<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/NCT03230695</url>
  </required_header>
  <id_info>
    <org_study_id>RCT2129001</org_study_id>
    <nct_id>NCT03230695</nct_id>
  </id_info>
  <brief_title>Robotic Therapy and Brain Stimulation in the Early Phase After Stroke</brief_title>
  <official_title>Effects of Robotic Therapy and Transcranial Direct Current Stimulation on Motor Performance of the Paretic Upper Limb in the Early Phase After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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>
      Stroke is the second cause of death worldwide and the majority of the survivors remain with&#xD;
      motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as&#xD;
      a potential intervention to enhance effects of other rehabilitation strategies on improvement&#xD;
      of motor performance of the paretic upper limb. In this proof-of-concept study we will&#xD;
      evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere&#xD;
      associated with robotic therapy on improvement of motor performance of the paretic upper limb&#xD;
      in the early phase post-stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main goal of this study is to test the proof of concept of benefits of inhibition of the&#xD;
      motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics&#xD;
      of motor performance, in patients with upper limb paresis in the early phase post-stroke. For&#xD;
      this purpose, patients will be randomized to receive real or sham transcranial direct current&#xD;
      stimulation before a session of robotic therapy. Data will be collected by kinematic&#xD;
      assessment performed automatically by the robot at baseline, immediately after and 24h after&#xD;
      the intervention.&#xD;
&#xD;
      The working hypothesis is that one session of upper limb motor training will lead to&#xD;
      improvement of performance in metrics of kinematics, and this improvement will be maintained&#xD;
      up to 24h after the end of the training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Movement Smoothness</measure>
    <time_frame>Kinematic assessment at baseline, immediately after intervention; and 24h after.</time_frame>
    <description>The speed shape, calculated as mean speed divided by peak speed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of peaks of the movement</measure>
    <time_frame>kinematic assessment at baseline, immediately after intervention; and 24h after.</time_frame>
    <description>Number of peaks of the movement is calculated as the negative of the number of peaks in the speed profile.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jerk metric of the movement</measure>
    <time_frame>kinematic assessment at baseline, immediately after intervention; and 24h after</time_frame>
    <description>Jerk metric of the movement is calculated by dividing the negative mean jerk magnitude by the peak speed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Active stimulation + robotic therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.&#xD;
Number of interventions sessions: 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation + robotic therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.&#xD;
Number of interventions sessions: 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic Therapy</intervention_name>
    <description>Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.</description>
    <arm_group_label>Active stimulation + robotic therapy</arm_group_label>
    <arm_group_label>Sham stimulation + robotic therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active stimulation</intervention_name>
    <description>Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).</description>
    <arm_group_label>Active stimulation + robotic therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham stimulation</intervention_name>
    <description>In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.</description>
    <arm_group_label>Sham stimulation + robotic therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed&#xD;
        tomography or magnetic resonance imaging.&#xD;
&#xD;
        Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research&#xD;
        Council Scale, for at lest one the following movements: elbow extension, shoulder flexion,&#xD;
        or shoulder extension.&#xD;
&#xD;
        Ability to provide written informed consent.&#xD;
&#xD;
        Ability to comply with the schedule of interventions and evaluations in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of &gt; 3 in the&#xD;
        Modified Ashworth Spasticity Scale.&#xD;
&#xD;
        No active shoulder and elbow movements&#xD;
&#xD;
        Uncontrolled medical problems such as end-stage cancer or renal disease&#xD;
&#xD;
        Pregnancy&#xD;
&#xD;
        Potential contraindications to transcranial direct current stimulation: history of&#xD;
        seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery,&#xD;
        use of drugs that interfere on cortical excitability (such as antiepileptic drugs,&#xD;
        benzodiazepines)&#xD;
&#xD;
        Other neurological disorders such as Parkinson's disease&#xD;
&#xD;
        Psychiatric illness&#xD;
&#xD;
        Aphasia or severe cognitive deficits that compromise comprehension of the experimental&#xD;
        protocol or ability to provide consent.&#xD;
&#xD;
        Hemineglect&#xD;
&#xD;
        Cerebellar lesions or on cerebellar pathways&#xD;
&#xD;
        Contact precautions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adriana B Conforto, D, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Suzana Bleckmann Reis</name>
      <address>
        <city>São Paulo</city>
        <zip>05403900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>robotic therapy</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03230695
org study id: RCT2129001
nct id: NCT03230695
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Stroke is the second cause of death worldwide and the majority of the survivors remain with
      motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as
      a potential intervention to enhance effects of other rehabilitation strategies on improvement
      of motor performance of the paretic upper limb. In this proof-of-concept study we will
      evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere
      associated with robotic therapy on improvement of motor performance of the paretic upper limb
      in the early phase post-stroke.
The main goal of this study is to test the proof of concept of benefits of inhibition of the
      motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics
      of motor performance, in patients with upper limb paresis in the early phase post-stroke. For
      this purpose, patients will be randomized to receive real or sham transcranial direct current
      stimulation before a session of robotic therapy. Data will be collected by kinematic
      assessment performed automatically by the robot at baseline, immediately after and 24h after
      the intervention.

      The working hypothesis is that one session of upper limb motor training will lead to
      improvement of performance in metrics of kinematics, and this improvement will be maintained
      up to 24h after the end of the training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Movement Smoothness
time frame: Kinematic assessment at baseline, immediately after intervention; and 24h after.
description: The speed shape, calculated as mean speed divided by peak speed.
measure: Number of peaks of the movement
time frame: kinematic assessment at baseline, immediately after intervention; and 24h after.
description: Number of peaks of the movement is calculated as the negative of the number of peaks in the speed profile.
measure: Jerk metric of the movement
time frame: kinematic assessment at baseline, immediately after intervention; and 24h after
description: Jerk metric of the movement is calculated by dividing the negative mean jerk magnitude by the peak speed.
arm group label: Active stimulation + robotic therapy
arm group type: Active Comparator
description: Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.
Number of interventions sessions: 1
arm group label: Sham stimulation + robotic therapy
arm group type: Sham Comparator
description: Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.
Number of interventions sessions: 1
intervention type: Device
intervention name: Robotic Therapy
description: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
arm group label: Active stimulation + robotic therapy
arm group label: Sham stimulation + robotic therapy
intervention type: Device
intervention name: Active stimulation
description: Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
arm group label: Active stimulation + robotic therapy
intervention type: Device
intervention name: Sham stimulation
description: In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.
arm group label: Sham stimulation + robotic therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Adriana B Conforto, D, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Stroke