.

  48. Longitudinal study: Spinal Cord Independence Measure (SCIM III)

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    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

  49. Cross-sectional study: Walking index for Spinal Cord Injury (WISCI)

    Time frame: Baseline only

    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

  50. Longitudinal study: Walking index for Spinal Cord Injury (WISCI)

    Time frame: Change from baseline at 2-month, 6-month, and 12-month

    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

  51. Longitudinal study: International Prostate Symptom Score (IPSS) (only in patients with neurogenic lower urinary tract dysfunction)

    Time frame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)

    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"

  52. Longitudinal study: Qualiveen questionnaire (only in patients with neurogenic lower urinary tract dysfunction)

    Time frame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)

    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)

  53. Longitudinal study: Urinary Symptom Profile (USP) (only in patients with neurogenic lower urinary tract dysfunction)

    Time frame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)

    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)

  54. Longitudinal study: Overactive Bladder (ICIQ-OAB) questionnaire (only in patients with neurogenic lower urinary tract dysfunction)

    Time frame: Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Kuendig, MSc

CONTACT

[email protected]

+41 44 510 72 08

Gergely David, Dr.

CONTACT

[email protected]

+41 44 510 72 13

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss National Science Foundation
  • Swiss Paraplegic Research, Nottwil

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.