<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/NCT04477330</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0502</org_study_id>
    <nct_id>NCT04477330</nct_id>
  </id_info>
  <brief_title>Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal</brief_title>
  <official_title>Cortical Priming to Optimize Gait Rehabilitation: Renewal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      Achieving functional ambulation post stroke continues to be a challenge for stroke survivors,&#xD;
      clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical&#xD;
      priming using brain stimulation has emerged as a promising adjuvant to conventional&#xD;
      rehabilitation. This project focuses on the development of a long term gait rehabilitation&#xD;
      protocol using brain stimulation to improve walking outcomes in people with stroke. The&#xD;
      project will also aim to understand the neural mechanisms that are associated with response&#xD;
      to the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Walking speed with 10 meter walk test</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up</time_frame>
    <description>Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking spatiotemporal characteristics with GAITRite walkway</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up</time_frame>
    <description>Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor impairment with Fugl Meyer Lower Extremity Scale</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up</time_frame>
    <description>Lower extremity impairment will be measured using the Fugl Meyer Lower Extremity Scale (FMLE), a series of tests of movement, reflex activity, coordination/speed, sensation, and range of motion. The maximum score is 34 and a high score indicates less impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking endurance with 6-minute walk test</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up</time_frame>
    <description>Walking endurance will be measured using the 6-Minute Walk test. Participants will walk as far as possible within 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle range of motion</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up</time_frame>
    <description>Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle motor control</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up</time_frame>
    <description>The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance with mini Balance Evaluations Systems Test (miniBESTest)</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up.</time_frame>
    <description>Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic capacity</measure>
    <time_frame>Change from baseline to immediately after training.</time_frame>
    <description>Cardiopulmonary exercise tests will be performed on a motorized treadmill following an individualized protocol using standard procedures. Measures relating to peak oxygen consumption (VO2 max) will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life with EuroQol-5D (EQ-5D)</measure>
    <time_frame>Change from baseline to immediately after training.</time_frame>
    <description>Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability with Modified Rankin Scale</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up.</time_frame>
    <description>Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community ambulation with wearable sensors</measure>
    <time_frame>Change from baseline to immediately after training.</time_frame>
    <description>Daily ambulation will be assessed using an accelerometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum brain derived neurotrophic growth factor (BDNF)</measure>
    <time_frame>Change from baseline to immediately after training.</time_frame>
    <description>5 ml of blood will be collected from a vein in the participants' arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corticomotor excitability using transcranial magnetic stimulation</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up.</time_frame>
    <description>Corticomotor excitability of the paretic and non-paretic lower limb muscles such as the tibialis anterior and soleus muscle representations will be measured with single pulse transcranial magnetic stimulation (TMS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function using Mini Mental Screening Examination</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up.</time_frame>
    <description>30-point questionnaire used to capture orientation, attention, memory and language.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression using Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up.</time_frame>
    <description>The 9-point questionnaire is used to measure degree of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>Change from baseline to immediately after training and baseline to 3 months follow up.</time_frame>
    <description>The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Priming+HIISTT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham+HIISTT</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS before high intensity interval speed based treadmill training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial direct current stimulation (tDCS)</intervention_name>
    <description>1 mA tDCS</description>
    <arm_group_label>Priming+HIISTT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ankle motor training</intervention_name>
    <description>Visuomotor target tracking task</description>
    <arm_group_label>Priming+HIISTT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity interval speed based treadmill training (HIISTT)</intervention_name>
    <description>Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.</description>
    <arm_group_label>Priming+HIISTT</arm_group_label>
    <arm_group_label>Sham+HIISTT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years&#xD;
&#xD;
          -  First ever monohemispheric stroke &gt; 3 months since onset&#xD;
&#xD;
          -  Residual hemiparetic gait deficits (e.g. abnormal gait pattern)&#xD;
&#xD;
          -  Able to walk for 5 minutes at self-paced speed. Handheld assistive device is&#xD;
             acceptable.&#xD;
&#xD;
          -  Walking speed lesser than 1.2 m/s&#xD;
&#xD;
          -  Lower limb Fugl-Meyer Motor score between 15-30&#xD;
&#xD;
          -  At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General exclusion criteria&#xD;
&#xD;
               -  Severe osteoporosis&#xD;
&#xD;
               -  Contracture-limiting range of motion of lower limb&#xD;
&#xD;
               -  Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle&#xD;
                  tone through ankle range of motion)&#xD;
&#xD;
               -  Uncontrolled anti-spasticity medications during the study period&#xD;
&#xD;
               -  Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb&#xD;
&#xD;
               -  Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled&#xD;
                  hypertension or diabetes, chronic emphysema)&#xD;
&#xD;
               -  Unhealed decubiti, persistent infection&#xD;
&#xD;
               -  Significant cognitive or communication impairment (Mini-Mental State Examination&#xD;
                  (MMSE)&lt;21), which could impede the understanding of the purpose of procedures of&#xD;
