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/NCT05965752</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00112477</org_study_id>
      <secondary_id>OTA-21-015G</secondary_id>
      <nct_id>NCT05965752</nct_id>
    </id_info>
    <brief_title>RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms</brief_title>
    <official_title>RECOVER-NEURO: A Platform Protocol for Evaluation of Interventions for Cognitive Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This platform protocol is designed to be flexible so that it is suitable for a wide range of&#xD;
        settings within health care systems, for remote settings, and in community settings where it&#xD;
        can be integrated into COVID-19 programs and subsequent treatment plans.&#xD;
  &#xD;
        This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform&#xD;
        trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The&#xD;
        hypothesis is that PASC-mediated declines in cognitive domains, such as executive function&#xD;
        and attention, may be improved by interventions that selectively focus on enhancing those&#xD;
        domains.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be randomized to one of the intervention appendices that are actively&#xD;
        enrolling at the time of randomization. Intervention appendices may be added or removed&#xD;
        according to adaptive design and/or emerging evidence. Various interventions will be studied.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <intervention_model_description>To achieve blinding and an equitable randomization probability, a two-step randomization process will be used. The study will employ a simple (unstratified) randomization scheme.&#xD;
  At the first stage, each participant will be assigned with equal probability to one of the intervention appendices for which the participant is eligible, after applying any intervention-specific safety exclusions. At the second stage, each participant will be assigned according to the specific appendix's randomization procedure. Participants will have an equal chance of being randomized into any of the intervention groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>Participants assigned to active comparator will be considered part of pooled analyses if the intervention was active at the time of the participant's enrollment and the participants were eligible to receive that intervention. This will result in approximately a 1:1 allocation ratio for any intervention to pooled control.&#xD;
  Sites will be informed to which intervention appendix participants are randomized, but, when applicable, not whether the participants are allocated to the active intervention arm or active comparator arm within that appendix. The participants and investigators will be blinded throughout the study, when possible.&#xD;
  If open intervention appendices do not have the ability to pool controls but have independent controls, at the second stage participants will be randomized in a 1:1 ratio to intervention vs active comparator inside the specific intervention appendix the participants were randomized to at the first stage of the randomization procedure.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Everyday Cognition 2 (ECog2)</measure>
      <time_frame>Baseline to End of Intervention (EOI) (Day 70)</time_frame>
      <description>Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in PROMIS-cognitive function - short form 8a (PROMIS-Cog) total score</measure>
      <time_frame>Baseline, EOI (Day 70), End of Study (EOS) (Day 160)</time_frame>
      <description>The PROMIS-Cog is the PROMIS short form for the cognitive function domain and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on an objective neurocognitive battery scores</measure>
      <time_frame>Baseline, EOI (Day 70), EOS (Day 160)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Everyday Cognition 2 (ECog2)</measure>
      <time_frame>Baseline, EOS (Day 160)</time_frame>
      <description>Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterize the intervention's safety as measured by the proportion of Serious Adverse Events</measure>
      <time_frame>Baseline to EOS (Day 160)</time_frame>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">315</enrollment>
    <condition>Long COVID</condition>
    <condition>Long Covid19</condition>
    <condition>Long Covid-19</condition>
    <arm_group>
      <arm_group_label>BrainHQ Active Comparator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>5 sessions/week at 30 min/session</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BrainHQ</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 sessions/week at 30 min/session</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BrainHQ + PASC CoRE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Brain HQ + tDCS-active</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2.0 mA stimulation delivered for 30 min during each BrainHQ session</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Brain HQ + tDCS-sham</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Inactive stimulation delivered for 30 min during each BrainHQ session</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>BrainHQ/Active Comparator Activity</intervention_name>
