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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 : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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 Phase
Spinal Cord Injuries Diagnostic Test: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional, Structural, and Metabolic Central Nervous System Changes Following Spinal Cord Injury
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


Arm Intervention/treatment
Active Comparator: Patients with spinal cord injury Diagnostic Test: MRI
We will examine chronic (>6 months post SCI) paraplegic and tetraplegic patients using MRI and fMRI in both the brain and the spinal cord. In the spinal cord and brain, structural and metabolic measurements are planned.

Active Comparator: Healthy subjects Diagnostic Test: MRI
We will examine chronic (>6 months post SCI) paraplegic and tetraplegic patients using MRI and fMRI in both the brain and the spinal cord. In the spinal cord and brain, structural and metabolic measurements are planned.




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 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 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 chronic SCI patients and compared to healthy controls



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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
Criteria

Inclusion Criteria - Patients:

  • Age 18-70
  • 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 rbody duntion impairments not induced by spinal cord injury
  • BMI > 40
  • Pregnancy
  • Claustrophobia

Inclusion Criteria - Healthy subjects:

  • Age 18-70
  • 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

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 dario.pfyffer@balgrist.ch
Contact: Sanne Kikkert +41 44 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

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03772548     History of Changes
Other Study ID Numbers: 2018-00937
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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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