                  the study or prevent the patient from performing the ankle-tracking task.&#xD;
&#xD;
               -  Lesions involving the brainstem and cerebellum&#xD;
&#xD;
               -  Failure to pass the graded exercise stress test&#xD;
&#xD;
        TMS exclusion criteria&#xD;
&#xD;
          -  Implanted cardiac pacemaker&#xD;
&#xD;
          -  Metal implants in the head or face&#xD;
&#xD;
          -  Unexplained, recurring headaches&#xD;
&#xD;
          -  History of seizures or epilepsy&#xD;
&#xD;
          -  Currently under medication that could increase motor excitability and lower seizure&#xD;
             threshold&#xD;
&#xD;
          -  Skull abnormalities or fractures&#xD;
&#xD;
          -  Concussion within the last 6 months&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
        tDCS exclusion criteria&#xD;
&#xD;
          -  Skin hypersensitivity&#xD;
&#xD;
          -  History of contact dermatitits&#xD;
&#xD;
          -  History of allodynia and/or hyperalgesia&#xD;
&#xD;
          -  Any other skin or scalp condition that could be aggravated by tDCS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangeetha Madhavan</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sangeetha Madhavan</last_name>
    <phone>3123552517</phone>
    <email>smadhava@uic.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Physical Therapy</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sangeetha Madhavan</last_name>
      <email>brainlab@uic.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Sangeetha Madhavan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>tDCS</keyword>
  <keyword>Walking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04477330
org study id: 2020-0502
nct id: NCT04477330
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors,
      clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical
      priming using brain stimulation has emerged as a promising adjuvant to conventional
      rehabilitation. This project focuses on the development of a long term gait rehabilitation
      protocol using brain stimulation to improve walking outcomes in people with stroke. The
      project will also aim to understand the neural mechanisms that are associated with response
      to the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Walking speed with 10 meter walk test
time frame: Change from baseline to immediately after training and baseline to 3 months follow up
description: Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).
measure: Walking spatiotemporal characteristics with GAITRite walkway
time frame: Change from baseline to immediately after training and baseline to 3 months follow up
description: Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).
measure: Motor impairment with Fugl Meyer Lower Extremity Scale
time frame: Change from baseline to immediately after training and baseline to 3 months follow up
description: Lower extremity impairment will be measured using the Fugl Meyer Lower Extremity Scale (FMLE), a series of tests of movement, reflex activity, coordination/speed, sensation, and range of motion. The maximum score is 34 and a high score indicates less impairment
measure: Walking endurance with 6-minute walk test
time frame: Change from baseline to immediately after training and baseline to 3 months follow up
description: Walking endurance will be measured using the 6-Minute Walk test. Participants will walk as far as possible within 6 minutes.
measure: Ankle range of motion
time frame: Change from baseline to immediately after training and baseline to 3 months follow up
description: Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.
measure: Ankle motor control
time frame: Change from baseline to immediately after training and baseline to 3 months follow up
description: The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.
measure: Balance with mini Balance Evaluations Systems Test (miniBESTest)
time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
description: Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.
measure: Aerobic capacity
time frame: Change from baseline to immediately after training.
description: Cardiopulmonary exercise tests will be performed on a motorized treadmill following an individualized protocol using standard procedures. Measures relating to peak oxygen consumption (VO2 max) will be calculated.
measure: Quality of Life with EuroQol-5D (EQ-5D)
time frame: Change from baseline to immediately after training.
description: Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.
measure: Disability with Modified Rankin Scale
time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
description: Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.
measure: Community ambulation with wearable sensors
time frame: Change from baseline to immediately after training.
description: Daily ambulation will be assessed using an accelerometer.
measure: Serum brain derived neurotrophic growth factor (BDNF)
time frame: Change from baseline to immediately after training.
description: 5 ml of blood will be collected from a vein in the participants' arms
measure: Corticomotor excitability using transcranial magnetic stimulation
time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
description: Corticomotor excitability of the paretic and non-paretic lower limb muscles such as the tibialis anterior and soleus muscle representations will be measured with single pulse transcranial magnetic stimulation (TMS).
measure: Cognitive function using Mini Mental Screening Examination
time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
description: 30-point questionnaire used to capture orientation, attention, memory and language.
measure: Depression using Patient Health Questionnaire-9 (PHQ-9)
time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
description: The 9-point questionnaire is used to measure degree of depression.
measure: Modified Ashworth Scale
time frame: Change from baseline to immediately after training and baseline to 3 months follow up.
description: The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,
arm group label: Priming+HIISTT
arm group type: Experimental
description: Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
arm group label: Sham+HIISTT
arm group type: Sham Comparator
description: Sham tDCS before high intensity interval speed based treadmill training
intervention type: Other
intervention name: Transcranial direct current stimulation (tDCS)
description: 1 mA tDCS
arm group label: Priming+HIISTT
intervention type: Other
intervention name: Ankle motor training
description: Visuomotor target tracking task
arm group label: Priming+HIISTT
intervention type: Behavioral
intervention name: High intensity interval speed based treadmill training (HIISTT)
description: Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
arm group label: Priming+HIISTT
arm group label: Sham+HIISTT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sangeetha Madhavan
role: Principal Investigator
affiliation: University of Illinois at Chicago
last name: Sangeetha Madhavan
phone: 3123552517
email: smadhava@uic.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Sangeetha Madhavan
investigator title: Professor
mesh term: Stroke
sharing ipd: Undecided