<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/NCT04440709</url>
  </required_header>
  <id_info>
    <org_study_id>NEU007/1</org_study_id>
    <nct_id>NCT04440709</nct_id>
  </id_info>
  <brief_title>Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks</brief_title>
  <official_title>Restoration of Bimanual Activities of Daily Living Using a Brain/Neural Hand Exoskeleton (B/NHE) in Hand Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Reutlingen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hochschule der Medien</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Stuttgart</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      This study investigates whether spinal cord injury and stroke survivors (n=10) are able to&#xD;
      operate a brain/neural hand exoskeleton (B/NHE) based on electroencephalography (EEG) and&#xD;
      electrooculography (EOG) for restoration of bimanual activities of daily living (ADLs). To&#xD;
      assess bimanual ADLs, the Berlin Bimanual Task Assessment (BEBITA) will be applied.&#xD;
      Improvements in BEBITA will be evaluated with and without B/NHE use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Berlin Bimanual Task Assessment (BEBITA) score</measure>
    <time_frame>Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Brain/neural hand exoskeleton (B/NHE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Brain/neural hand exoskeleton (B/NHE)</intervention_name>
    <description>The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions</description>
    <arm_group_label>Brain/neural hand exoskeleton (B/NHE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Stroke):&#xD;
&#xD;
          -  single ischemic or hemorrhagic insult with subcortical lesion (medullary canal,&#xD;
             internal capsula, pedunculi cerebri)&#xD;
&#xD;
          -  interval since stroke at least 6 months&#xD;
&#xD;
          -  substantial motor deficit with:&#xD;
&#xD;
          -  Medical Research Council (MRC) -score of less than 2 out of 6 possible points (0=no&#xD;
             activity; 1=visible contraction without motor effect; 2=movements with elimination of&#xD;
             gravity; 3=movements against gravity; 4=movements against weak resistance; 5=normal&#xD;
             force)&#xD;
&#xD;
          -  Fugl-Meyer Test (upper extremity) of less than 31 points, &quot;no to little mobility&quot;&#xD;
&#xD;
        Inclusion Criteria (Spinal Cord Injury):&#xD;
&#xD;
          -  cervical spinal cord injury, height C5-C6&#xD;
&#xD;
          -  interval after spinal cord injury at least 6 months&#xD;
&#xD;
          -  substantial motor deficit with American Spinal Cord Association (ASIA) -Classification&#xD;
             B or C (A=no muscle function/sensitivity below the spinal cord injury; B=no muscle&#xD;
             function, limited sensitivity present; C=low non-relevant muscle function, sensitivity&#xD;
             present; D=functionally relevant muscle functions present; E=fully preserved or&#xD;
             restored functions)&#xD;
&#xD;
        Exclusion Criteria (Stroke and Spinal Cord Injury):&#xD;
&#xD;
          -  Alcohol or drug problem (regular consumption of more than 2 alcoholic beverages per&#xD;
             day, or taking illegal drugs)&#xD;
&#xD;
          -  currently undergoing neurological or psychiatric treatment based on a secondary&#xD;
             diagnosis&#xD;
&#xD;
          -  Severe and uncontrollable medical problems:&#xD;
&#xD;
          -  Non-adjusted malignant high blood pressure, World Health Organization (WHO)&#xD;
             Hypertension Grade II&#xD;
&#xD;
          -  non-adjustable diabetes mellitus, HbA1c &gt; 58 mmol/mol&#xD;
&#xD;
          -  renal failure, from KDIGO glomerular filtration rate (GFR) category G3b (moderate to&#xD;
             severe impairment)&#xD;
&#xD;
          -  Liver failure, Child-Pugh stages B and C&#xD;
&#xD;
          -  Heart failure New York Heart Association (NYHA) grade III-IV&#xD;
&#xD;
          -  malignant tumor disease&#xD;
&#xD;
          -  severe arrhythmia in need of treatment&#xD;
&#xD;
          -  severe oedemas&#xD;
&#xD;
          -  severe arthritis&#xD;
&#xD;
          -  serious cognitive impairment (minimum status below 23 points)&#xD;
&#xD;
          -  Severe spasticity (Ashworth grade ≥ 4)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Bilateral motor deficit (in stroke patients)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Surjo R. Soekadar, MD</last_name>
    <phone>+49-163-1644889</phone>
    <email>surjo.soekadar@uni-tuebingen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <state>BW</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Surjo R. Soekadar, MD</last_name>
      <phone>+49-163-1644889</phone>
      <email>surjo.soekadar@uni-tuebingen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Charité - University Medicine Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Surjo R Soekadar, MD</last_name>
      <phone>+49 30 450 528 153</phone>
      <email>surjo.soekadar@charite.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</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/NCT04440709
org study id: NEU007/1
nct id: NCT04440709
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study investigates whether spinal cord injury and stroke survivors (n=10) are able to
      operate a brain/neural hand exoskeleton (B/NHE) based on electroencephalography (EEG) and
      electrooculography (EOG) for restoration of bimanual activities of daily living (ADLs). To
      assess bimanual ADLs, the Berlin Bimanual Task Assessment (BEBITA) will be applied.
      Improvements in BEBITA will be evaluated with and without B/NHE use.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Berlin Bimanual Task Assessment (BEBITA) score
time frame: Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.
arm group label: Brain/neural hand exoskeleton (B/NHE)
arm group type: Experimental
intervention type: Device
intervention name: Brain/neural hand exoskeleton (B/NHE)
description: The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions
arm group label: Brain/neural hand exoskeleton (B/NHE)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 68 Years
healthy volunteers: No
last name: Surjo R. Soekadar, MD
phone: +49-163-1644889
email: surjo.soekadar@uni-tuebingen.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Spinal Cord Injuries