xml: <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/NCT06029062</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-22-0046 (Experiment 1)</org_study_id>
      <nct_id>NCT06029062</nct_id>
    </id_info>
    <brief_title>tACS for Sensory Motor Recovery After Stroke</brief_title>
    <official_title>tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</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_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall goal is to investigate the effectiveness of a novel intervention - transcranial&#xD;
        alternating current stimulation (tACS) for motor recovery in stroke survivors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2027</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Block and Box Test (BBT) of Motor functional test</measure>
      <time_frame>Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured.</time_frame>
      <description>The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick and simple test used with a wide range of populations, including clients with stroke.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EEG alpha band and Beta band</measure>
      <time_frame>Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured.</time_frame>
      <description>Electroencephalography (EEG) is valuable to infer and evaluate the neural interaction. Components of the alpha and beta frequency bands like the sensorimotor rhythm originated from the primary motor cortex and related brain areas reflect human movement. The power of 8-13 Hz alpha and 14-30 Hz beta frequency bands will be used for the classification.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Motor Recovery</condition>
    <arm_group>
      <arm_group_label>tACS Sham, tACS 10Hz, tACS 20Hz</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.&#xD;
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.&#xD;
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.&#xD;
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.&#xD;
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.&#xD;
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.&#xD;
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tACS Sham</intervention_name>
      <description>Sham tACS will applied to the brain through the scalp for 20 minutes.</description>
      <arm_group_label>HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham</arm_group_label>
      <arm_group_label>HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham</arm_group_label>
      <arm_group_label>tACS Sham, tACS 10Hz, tACS 20Hz</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tACS 10Hz</intervention_name>
      <description>10Hz tACS will applied to the brain through the scalp for 20 minutes.</description>
      <arm_group_label>HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham</arm_group_label>
      <arm_group_label>HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham</arm_group_label>
      <arm_group_label>tACS Sham, tACS 10Hz, tACS 20Hz</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tACS 20Hz</intervention_name>
      <description>20Hz tACS will applied to the brain through the scalp for 20 minutes.</description>
      <arm_group_label>HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham</arm_group_label>
      <arm_group_label>HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham</arm_group_label>
      <arm_group_label>tACS Sham, tACS 10Hz, tACS 20Hz</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion/exclusion criteria for stroke subjects&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Age between 18~75 years old&#xD;
  &#xD;
            2. ≥ 6 months post stroke, medically stable;&#xD;
  &#xD;
            3. Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume&#xD;
               (large or small) of stroke);&#xD;
  &#xD;
            4. Visible finger flexor activation/movement&#xD;
  &#xD;
            5. The ability to give consent&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Patients with visual deficit/neglect; hearing or cognitive impairment;&#xD;
  &#xD;
            2. Patients that are currently adjusting tone alternating medications (e.g., baclofen),&#xD;
               or&#xD;
  &#xD;
            3. Patients received botulinum toxin injection to the arm/fingers &lt;4 months, or phenol&#xD;
               injections &lt;2 years;&#xD;
  &#xD;
            4. Patients with pacemaker, metal implants or supplemental oxygen;&#xD;
  &#xD;
            5. Patients who have musculoskeletal disorders, including pain in the affected side&#xD;
  &#xD;
            6. Women who are pregnant.&#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>Sheng Li, MD, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sheng Li, MD, Ph.D</last_name>
      <phone>(713) 797-7125</phone>
      <email>sheng.li@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shengai Li, MS</last_name>
      <phone>713-797-7561</phone>
      <email>shengai.li@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sheng Li, MD, PhD</last_name>
        <phone>713-797-7125</phone>
        <email>sheng.li@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Shengai Li, MS</last_name>
        <phone>713-797-7561</phone>
        <email>shengai.li@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Sheng Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>tACS</keyword>
    <keyword>Motor recovery</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029062
  org study id: HSC-MS-22-0046 (Experiment 1)
  nct id: NCT06029062
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The overall goal is to investigate the effectiveness of a novel intervention - transcranial
        alternating current stimulation (tACS) for motor recovery in stroke survivors.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Block and Box Test (BBT) of Motor functional test
  time frame: Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured.
  description: The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick and simple test used with a wide range of populations, including clients with stroke.
  measure: EEG alpha band and Beta band
  time frame: Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured.
  description: Electroencephalography (EEG) is valuable to infer and evaluate the neural interaction. Components of the alpha and beta frequency bands like the sensorimotor rhythm originated from the primary motor cortex and related brain areas reflect human movement. The power of 8-13 Hz alpha and 14-30 Hz beta frequency bands will be used for the classification.
  arm group label: tACS Sham, tACS 10Hz, tACS 20Hz
  arm group type: Experimental
  description: tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  arm group label: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham
  arm group type: Experimental
  description: tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  arm group label: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham
  arm group type: Experimental
  description: tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  intervention type: Device
  intervention name: tACS Sham
  description: Sham tACS will applied to the brain through the scalp for 20 minutes.
  arm group label: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham
  arm group label: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham
  arm group label: tACS Sham, tACS 10Hz, tACS 20Hz
  intervention type: Device
  intervention name: tACS 10Hz
  description: 10Hz tACS will applied to the brain through the scalp for 20 minutes.
  arm group label: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham
  arm group label: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham
  arm group label: tACS Sham, tACS 10Hz, tACS 20Hz
  intervention type: Device
  intervention name: tACS 20Hz
  description: 20Hz tACS will applied to the brain through the scalp for 20 minutes.
  arm group label: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham
  arm group label: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham
  arm group label: tACS Sham, tACS 10Hz, tACS 20Hz
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Sheng Li, MD, Ph.D
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Sheng Li, MD, Ph.D
  phone: (713) 797-7125
  email: sheng.li@uth.tmc.edu
  last name: Shengai Li, MS
  phone: 713-797-7561
  email: shengai.li@uth.tmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Sheng Li
  investigator title: Professor
  sharing ipd: No