<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/NCT03834857</url>
  </required_header>
  <id_info>
    <org_study_id>S-01-01</org_study_id>
    <nct_id>NCT03834857</nct_id>
  </id_info>
  <brief_title>SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device</brief_title>
  <official_title>Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study (EFS) of the Safety of the Stentrode Device in Participants With Loss of Motor Function Due to Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Synchron Australia Pty Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Synchron, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SWITCH Study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the&#xD;
      safety of the StentrodeTM device in participants with loss of motor function due to paralysis&#xD;
      from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs.&#xD;
&#xD;
      Research has shown that in individuals with neurological conditions, brain signals can be&#xD;
      recorded using electrical sensors implanted on to the brain. These signals could be used by&#xD;
      the individuals to control assistive technology (e.g. spelling devices) that help with daily&#xD;
      life, just by thinking. However, implanting these electrical sensors often requires open&#xD;
      brain surgery.&#xD;
&#xD;
      A new medical device and surgical technique has been developed, which allows implantation of&#xD;
      the electrical sensors without open brain surgery. The device, called Stentrode™, is a small&#xD;
      metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent&#xD;
      structure. It can be placed inside a blood vessel of the brain located in the motor cortex.&#xD;
      This does not involve open brain surgery.&#xD;
&#xD;
      The purpose of this research is to evaluate the safety of the Stentrode™ device in humans.&#xD;
      This is an experimental device. This research will be the first of its kind to be performed&#xD;
      in humans and may help find safer, more effective ways to introduce/implant electrical&#xD;
      sensors in patients. This could foster the development of user friendly biotechnology for&#xD;
      patients with neurological conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2019</start_date>
  <completion_date type="Actual">January 9, 2022</completion_date>
  <primary_completion_date type="Actual">December 10, 2021</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>Insertion of Stentrode TM device</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-Related Adverse Events</measure>
    <time_frame>12 month post implant</time_frame>
    <description>Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High fidelity and stable signals over 12 months</measure>
    <time_frame>36 months</time_frame>
    <description>The mean and standard deviation (SD) of first three measurements of impedance values across all 16 channels, excluding flag values, to a maximum of 10 measurements&#xD;
The mean and SD of noise floor calculated from 2 mins of baseline recording&#xD;
The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Neurologic Disorder</condition>
  <arm_group>
    <arm_group_label>single</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Implantation of Stentrode device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stentrode</intervention_name>
    <description>Implantation of Stentrode device</description>
    <arm_group_label>single</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of spinal cord injury (SCI), motor neurone disease (MND) [also&#xD;
             known as amyotrophic lateral sclerosis (ALS)], stroke, muscular dystrophy or loss of&#xD;
             limbs.&#xD;
&#xD;
          2. Diagnosed for at least six (6) months and if SCI, at least twelve (12) months&#xD;
&#xD;
          3. Aged between 18 and 75 years of age; females must be of non-child bearing potential or&#xD;
             with negative pregnancy test and not breast feeding&#xD;
&#xD;
          4. Life expectancy of at least twelve (12) months in the opinion of the treating&#xD;
             physician&#xD;
&#xD;
          5. Understands English&#xD;
&#xD;
          6. Is computer literate&#xD;
&#xD;
          7. Is willing and able to access all clinical testing locations and is not impeded by&#xD;
             geographical location (ie: ideally lives within 100 kms or Less than 2 hours travel&#xD;
             time to study site)&#xD;
&#xD;
          8. No conditions, including an eye movement disorder, that would prevent the use of eye&#xD;
             tracking software and has a level of vision that will not impede viewing of screens&#xD;
             and visualisations&#xD;
&#xD;
          9. Has normal venous sinus anatomy, with two patent jugular veins (of sufficient size for&#xD;
             the device) and bilateral patent transverse sinuses as evidenced by MR venography&#xD;
             (MRV) or CT venography (CTV) within the last six (6) months or if vascular anatomy is&#xD;
             unknown, is willing to undergo an MRV or CTV assessment to assess vascular suitability&#xD;
             for endovascular device placement&#xD;
&#xD;
         10. Evidence of activation, under fMRI testing, of motor cortical areas adjacent to the&#xD;
             superior sagittal sinus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is unwilling to comply with all procedures relating to study&#xD;
&#xD;
          2. Based on the doctors opinion, has unrealistic expectations regarding the possible&#xD;
             benefits, risks and limitations associated with the implantation or surgical&#xD;
             procedures&#xD;
&#xD;
          3. Has dementia or cognitive impairment sufficient to impair capacity to provide informed&#xD;
             consent or which could impact ability to comply with investigational requirements (eg:&#xD;
             MMSE &lt;24, ECAS or other determination made by Investigator)&#xD;
&#xD;
          4. For MND participants, has NOT had a formal capacity assessment by a professional with&#xD;
             experience in capacity assessment (psychiatrist, neurologist, psychologist) within 90&#xD;
             days of Screen1 visit, which assesses capacity to consent and excludes Frontotemporal&#xD;
             dementia&#xD;
&#xD;
          5. Has a history of substance abuse within the preceding two (2) years&#xD;
&#xD;
          6. Chronic oral or intravenous steroids or immunosuppressive therapy or other&#xD;
             therapy/clinical condition that severely reduces immunity Has been hospitalized for a&#xD;
             psychiatric condition with the preceding two (2) years or has had a history of&#xD;
             psychosis within the preceding two (2) years&#xD;
&#xD;
          7. Has a contraindication to magnetic resonance imaging (MRI)&#xD;
&#xD;
          8. Has an active implanted stimulation device (eg: pacemaker, deep brain stimulator,&#xD;
             spinal cord stimulator)&#xD;
&#xD;
          9. Is deemed unsuitable by a specialist anaesthesiologist or respiratory physician to&#xD;
             undergo a general anaesthetic&#xD;
&#xD;
         10. Has findings on MRV deemed incompatible, by an experienced neurointerventionalist,&#xD;
             with device implantation in the SSS [eg: isolated dominant, superior anastomotic vein&#xD;
             (vein of Trolard)]&#xD;
&#xD;
         11. Has a contraindication to angiographic imaging, including chronic kidney injury (CKI&#xD;
             -eGFR &lt; 60mls/min)&#xD;
&#xD;
         12. Has known allergy to contrast media&#xD;
&#xD;
         13. Has any bleeding disorders (tests required if clinical status unknown) or is resistant&#xD;
             to aspirin and/or clopidogrel or has any contraindication that precludes&#xD;
             antithrombotic treatment&#xD;
&#xD;
         14. Has an allergy to any materials included in the implanted device&#xD;
&#xD;
         15. Has a history of Deep Vein Thrombosis (DVT) or on hormone therapy (eg: HRT)&#xD;
&#xD;
         16. Any serious disease or disorder that in the opinion of the Investigator, could&#xD;
             seriously affect ability to participate in the study&#xD;
&#xD;
         17. Does not have a family member/caregiver (or equivalent) who can be present during the&#xD;
             consent process and support all study visits&#xD;
&#xD;
         18. Has had any of the following neuropathologies;&#xD;
&#xD;
               1. Sinus Thrombosis&#xD;
&#xD;
               2. Venous Hypertension&#xD;
&#xD;
               3. Hydrocephalus&#xD;
&#xD;
               4. Bleeding Disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Oxley</last_name>
    <role>Study Director</role>
    <affiliation>University of Melbourne and Synchron</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>August 29, 2022</last_update_submitted>
  <last_update_submitted_qc>August 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</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>Nervous System Diseases</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/NCT03834857
org study id: S-01-01
nct id: NCT03834857
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
SWITCH Study
STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the
      safety of the StentrodeTM device in participants with loss of motor function due to paralysis
      from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs.

