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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05681936
Recruitment Status : Recruiting
First Posted : January 12, 2023
Last Update Posted : January 12, 2023
Sponsor:
Collaborators:
Swiss National Science Foundation
Swiss Paraplegic Research
Information provided by (Responsible Party):
University of Zurich

Study Description
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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.

Condition or disease
Spinal Cord Injuries Neurogenic Bladder Dysfunction Degenerative Cervical Spinal Stenosis

Study Design
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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05681936


Contacts
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Contact: Gergely David, Dr. +41 44 510 72 13 gergely.david@balgrist.ch
Contact: Christian Kuendig, MSc +41 44 510 72 08 christian.kuendig@balgrist.ch

Locations
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Switzerland
Balgrist University Hospital Recruiting
Zurich, Switzerland, 8008
Contact: Gergely David, Dr.    +41 44 510 72 13    gergely.david@balgrist.ch   
Contact: Christian Kuendig, MSc    +41 44 510 72 08    christian.kuendig@balgrist.ch   
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Swiss Paraplegic Research
Investigators
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Principal Investigator: Patrick Freund, Prof. Dr. med. Dr. rer. nat. University of Zurich
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT05681936    
Other Study ID Numbers: 2022-00558
First Posted: January 12, 2023    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Spinal Diseases
 Bone Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases