<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/NCT04502290</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19070157</org_study_id>
    <nct_id>NCT04502290</nct_id>
  </id_info>
  <brief_title>Synchronized Brain and Hand Stimulation After Stroke</brief_title>
  <official_title>Synchronized Brain and Hand Stimulation to Improve Hand Function After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amit Sethi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among the 795,000 individuals who sustain a stroke annually in the United States, 65%&#xD;
      continue to experience moderate-to-severe impairments in one hand six months or more, which&#xD;
      limits their ability to perform daily tasks. Currently there is dearth of understanding of&#xD;
      the mechanisms of motor recovery after stroke. Understanding the mechanisms can potentially&#xD;
      lead to the development of interventions to improve motor performance after stroke. The&#xD;
      proposed study will examine how synchronously pairing brain and hand stimulation repeatedly&#xD;
      affects the plasticity of the brain and motor performance after stroke. The knowledge gained&#xD;
      from this study can be useful to develop interventions to improve hand movement after&#xD;
      moderate-severe stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Box and block test</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor evoked potential</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand force</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>We will measure force production of the wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate force output over the central 5 second segment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Stroke</condition>
  <condition>Upper Extremity Paresis</condition>
  <arm_group>
    <arm_group_label>Combined non-invasive brain and Functional Electrical Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Combined Non-invasive brain stimulation and functional electrical hand stimulation</intervention_name>
    <description>Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand</description>
    <arm_group_label>Combined non-invasive brain and Functional Electrical Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female (either right or left handed) with unilateral hemiparesis after stroke;&#xD;
&#xD;
          2. Stroke onset of at least six months prior to the time of participation;&#xD;
&#xD;
          3. Ability to elicit motor evoked potential in the Extensor digitorum communis (EDC)&#xD;
             muscle&#xD;
&#xD;
          4. Ability to grasp, as indicated by a score of at least 1 (out of 2) on the finger mass&#xD;
             flexion and cylindrical grasp items of Upper Extremity Fugl-Meyer scale&#xD;
&#xD;
          5. age between 18-80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of severe aphasia , measured by cognitive and/or language impairments that&#xD;
             preclude the ability to follow simple instructions;&#xD;
&#xD;
          2. Excessive spasticity of wrist and finger muscles, defined as a Modified Ashworth Score&#xD;
             more than or equal to 3, which may limit the ability to open the hand/fingers;&#xD;
&#xD;
          3. Diagnosis of neurological disorders other than stroke, which may confound the results;&#xD;
&#xD;
          4. Has touch and proprioceptive sensory deficits determined via a score of 0 on the&#xD;
             position sense section (section H) of the Fugl Meyer Upper Extremity assessment&#xD;
             proprioception, which may limit the ability to report excessive amount of tingling due&#xD;
             to hand stimulation&#xD;
&#xD;
          5. History of seizure or epilepsy as the effects of TMS are not tested in individuals&#xD;
             with seizures or epilepsy;&#xD;
&#xD;
          6. Orthopaedic/musculoskeletal conditions (eg, arthritis) affecting the upper extremity,&#xD;
             which may limit the ability to move the affected hand&#xD;
&#xD;
          7. Presence of metallic implants in the head or neck for TMS;&#xD;
&#xD;
          8. Currently or planning to become pregnant, as the effects of TMS are not tested not&#xD;
             pregnant women;&#xD;
&#xD;
          9. Difficulty maintaining alertness or remaining still for MRI;&#xD;
&#xD;
         10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators&#xD;
             (for MRI);&#xD;
&#xD;
         11. Bodyweight &gt; 300 lbs due to MRI scanner dimensions&#xD;
&#xD;
         12. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical&#xD;
             Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic&#xD;
             medication, which may confound the results&#xD;
&#xD;
         13. Cognitive impairments, defined as a score of &lt; 23 on the Mini Mental Status&#xD;
             Examination, which may limit the ability to follow the commands in the study&#xD;
&#xD;
         14. Excessive pain &gt; equal to 5 on Visual Analog Scale in the more-affected upper&#xD;
             extremity, which may limit the ability to participate in the study&#xD;
&#xD;
         15. History of schizophrenia, Bipolar disorder (type I or II) [Answer yes to questions 16&#xD;
             and items of the (hypo) maniac module of the The Mini International Neuropsychiatric&#xD;
             Interview], current moderate, severe depression (Scores of &gt;10 on Patient Health&#xD;
             Questionnaire-9) and other neurological or medical conditions that could confound&#xD;
             results.&#xD;
&#xD;
         16. Life expectancy less than the duration of the study&#xD;
&#xD;
         17. Hemispatial neglect, which may limit the ability to pay attention to the affected hand&#xD;
&#xD;
         18. Participating in concurrent therapy, which may confound the results&#xD;
&#xD;
         19. We will exclude children because although stroke may occur in children, the protocol&#xD;
             is addressing stoke in adults and the devices are not approved for use in children&#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>Amit Sethi</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPitt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amit Sethi</last_name>
    <phone>4123836619</phone>
    <email>asethi@pitt.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Neuromotor Recovery and Rehabilitation Lab</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amit Sethi</last_name>
      <phone>412-383-6619</phone>
      <email>asethi@pitt.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Amit Sethi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04502290
org study id: STUDY19070157
nct id: NCT04502290
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Among the 795,000 individuals who sustain a stroke annually in the United States, 65%
      continue to experience moderate-to-severe impairments in one hand six months or more, which
      limits their ability to perform daily tasks. Currently there is dearth of understanding of
      the mechanisms of motor recovery after stroke. Understanding the mechanisms can potentially
      lead to the development of interventions to improve motor performance after stroke. The
      proposed study will examine how synchronously pairing brain and hand stimulation repeatedly
      affects the plasticity of the brain and motor performance after stroke. The knowledge gained
      from this study can be useful to develop interventions to improve hand movement after
      moderate-severe stroke.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Box and block test
time frame: Baseline to 6 weeks
description: The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when
measure: Motor evoked potential
time frame: Baseline to 6 weeks
description: Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK).
measure: Hand force
time frame: Baseline to 6 weeks
description: We will measure force production of the wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate force output over the central 5 second segment.
arm group label: Combined non-invasive brain and Functional Electrical Stimulation
arm group type: Experimental
description: In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
intervention type: Device
intervention name: Combined Non-invasive brain stimulation and functional electrical hand stimulation
description: Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand
arm group label: Combined non-invasive brain and Functional Electrical Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Amit Sethi
role: Principal Investigator
affiliation: UPitt
last name: Amit Sethi
phone: 4123836619
email: asethi@pitt.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Amit Sethi
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Paresis
sharing ipd: No