      Research has shown that in individuals with neurological conditions, brain signals can be
      recorded using electrical sensors implanted on to the brain. These signals could be used by
      the individuals to control assistive technology (e.g. spelling devices) that help with daily
      life, just by thinking. However, implanting these electrical sensors often requires open
      brain surgery.

      A new medical device and surgical technique has been developed, which allows implantation of
      the electrical sensors without open brain surgery. The device, called Stentrode™, is a small
      metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent
      structure. It can be placed inside a blood vessel of the brain located in the motor cortex.
      This does not involve open brain surgery.

      The purpose of this research is to evaluate the safety of the Stentrode™ device in humans.
      This is an experimental device. This research will be the first of its kind to be performed
      in humans and may help find safer, more effective ways to introduce/implant electrical
      sensors in patients. This could foster the development of user friendly biotechnology for
      patients with neurological conditions.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Insertion of Stentrode TM device
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Treatment-Related Adverse Events
time frame: 12 month post implant
description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
measure: High fidelity and stable signals over 12 months
time frame: 36 months
description: The mean and standard deviation (SD) of first three measurements of impedance values across all 16 channels, excluding flag values, to a maximum of 10 measurements
The mean and SD of noise floor calculated from 2 mins of baseline recording
The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation
arm group label: single
arm group type: Other
description: Implantation of Stentrode device
intervention type: Device
intervention name: Stentrode
description: Implantation of Stentrode device
arm group label: single
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Thomas Oxley
role: Study Director
affiliation: University of Melbourne and Synchron
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Nervous System Diseases