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

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Enrolling

Conditions

Spinal Cord Injuries
Degenerative Cervical Spinal Stenosis
Neurogenic Bladder Dysfunction

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT05681936
2022-00558

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

225 participants in 6 patient groups

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

Trial contacts and locations

1

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Central trial contact

Gergely David, Dr.; Christian Kuendig, MSc

Data sourced from clinicaltrials.gov

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