      <description>BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.</description>
      <arm_group_label>BrainHQ Active Comparator</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>BrainHQ</intervention_name>
      <description>BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.</description>
      <arm_group_label>Brain HQ + tDCS-active</arm_group_label>
      <arm_group_label>Brain HQ + tDCS-sham</arm_group_label>
      <arm_group_label>BrainHQ</arm_group_label>
      <arm_group_label>BrainHQ + PASC CoRE</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PASC CoRE</intervention_name>
      <description>Goal-oriented attentional self-regulation (GOALS) is a manualized, adaptable cognitive rehabilitation intervention with demonstrated efficacy in improving attention and executive functions, among other cognitive domains.</description>
      <arm_group_label>BrainHQ + PASC CoRE</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tDCS-active</intervention_name>
      <description>Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.&#xD;
  The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.</description>
      <arm_group_label>Brain HQ + tDCS-active</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tDCS-sham</intervention_name>
      <description>tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.</description>
      <arm_group_label>Brain HQ + tDCS-sham</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In order to be eligible to participate in this study, an individual must meet all of the&#xD;
          following criteria:&#xD;
  &#xD;
            1. ≥ 18 years of age at the time of enrollment&#xD;
  &#xD;
            2. PROMIS-Cog T-score &lt; 40&#xD;
  &#xD;
            3. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan&#xD;
               American Health Organization&#xD;
  &#xD;
               Suspected case of SARS-CoV-2 infection - three options, A through C:&#xD;
  &#xD;
               A. Met clinical OR epidemiological criteria:&#xD;
  &#xD;
               a. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute&#xD;
               onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general,&#xD;
               weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea,&#xD;
               anorexia; b. Epidemiological criteria: Contact of a probable or confirmed case or&#xD;
               linked to a COVID-19 cluster;&#xD;
  &#xD;
               B. Presented acute respiratory infection with history of fever or measured fever of ≥&#xD;
               38°C and cough, with onset within the last 10 days, and who requires hospitalization;&#xD;
               or&#xD;
  &#xD;
               C. Presented with no clinical signs or symptoms, NOR meeting epidemiologic criteria&#xD;
               with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic&#xD;
               Test.&#xD;
  &#xD;
               Probable case of SARS-CoV-2 infection, defined as having met clinical criteria above&#xD;
               AND was a contact of a probable or confirmed case or was linked to a COVID-19 cluster.&#xD;
  &#xD;
               Confirmed case of SARS-CoV-2 infection - two options, A through B:&#xD;
  &#xD;
               A. Presented with a positive nucleic acid amplification test, regardless of clinical&#xD;
               criteria OR epidemiological criteria; or&#xD;
  &#xD;
               B. Met clinical AND/OR epidemiological criteria (See suspected case A.a.), with a&#xD;
               positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.&#xD;
  &#xD;
               * Suspected and probable cases will only be allowed if they occurred before May 1,&#xD;
               2021, and will be limited to 10% of the study population. Otherwise, confirmed cases&#xD;
               are required.&#xD;
  &#xD;
            4. Cognitive dysfunction symptoms following a SARS-CoV-2 infection that have persisted&#xD;
               for at least 12 weeks and are still present at the time of consent&#xD;
  &#xD;
            5. Fluent in English or Spanish language&#xD;
  &#xD;
            6. Willing and able to provide informed consent, complete the intervention, complete the&#xD;
               intervention assessments, and return for all of the necessary follow-up visits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          An individual who meets any of the following criteria will be excluded from participation&#xD;
          in this study:&#xD;
  &#xD;
            1. Prior or active unstable or progressive major psychiatric or neurologic condition that&#xD;
               would not show improvement and could hide treatment effect and is not related to&#xD;
               SARS-CoV-2 infection, at the investigator's discretion, including, but not limited to,&#xD;
               the following examples:&#xD;
  &#xD;
               a. Progressive neurodegenerative disease, such as Alzheimer's disease, Parkinson's&#xD;
               disease, etc.&#xD;
  &#xD;
               b. Past traumatic brain injury occurrence still associated with active post-concussive&#xD;
