<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/NCT03256500</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400807</org_study_id>
    <nct_id>NCT03256500</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation for the Treatment of Delirium</brief_title>
  <official_title>Transcranial Direct Current Stimulation for the Treatment of Delirium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Florida/South Georgia Veterans Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Florida/South Georgia Veterans Health System</source>
  <brief_summary>
    <textblock>
      Delirium is induced by changes in cortical excitability and transcranial direct current&#xD;
      stimulation (tDCS), by using weak electrical fields, can modulate cortical excitability and&#xD;
      spontaneous firing activities in the stimulated region by shifting the resting membrane. One&#xD;
      half of the subjects will receive stimulation via tDCS and the other half will receive sham&#xD;
      tDCS for 20 minutes per day, 5 days per week, for 1 week. Symptoms will be monitored using&#xD;
      the Confusion Assessment Method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hospitalized patients with delirium, who are over age 21, will be the subjects for this&#xD;
      research study. This will include both men and women at the Malcom Randall Veterans Affairs&#xD;
      Hospital. The presence of delirium will be determined by the &quot;Confusion Assessment Method&#xD;
      (CAM)&quot; which is a standardized evidence-based tool that enables clinicians to identify&#xD;
      patients who are suffering with delirium. The CAM and the CAM-ICU have been reported to have&#xD;
      a sensitivity of 94-100% with a specificity of 89-95%, together with a high inter-rater&#xD;
      reliability (Wei, Fearing, Eliezer, Sternberg, &amp; Inouye, 2008).&#xD;
&#xD;
      Patients with agitation at the moment of the procedure, pregnancy or patients with history of&#xD;
      epilepsy or show evidence of epilepsy on their EEG will be excluded.&#xD;
&#xD;
      As part of their routine medical care all participants will be fully evaluated for the&#xD;
      possible causes of delirium including: neurological disorders (CT or MRI, EEG, possible LP);&#xD;
      failure of vital organs (cardiac, hepatic, renal, pulmonary), metabolic disorders (e.g.&#xD;
      abnormalities of blood chemistries), endocrine disorders (e.g., abnormal thyroid function&#xD;
      tests), infections (e.g., urinary, pulmonary, sepsis), toxins-drugs-medications, and&#xD;
      deficiency states (B1, B12, etc). These conditions will be treated accordingly by their&#xD;
      primary provider. There will be no change in the rest of the care that the patient will get&#xD;
      when they get hospitalized.&#xD;
&#xD;
      Because patients with delirium lack the capacity to consent, the consent will be obtained&#xD;
      from a legally authorized representative who is usually the spouse, adult child, a relative&#xD;
      or a close friend. The legally authorized representative or guardian advocate who can make&#xD;
      decisions on the patient's behalf, will be appointed by the legal authorities. They can be a&#xD;
      health care surrogate/agent appointed by the person in a Durable Power of Attorney for Health&#xD;
      Care (DPAHC) or similar document. The legally authorized representative can also be a court&#xD;
      appointed guardian. If the patient/patient's legal representative decides to participate in&#xD;
      the study, the Principal Investigator will collect private information about the patient's&#xD;
      health, which is called Protected Health Information (PHI). The protected health information&#xD;
      will be then be coded and each subject will be given a unique identification number before&#xD;
      entering it into the password protected folder on the server. Once eligibility is determined,&#xD;
      the information is obtained from the medical records regarding psychiatric disorders,&#xD;
      neurological conditions, cardiac conditions, current medications, study results, age &lt; 89 in&#xD;
      numerical values, sex, education level and details regarding any tests or procedures done.&#xD;
&#xD;
      A neurocognitive assessment will be done on all the patients identified as potential subjects&#xD;
      for the study. The assessment will be done by Uma Suryadevara, Colleen Campbell, Ronald&#xD;
      Shorr, Kenneth Heilman, Laurence Solberg, Andrew Pierce or Joseph Thornton. After the&#xD;
      assessment is done, subjects are assigned into two groups, one group that gets the sham and&#xD;
      group that gets the real treatment. One half of the subjects will receive sham and the other&#xD;
      half will receive tDCS. The Soterix Medical 1x1 line of low-intensity tDCS stimulators which&#xD;
      we plan to use is designed to generate low levels of direct current between one anode and one&#xD;
