<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/NCT03753945</url>
  </required_header>
  <id_info>
    <org_study_id>18-6176</org_study_id>
    <nct_id>NCT03753945</nct_id>
  </id_info>
  <brief_title>Spine MRI in Patients With Deep Brain Stimulation (DBS)</brief_title>
  <official_title>Spine MRI in Patients With Deep Brain Stimulation (DBS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is&#xD;
      under strict safety guidelines. Depending on the body part being imaged, the safety may vary.&#xD;
&#xD;
      Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor&#xD;
      safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom&#xD;
      safety data, we designed a set of MR pulse sequences deemed as safe as possible and the&#xD;
      protocol allows acquisition of diagnostic quality MRI images.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients who clinically require a spine MRI will undergo a spine MRI with our designed&#xD;
      protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done&#xD;
      before and after to ensure no peri-electrode tissue changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">January 21, 2022</completion_date>
  <primary_completion_date type="Actual">January 21, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective cohort study that will enroll patients who have already undergone DBS electrode placement for a variety of disorders including, but not limited to Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain and Alzheimer's disease. This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of MRI-related Adverse Events [Safety]</measure>
    <time_frame>Immediately after the MRI</time_frame>
    <description>Assess for adverse events as seen on clinical examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Peri-electrode Tissue Changes (MRI)</measure>
    <time_frame>Immediately after the MRI</time_frame>
    <description>Assess for peri-electrode tissue changes as seen on MRI</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Dystonia</condition>
  <condition>Depression</condition>
  <condition>Spinal Stenosis</condition>
  <condition>Spinal Diseases</condition>
  <arm_group>
    <arm_group_label>DBS electrode placement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this study will be patients who have already undergone surgery for implantation of DBS electrodes.&#xD;
Patients who have already undergone surgery for implantation of DBS electrodes and patients for whom the treating physicians recommends (based on clinical grounds) a spine MRI (cervical, thoracic or lumbar) shall be recruited for the study.This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI of the spine</intervention_name>
    <description>Perform a clinically indicated MRI of the spine in DBS patients</description>
    <arm_group_label>DBS electrode placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Age between 18 and 85 years of age&#xD;
&#xD;
          -  Participants must have undergone implantation of DBS electrodes.&#xD;
&#xD;
          -  Participants must be able to understand the purpose of this research and must sign the&#xD;
             informed consent form.&#xD;
&#xD;
          -  Participants must understand that the role of this research is demonstrate the safety&#xD;
             of spine MRI in patients with DBS.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Participants who have serious cognitive or psychological impairments and cannot give&#xD;
             informed consent.&#xD;
&#xD;
          -  Participants who are unable to effectively or efficiently communicate, for example&#xD;
             patients suffering from speech deficits (dysarthria, aphasia) or are non-English&#xD;
             speaking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres Lozano</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Andres M. Lozano</investigator_full_name>
    <investigator_title>Neurosurgeon</investigator_title>
  </responsible_party>
  <keyword>deep brain stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dystonia</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/NCT03753945
org study id: 18-6176
nct id: NCT03753945
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is
      under strict safety guidelines. Depending on the body part being imaged, the safety may vary.

      Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor
      safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom
      safety data, we designed a set of MR pulse sequences deemed as safe as possible and the
      protocol allows acquisition of diagnostic quality MRI images.
The patients who clinically require a spine MRI will undergo a spine MRI with our designed
      protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done
      before and after to ensure no peri-electrode tissue changes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective cohort study that will enroll patients who have already undergone DBS electrode placement for a variety of disorders including, but not limited to Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain and Alzheimer's disease. This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of MRI-related Adverse Events [Safety]
time frame: Immediately after the MRI
description: Assess for adverse events as seen on clinical examination
measure: Assessment of Peri-electrode Tissue Changes (MRI)
time frame: Immediately after the MRI
description: Assess for peri-electrode tissue changes as seen on MRI
arm group label: DBS electrode placement
arm group type: Experimental
description: Participants in this study will be patients who have already undergone surgery for implantation of DBS electrodes.
Patients who have already undergone surgery for implantation of DBS electrodes and patients for whom the treating physicians recommends (based on clinical grounds) a spine MRI (cervical, thoracic or lumbar) shall be recruited for the study.This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.
intervention type: Diagnostic Test
intervention name: MRI of the spine
description: Perform a clinically indicated MRI of the spine in DBS patients
arm group label: DBS electrode placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andres Lozano
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Andres M. Lozano
investigator title: Neurosurgeon
mesh term: Spinal Stenosis
mesh term: Spinal Diseases
mesh term: Parkinson Disease
mesh term: Dystonia