<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03772548</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00937 - SCI</org_study_id>
    <nct_id>NCT03772548</nct_id>
  </id_info>
  <brief_title>CNS Changes Following SCI</brief_title>
  <official_title>Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to better understand the structural and functional changes&#xD;
      that the central nervous system (CNS) undergoes following spinal cord injury and how these&#xD;
      changes relate to clinical measures. Both macroscopic and microscopic changes of the brain&#xD;
      and the spinal cord will be examined in SCI patients and compared to healthy controls. In&#xD;
      terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the&#xD;
      course of the patient's neurological status and accurately describe the course of the disease&#xD;
      and the recovery. Importantly, we aim to investigate which factors scale the patients'&#xD;
      symptoms. In terms of functional plasticity, we will combine fMRI with behavioural testing to&#xD;
      understand which clinical and behavioural determinants drive functional hand representations&#xD;
      in the primary somatosensory and motor cortices to be maintained and which determinants drive&#xD;
      reorganisation of functional representations following sensory input loss. We will further&#xD;
      investigate the contribution of brainstem reorganisation to plasticity observed at the&#xD;
      cortical level and, by doing so, aim to better understand the mechanistic underpinnings of&#xD;
      functional reorganisation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 18, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Conventional magnetic resonance imaging (MRI) parameter</measure>
    <time_frame>Up to 50 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance spectroscopy (MRS) parameter</measure>
    <time_frame>Up to 50 weeks</time_frame>
    <description>Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of functional MRI (fMRI) parameter between 2 to 4 time points</measure>
    <time_frame>Up to 50 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">285</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Patients with spinal cord injury</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>We will examine acute (&lt;4 weeks post SCI) to chronic (&gt;6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.</description>
    <arm_group_label>Patients with spinal cord injury</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with spinal cord injury and healthy subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria - Patients:&#xD;
&#xD;
          -  Age 18-75&#xD;
&#xD;
          -  Traumatic or non-traumatic spinal cord injury (para- and tetraplegia)&#xD;
&#xD;
          -  Acute (&lt;4 weeks post SCI) to chronic SCI (&gt; 6 months post SCI)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria - Patients:&#xD;
&#xD;
          -  Contraindications to magnetic resonance imaging&#xD;
&#xD;
          -  Neurological impairment of body function impairments not induced by spinal cord injury&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
        Inclusion Criteria - Healthy subjects:&#xD;
&#xD;
          -  Age 18-75&#xD;
&#xD;
          -  Signed Informed consent&#xD;
&#xD;
        Exclusion Criteria - Healthy subjects:&#xD;
&#xD;
          -  Contraindications to magnetic resonance imaging&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neurological illness&#xD;
&#xD;
          -  Impairment of body function induced by a spinal cord injury&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armin Curt</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Simon Schading, MMed</last_name>
    <phone>+41 44 510 72 08</phone>
    <email>simon.schading@balgrist.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sanne Kikkert</last_name>
    <phone>+41 44 633 27 15</phone>
    <email>sanne.kikkert@balgrist.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitätsklinik Balgrist</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Schading, MMed</last_name>
      <email>simon.schading@balgrist.ch</email>
    </contact>
    <contact_backup>
      <last_name>Sanne Kikkert</last_name>
      <email>sanne.kikkert@balgrist.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03772548
org study id: 2018-00937 - SCI
nct id: NCT03772548
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Prospective
measure: Conventional magnetic resonance imaging (MRI) parameter
time frame: Up to 50 weeks
description: 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
measure: Magnetic resonance spectroscopy (MRS) parameter
time frame: Up to 50 weeks
description: Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls
measure: Change of functional MRI (fMRI) parameter between 2 to 4 time points
time frame: Up to 50 weeks
description: 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
arm group label: Patients with spinal cord injury
arm group label: Healthy subjects
intervention type: Diagnostic Test
intervention name: MRI
description: 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.
arm group label: Patients with spinal cord injury
intervention type: Diagnostic Test
intervention name: MRI
description: We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.
arm group label: Healthy subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Armin Curt
role: Principal Investigator
affiliation: University of Zurich
last name: Simon Schading, MMed
phone: +41 44 510 72 08
email: simon.schading@balgrist.ch
last name: Sanne Kikkert
phone: +41 44 633 27 15
email: sanne.kikkert@balgrist.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor
mesh term: Spinal Cord Injuries