      cathode placed on the body. The current enters the body through the positive electrode, the&#xD;
      anode exits the body through the negative electrode, the cathode. The accessories provided&#xD;
      with the device allow for simple and comfortable positioning of the electrodes on the body.&#xD;
      The procedure will be done by Uma Suryadevara who went through the training and is certified&#xD;
      and Colleen Campbell will activate the sham in some patients. Laurence Solberg, Ronald shorr,&#xD;
      Andrew Pierce and Joseph Thornton will do the procedure after being trained. Adam Woods is&#xD;
      the expert in tDCS and has been teaching this procedure for sometime now and will help us&#xD;
      with the process. The transcranial Direct Current Stimulator has the option of activating or&#xD;
      deactivating the 'sham'. All participants will be treated with sham or real tDCS for 20&#xD;
      minutes per day, 5 days per week, for 1 week during their hospitalization. The person&#xD;
      performing the neurocognitive assessment will be unaware if the participant is receiving sham&#xD;
      or tDCS. The electrodes will be placed over the left and right frontal lobes, near the&#xD;
      dorsolateral prefrontal cortex, (anode on the left and cathode on the right) using the&#xD;
      International 10-20 system as a guide for electrode placement. (Poreisz et al., 2007; Nitsche&#xD;
      et al, 2012. tDCS utilizes either two saline-soaked sponge or electrode gel coated electrodes&#xD;
      affixed to the scalp, which causes a weak electrical current. The maximum output of the&#xD;
      current is 2 milliamp and each electrode has an area of 25-35 cm^2. For stimulation in the&#xD;
      experimental condition, a current of 1.0-2.0 milliamps will be used, which is gradually&#xD;
      increased and decreased to achieve this target current over 30 seconds. Vitals will be taken&#xD;
      before and after tDCS treatments. Both before stimulation and after stimulation on each day,&#xD;
      as well as daily one week after stimulation, subjects will undergo an assessment for change&#xD;
      in symptoms using the Memorial Delirium Assessment Scale (MDAS). Since the effects of the&#xD;
      stimulation may last for a short time post stimulation testing will begin approximately 5&#xD;
      minutes after the stimulation and be completed within one hour. Testing will also be done one&#xD;
      more time later that afternoon to measure the change in symptoms.&#xD;
&#xD;
      The coded information and the details of the treatment will be stored on a computer server&#xD;
      with secure passwords. This information will then be used to test the effects of transcranial&#xD;
      Direct Current Stimulation on the symptomatic treatment of delirium. The neurocognitive tests&#xD;
      which include both the Confusion Assessment Method and the Memorial Delirium Assessment Scale&#xD;
      will be used to assess the symptomatic improvement. Once this information is collected, it&#xD;
      will be a part of the research record for the study. This information will be retained&#xD;
      according to the VA policies. The subjects will get the rest of the treatment as usual. For&#xD;
      example, any infections will be treated, electrolyte abnormalities will be corrected,&#xD;
      offending agents like drugs or toxins will be discontinued, deficiencies will be corrected.&#xD;
      If there is any failure of vital organs or if there are any neurological disorders,&#xD;
      appropriate treatments will be provided as per standards. The patients will then be&#xD;
      discharged as appropriate.&#xD;
&#xD;
      Procedures for recruiting and consenting:&#xD;
&#xD;
      Target population: Hospitalized patients with an established diagnosis of delirium using the&#xD;
      'Confusion Assessment Method'.&#xD;
&#xD;
      Delirium is commonly associated with increased mortality and morbidity. It is also associated&#xD;
      with prolonged hospitalization, increased nursing demands and need for use of physical and&#xD;
      pharmacological restraints. Patients with delirium represent a vulnerable population for who&#xD;
      we don't have many successful treatment options. Hence, any successful symptomatic treatment&#xD;
      that would decrease the severity will be valuable.&#xD;
&#xD;
      Patients who are admitted to the inpatient unit, with a diagnosis of delirium based on the&#xD;
      'Confusion Assessment Method', are identified by the treating physician. Once the guardian&#xD;
      advocate or legally authorized representative is appointed by the legal authorities, consent&#xD;
      will be obtained for their participation in research by the physician. The guardian advocate&#xD;
      or legally authorized representative is usually the spouse, adult child, a relative or a&#xD;
      close friend. They will be given all information about the study, who to call for questions,&#xD;