               symptoms c. Uncontrolled seizure disorder, such as having at least one seizure in the&#xD;
               last year that is adjudicated by clinical judgement d. Post-stroke deficits that may&#xD;
               interfere with assessment, such as language or communication difficulties, aphasia,&#xD;
               etc.&#xD;
  &#xD;
               e. Formal thought disorders, such as schizophrenia, etc. f. Any neuropsychiatric or&#xD;
               neurologic disorder uncontrolled for the previous six months or that may interfere&#xD;
               with assessment, at discretion of the investigator&#xD;
  &#xD;
            2. Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome, not&#xD;
               related to SARS-CoV-2 infection&#xD;
  &#xD;
            3. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent&#xD;
  &#xD;
            4. Current use of symptomatic therapies including prescribed or illicit stimulants,&#xD;
               amantadine, N-methyl-D-aspartate receptor antagonists (e.g., memantine, dissociative&#xD;
               drugs)&#xD;
  &#xD;
            5. Current use of a stimulant for treating any PASC-related symptom&#xD;
  &#xD;
            6. Current diagnosis of alcohol and substance use disorders&#xD;
  &#xD;
               a. Prior use disorders acceptable if abstinence achieved and maintained for at least&#xD;
               12 months before study enrollment&#xD;
  &#xD;
            7. Insufficient visual, auditory, and motor function to participate in intervention and&#xD;
               assessments&#xD;
  &#xD;
            8. Known pregnancy&#xD;
  &#xD;
            9. Current or recent use (within the last 2 months) of intervention*&#xD;
  &#xD;
           10. Known allergy/sensitivity/hypersensitivity to components of the intervention or&#xD;
               comparator*&#xD;
  &#xD;
           11. Currently receiving/using intervention from another clinical trial, such as another&#xD;
               RECOVER trial&#xD;
  &#xD;
           12. Any condition that would make the participant, in the opinion of the investigator,&#xD;
               unsuitable for the study&#xD;
  &#xD;
                 1. The site investigator has the discretion to determine whether a participant is&#xD;
                    too cognitively impaired to participate and should instead be referred for&#xD;
                    clinical evaluation.&#xD;
  &#xD;
          Exclusions specific to intervention appendices are listed in each appendix.&#xD;
  &#xD;
          * Relevant if only one intervention appendix is open at the time of enrollment, though&#xD;
          exclusion may be qualified in the appendix. If multiple intervention appendices are open, a&#xD;
          participant may be excluded from any intervention appendix based on contraindications&#xD;
          listed in the intervention appendix, current use of intervention, or known&#xD;
          allergy/sensitivity/hypersensitivity and still remain eligible for the remaining&#xD;
          intervention appendices.&#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>Kanecia Zimmerman, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Daniel Laskowitz, MD MHS</last_name>
      <role>Study Chair</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Texas Health Science Center at San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>West Virginia Clinical and Translational Science Institute</name>
        <address>
          <city>Morgantown</city>
          <state>West Virginia</state>
          <zip>26506</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://recovercovid.org/</url>
      <description>Related Info</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PASC</keyword>
    <keyword>Cognitive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The investigators will share the summary of results on the study website: https://recovercovid.org/</ipd_description>
    </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/NCT05965752
  org study id: Pro00112477
  secondary id: OTA-21-015G
  nct id: NCT05965752
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This platform protocol is designed to be flexible so that it is suitable for a wide range of
        settings within health care systems, for remote settings, and in community settings where it
        can be integrated into COVID-19 programs and subsequent treatment plans.
  
        This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform
        trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The
        hypothesis is that PASC-mediated declines in cognitive domains, such as executive function
        and attention, may be improved by interventions that selectively focus on enhancing those
        domains.
  Participants will be randomized to one of the intervention appendices that are actively
        enrolling at the time of randomization. Intervention appendices may be added or removed
        according to adaptive design and/or emerging evidence. Various interventions will be studied.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: To achieve blinding and an equitable randomization probability, a two-step randomization process will be used. The study will employ a simple (unstratified) randomization scheme.
