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

NCT05681936 | Recruiting

• 1 other identifier: 2022-00558
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Neurogenic Bladder Dysfunction; Degenerative Cervical Spinal Stenosis

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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)

  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)

  Change from baseline at 2-month, 6-month, and 12-month

Secondary Outcomes (54)

• Cross-sectional study: diffusion MRI in the spinal cord

  Baseline only

• Cross-sectional study: diffusion MRI in the spinal cord

  Baseline only

• Longitudinal study: diffusion MRI in the spinal cord

  Change from baseline at 2-month, 6-month, and 12-month

• Longitudinal study: diffusion MRI in the spinal cord

  Change from baseline at 2-month, 6-month, and 12-month

• Cross-sectional study: structural MRI in spinal cord

  Baseline only

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years
• Informed consent
• Willing to take part and follow requirements of the protocol
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator
• Swiss Paraplegic Research, Nottwil: collaborator

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Patrick Freund, Prof. Dr. med. Dr. rer. nat.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gergely David, Dr.

CONTACT

+41 44 510 72 13; gergely.david@balgrist.ch

Christian Kuendig, MSc

CONTACT

+41 44 510 72 08; christian.kuendig@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CH (1)