      why the study is being done, what to expect if they participate in the study and how long the&#xD;
      study will last. They will also be given the risks and benefits of this study, possible&#xD;
      adverse reactions, the information that will be collected and who will have access to it.&#xD;
      They will also be made aware of the option of withdrawing from the study at any point. Once&#xD;
      they withdraw the health information will not be collected.&#xD;
&#xD;
      If the patient/patient's legal representative decides to participate in the study, the&#xD;
      Principal Investigator will collect private information about the patient's health, which is&#xD;
      called PHI. (Protected Health Information). The protected health information will be then be&#xD;
      coded before entering it into the password protected folder on the server. The information&#xD;
      will be collected and shared with others involved in the research to determine eligibility.&#xD;
      The information is obtained from the medical records regarding psychiatric disorders,&#xD;
      neurological conditions, cardiac conditions, current medications, study results, age &lt; 89 in&#xD;
      numerical values, sex, education level and details regarding any tests or procedures done.&#xD;
&#xD;
      The information will be stored on a computer server with secure passwords. This information&#xD;
      will then be used to test the effects of transcranial Direct Current Stimulation on the&#xD;
      symptomatic treatment of delirium. The neurocognitive tests which include both the Confusion&#xD;
      Assessment Method and the Memorial Delirium Assessment Scale will be used to assess the&#xD;
      symptomatic improvement. Once this information is collected, it will be a part of the&#xD;
      research record for the study. People who will have access to this information will be the&#xD;
      Principal Investigator and research staff associated with the project.&#xD;
&#xD;
      While obtaining the informed consent, it will be explained to the legal authorized&#xD;
      representative that they are not required to sign the consent and the refusal will not affect&#xD;
      the standard treatment in any way. During the hospitalization, the participants and the&#xD;
      non-participants will continue to get the standard treatment for delirium. The providers will&#xD;
      evaluate for the cause of the delirium by: getting blood chemistries to rule out metabolic&#xD;
      disorders, ruling out infections (e.g., urinary, pulmonary, sepsis),&#xD;
      toxins-drugs-medications, deficiency states like B1, B2 etc, failure of vital organs&#xD;
      (cardiac, hepatic, renal, pulmonary), neurological disorders using a CT or MRI, EEG, Lumbar&#xD;
      Puncture if indicated. If any treatable cause is identified, it will be managed accordingly.&#xD;
      Meanwhile the patient will be assessed for nutritional status, reorientation techniques will&#xD;
      be used, sensory deficits will be corrected if present. One of the hypothesis for the&#xD;
      pathophysiology of delirium is changes in cortical excitability; this research intervention&#xD;
      can modulate cortical excitability and spontaneous firing activities in the stimulated region&#xD;
      by shifting the resting membrane potential leading to symptomatic improvement in a patient&#xD;
      with delirium.&#xD;
&#xD;
      Because Delirium is a condition that causes fluctuation in cognition, it can also cause&#xD;
      fluctuating decision making capacity. The psychiatrists will evaluate for decision making&#xD;
      capacity on an ongoing basis during the study. If it any point, the subject regains the&#xD;
      capacity to consent, we will go over the consenting process again with the subject. At that&#xD;
      point if the subject decides to withdraw from the study, the decision will be respected and&#xD;
      if not, the study will continue as before.&#xD;
&#xD;
      The neurocognitive assessments will be done prior to and after the treatments if they decide&#xD;
      to participate.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      The major dependent variable will be the score on the CAM and the MDAS (modeled as a&#xD;
      continuous variable). We will perform a mixed models analysis which will compare the&#xD;
      trajectory of CAM and MDAS score among Experimental Participants versus Control Participants.&#xD;
      Because this is a pilot/exploratory study, no sample size calculations are included in this&#xD;
      protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in signs and symptoms of delirium</measure>
    <time_frame>Time points at which the measurement will be done is within 5 minutes to an hour after procedure and another one will be done 4 to 5 hours later.</time_frame>
    <description>Negative screens for delirium for at least 48 hours</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Delirium</condition>
  <condition>Confusion</condition>
  <arm_group>