  At the first stage, each participant will be assigned with equal probability to one of the intervention appendices for which the participant is eligible, after applying any intervention-specific safety exclusions. At the second stage, each participant will be assigned according to the specific appendix's randomization procedure. Participants will have an equal chance of being randomized into any of the intervention groups.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: Participants assigned to active comparator will be considered part of pooled analyses if the intervention was active at the time of the participant's enrollment and the participants were eligible to receive that intervention. This will result in approximately a 1:1 allocation ratio for any intervention to pooled control.
  Sites will be informed to which intervention appendix participants are randomized, but, when applicable, not whether the participants are allocated to the active intervention arm or active comparator arm within that appendix. The participants and investigators will be blinded throughout the study, when possible.
  If open intervention appendices do not have the ability to pool controls but have independent controls, at the second stage participants will be randomized in a 1:1 ratio to intervention vs active comparator inside the specific intervention appendix the participants were randomized to at the first stage of the randomization procedure.
  measure: Change in Everyday Cognition 2 (ECog2)
  time frame: Baseline to End of Intervention (EOI) (Day 70)
  description: Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.
  measure: Change in PROMIS-cognitive function - short form 8a (PROMIS-Cog) total score
  time frame: Baseline, EOI (Day 70), End of Study (EOS) (Day 160)
  description: The PROMIS-Cog is the PROMIS short form for the cognitive function domain and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days.
  measure: Change on an objective neurocognitive battery scores
  time frame: Baseline, EOI (Day 70), EOS (Day 160)
  measure: Change in Everyday Cognition 2 (ECog2)
  time frame: Baseline, EOS (Day 160)
  description: Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure the participant's simple reaction time; respond when X happens and Choice reaction time; respond only if X happens.
  measure: Characterize the intervention's safety as measured by the proportion of Serious Adverse Events
  time frame: Baseline to EOS (Day 160)
  arm group label: BrainHQ Active Comparator
  arm group type: Active Comparator
  description: 5 sessions/week at 30 min/session
  arm group label: BrainHQ
  arm group type: Experimental
  description: 5 sessions/week at 30 min/session
  arm group label: BrainHQ + PASC CoRE
  arm group type: Experimental
  description: BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
  arm group label: Brain HQ + tDCS-active
  arm group type: Experimental
  description: 2.0 mA stimulation delivered for 30 min during each BrainHQ session
  arm group label: Brain HQ + tDCS-sham
  arm group type: Placebo Comparator
  description: Inactive stimulation delivered for 30 min during each BrainHQ session
  intervention type: Other
  intervention name: BrainHQ/Active Comparator Activity
  description: BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
  arm group label: BrainHQ Active Comparator
  intervention type: Other
  intervention name: BrainHQ
  description: BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
  arm group label: Brain HQ + tDCS-active
  arm group label: Brain HQ + tDCS-sham
  arm group label: BrainHQ
  arm group label: BrainHQ + PASC CoRE
  intervention type: Other
  intervention name: PASC CoRE
  description: Goal-oriented attentional self-regulation (GOALS) is a manualized, adaptable cognitive rehabilitation intervention with demonstrated efficacy in improving attention and executive functions, among other cognitive domains.
  arm group label: BrainHQ + PASC CoRE
  intervention type: Device
  intervention name: tDCS-active
  description: Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
  The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
  arm group label: Brain HQ + tDCS-active
  intervention type: Device
  intervention name: tDCS-sham
  description: tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
  arm group label: Brain HQ + tDCS-sham
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kanecia Zimmerman, MD PhD
  role: Study Chair
  affiliation: Duke University
  last name: Daniel Laskowitz, MD MHS
  role: Study Chair
  affiliation: Duke University
  facility: 
  facility: 
  facility: 
  country: United States
  url: http://recovercovid.org/
  description: Related Info
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Post-Acute COVID-19 Syndrome
  mesh term: Cognitive Dysfunction
  sharing ipd: No
  ipd description: The investigators will share the summary of results on the study website: https://recovercovid.org/