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CNS Changes Following SCI

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ClinicalTrials.gov Identifier: NCT03772548
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following spinal cord injury and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in SCI patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms. In terms of functional plasticity, we will combine fMRI with behavioural testing to understand which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.

Condition or disease Intervention/treatment
Spinal Cord Injuries Diagnostic Test: MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 285 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with spinal cord injury Diagnostic Test: MRI
We will examine acute (<4 weeks post SCI) to chronic (>6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
Healthy subjects Diagnostic Test: MRI
We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.


Outcome Measures
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Primary Outcome Measures :
  1. Conventional magnetic resonance imaging (MRI) parameter [ Time Frame: Up to 50 weeks ]
    Structural characteristics in the brain and cervical spinal cord are assessed in acute to chronic spinal cord injury (SCI) patients using conventional MRI and compared to healthy controls


Secondary Outcome Measures :
  1. Magnetic resonance spectroscopy (MRS) parameter [ Time Frame: Up to 50 weeks ]
    Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls

  2. Change of functional MRI (fMRI) parameter between 2 to 4 time points [ Time Frame: Up to 50 weeks ]
    Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in acute to chronic SCI patients and compared to healthy controls


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with spinal cord injury and healthy subjects.
Criteria

Inclusion Criteria - Patients:

  • Age 18-75
  • Traumatic or non-traumatic spinal cord injury (para- and tetraplegia)
  • Acute (<4 weeks post SCI) to chronic SCI (> 6 months post SCI)
  • Signed informed consent

Exclusion Criteria - Patients:

  • Contraindications to magnetic resonance imaging
  • Neurological impairment of body function impairments not induced by spinal cord injury
  • BMI > 40
  • Pregnancy
  • Claustrophobia

Inclusion Criteria - Healthy subjects:

  • Age 18-75
  • Signed Informed consent

Exclusion Criteria - Healthy subjects:

  • Contraindications to magnetic resonance imaging
  • Pregnancy
  • Neurological illness
  • Impairment of body function induced by a spinal cord injury
  • Claustrophobia
  • BMI > 40
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): NCT03772548


Contacts
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Contact: Dario Pfyffer +41 44 510 72 08 dario.pfyffer@balgrist.ch
Contact: Sanne Kikkert +41 44 633 27 15 sanne.kikkert@balgrist.ch

Locations
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Switzerland
Universitätsklinik Balgrist Recruiting
Zürich, Switzerland, 8008
Contact: Dario Pfyffer       dario.pfyffer@balgrist.ch   
Contact: Sanne Kikkert       sanne.kikkert@balgrist.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Armin Curt University of Zurich
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03772548    
Other Study ID Numbers: 2018-00937 - SCI
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021

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