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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 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date November 21, 2018
First Posted Date December 11, 2018
Last Update Posted Date July 16, 2020
Actual Study Start Date July 18, 2018
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2018)
Conventional magnetic resonance imaging (MRI) parameter [ Time Frame: Up to 50 weeks ]
Structural characteristics in the brain and cervical spinal cord are assessed in chronic spinal cord injury (SCI) patients using conventional MRI and compared to healthy controls
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 10, 2018)
  • Magnetic resonance spectroscopy (MRS) parameter [ Time Frame: Up to 50 weeks ]
    Metabolic parameters are assessed in chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls
  • 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 chronic SCI patients and compared to healthy controls
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CNS Changes Following SCI
Official Title Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with spinal cord injury and healthy subjects.
Condition Spinal Cord Injuries
Intervention
  • Diagnostic Test: MRI
    We will examine chronic (>6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
  • Diagnostic Test: MRI
    We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.
Study Groups/Cohorts
  • Patients with spinal cord injury
    Intervention: Diagnostic Test: MRI
  • Healthy subjects
    Intervention: Diagnostic Test: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 10, 2018)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria - Patients:

  • Age 18-75
  • Traumatic or non-traumatic spinal cord injury (para- and tetraplegia)
  • Chronic SCI (> 6months since injury)
  • Signed informed consent

Exclusion Criteria - Patients:

  • Contraindications to magnetic resonance imaging
  • Neurological impairment of body funtion 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Dario Pfyffer +41 44 510 72 08 dario.pfyffer@balgrist.ch
Contact: Sanne Kikkert +41 44 633 27 15 sanne.kikkert@balgrist.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03772548
Other Study ID Numbers 2018-00937 - SCI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Principal Investigator: Armin Curt University of Zurich
PRS Account University of Zurich
Verification Date July 2020