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Recruiting NCT05681936

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

— Observational Spinal Cord Injuries Neurogenic Bladder Dysfunction Degenerative Cervical Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries, Neurogenic Bladder Dysfunction, Degenerative Cervical Spinal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Cross-sectional study: lumbosacral functional fMRI [Time frame: Baseline only]
  • Longitudinal study: lumbosacral functional fMRI [Time frame: Change from baseline at 2-month, 6-month, and 12-month]
  • Cross-sectional study: brain functional MRI [Time frame: Baseline only]
  • Longitudinal study: brain functional MRI [Time frame: Change from baseline at 2-month, 6-month, and 12-month]
Secondary outcome measures (12)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Balgrist University Hospital — Zurich

Identifiers

NCT: NCT05681936 · 2022-00558

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