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/NCT05963958</url>
    </required_header>
    <id_info>
      <org_study_id>Delirium/HD-tDCS</org_study_id>
      <nct_id>NCT05963958</nct_id>
    </id_info>
    <brief_title>HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19</brief_title>
    <acronym>COVID-19</acronym>
    <official_title>HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suellen Andrade</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>City University of New York</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Federal University of Paraíba</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or&#xD;
        sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due&#xD;
        to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS&#xD;
        combined with concomitant dexmedetomidine would reduce delirium rates.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 14, 2021</start_date>
    <completion_date type="Actual">January 30, 2023</completion_date>
    <primary_completion_date type="Actual">December 2, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Applicators were blinded to who was receiving active stimulation and who was receiving placebo. The study drug was prepared by the nurses or nursing technicians, or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Delirium Severity</measure>
      <time_frame>28 days</time_frame>
      <description>delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>length of stay in the ICU and hospital stay</measure>
      <time_frame>28 days</time_frame>
      <description>defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of hypotension requiring any vasopressor administration</measure>
      <time_frame>28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein levels</measure>
      <time_frame>28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ventilator-free days during the first 28 days</measure>
      <time_frame>28 days</time_frame>
      <description>defined as the number of days free from mechanical ventilation for at least 48 consecutive hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory analisys</measure>
      <time_frame>28 days</time_frame>
      <description>Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>COVID-19</condition>
    <condition>Delirium</condition>
    <condition>Critical Illness</condition>
    <arm_group>
      <arm_group_label>Active HD-tDCS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham HD-tDCS</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Active HD-tDCS</intervention_name>
      <description>Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19</description>
      <arm_group_label>Active HD-tDCS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Sham HD-tDCS</intervention_name>
      <description>Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19</description>
      <arm_group_label>Sham HD-tDCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥18 years,&#xD;
  &#xD;
            -  confirmed clinical diagnosis for SARS-CoV-2,&#xD;
  &#xD;
            -  delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  severe psychiatric illness that is not well controlled;&#xD;
  &#xD;
            -  pregnancy or active lactation,&#xD;
  &#xD;
            -  refusal of consent&#xD;
  &#xD;
            -  contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy,&#xD;
               dermatitis at the site of stimulation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Federal University of Paraiba</name>
        <address>
          <city>João Pessoa</city>
          <state>Paraiba</state>
          <zip>51051900</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 1, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Federal University of Paraíba</investigator_affiliation>
      <investigator_full_name>Suellen Andrade</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <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/NCT05963958
  org study id: Delirium/HD-tDCS
  nct id: NCT05963958
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or
        sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due
        to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS
        combined with concomitant dexmedetomidine would reduce delirium rates.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Applicators were blinded to who was receiving active stimulation and who was receiving placebo. The study drug was prepared by the nurses or nursing technicians, or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation.
  measure: Delirium Severity
  time frame: 28 days
  description: delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.
  measure: length of stay in the ICU and hospital stay
  time frame: 28 days
  description: defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge
  measure: Occurrence of hypotension requiring any vasopressor administration
  time frame: 28 days
  measure: C-reactive protein levels
  time frame: 28 days
  measure: ventilator-free days during the first 28 days
  time frame: 28 days
  description: defined as the number of days free from mechanical ventilation for at least 48 consecutive hours
  measure: Exploratory analisys
  time frame: 28 days
  description: Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis
  arm group label: Active HD-tDCS
  arm group type: Experimental
  description: HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).
  arm group label: Sham HD-tDCS
  arm group type: Placebo Comparator
  description: HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).
  intervention type: Combination Product
  intervention name: Active HD-tDCS
  description: Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
  arm group label: Active HD-tDCS
  intervention type: Combination Product
  intervention name: Sham HD-tDCS
  description: Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
  arm group label: Sham HD-tDCS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  facility: 
  country: Brazil
  responsible party type: Sponsor-Investigator
  investigator affiliation: Federal University of Paraíba
  investigator full name: Suellen Andrade
  investigator title: Principal Investigator
  mesh term: COVID-19
  mesh term: Delirium
  mesh term: Critical Illness
  sharing ipd: No