    <arm_group_label>tDCS administered</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive stimulation via tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS administered</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will receive sham tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <description>One half of the subjects will receive sham and the other half will receive tDCS. The Soterix Medical 1x1 line of low-intensity tDCS stimulators which we plan to use is designed to generate low levels of direct current current between one anode and one cathode placed on the body. The current enters the body through the positive electrode, the anode exits the body through the negative electrode, the cathode. The accessories provided with the device allow for simple and comfortable positioning of the electrodes on the body.</description>
    <arm_group_label>Sham tDCS administered</arm_group_label>
    <arm_group_label>tDCS administered</arm_group_label>
    <other_name>tDCS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with presence of delirium, confirmed by &quot;Confusion Assessment Method&quot;. Age &gt;&#xD;
             21 years old Hospitalized at the Malcom Randall Veterans Affairs Hospital. Number of&#xD;
             patients who will be recruited: 100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with agitation. Pregnancy Patents with a history of epilepsy or have evidence&#xD;
             of epilepsy on their EEG. Implanted devices anywhere in the body Unstable medical&#xD;
             conditions like uncontrolled Diabetes, Hypertension Unconscious patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uma Suryadevara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malcom Randall VAMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uma Suryadevara, MD</last_name>
    <phone>352-548-6000</phone>
    <phone_ext>1454</phone_ext>
    <email>uma.suryadevara@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Colleen Campbell</last_name>
    <phone>352-376-1611</phone>
    <phone_ext>6114</phone_ext>
    <email>colleen.campbell@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Malcolm Randall Veterans Affairs Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Uma Suryadevara, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Colleen Campbell</last_name>
      <phone>352-376-1611</phone>
      <phone_ext>6114</phone_ext>
      <email>colleen.campbell@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Uma Suryadevara, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Colleen Campbell</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenneth Heilman, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ronald Shorr, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph Thornton, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurence Solberg, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adam Woods, Ph.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Pierce, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Confusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>April 6, 2020</submitted>
    <returned>April 17, 2020</returned>
  </pending_results>
  <!-- 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/NCT03256500
org study id: IRB201400807
nct id: NCT03256500
lead sponsor: 
Delirium is induced by changes in cortical excitability and transcranial direct current
      stimulation (tDCS), by using weak electrical fields, can modulate cortical excitability and
      spontaneous firing activities in the stimulated region by shifting the resting membrane. One
      half of the subjects will receive stimulation via tDCS and the other half will receive sham
      tDCS for 20 minutes per day, 5 days per week, for 1 week. Symptoms will be monitored using
      the Confusion Assessment Method.
Hospitalized patients with delirium, who are over age 21, will be the subjects for this
      research study. This will include both men and women at the Malcom Randall Veterans Affairs
      Hospital. The presence of delirium will be determined by the "Confusion Assessment Method
      (CAM)" which is a standardized evidence-based tool that enables clinicians to identify
      patients who are suffering with delirium. The CAM and the CAM-ICU have been reported to have
      a sensitivity of 94-100% with a specificity of 89-95%, together with a high inter-rater
      reliability (Wei, Fearing, Eliezer, Sternberg, & Inouye, 2008).

      Patients with agitation at the moment of the procedure, pregnancy or patients with history of
      epilepsy or show evidence of epilepsy on their EEG will be excluded.

      As part of their routine medical care all participants will be fully evaluated for the
      possible causes of delirium including: neurological disorders (CT or MRI, EEG, possible LP);
      failure of vital organs (cardiac, hepatic, renal, pulmonary), metabolic disorders (e.g.
      abnormalities of blood chemistries), endocrine disorders (e.g., abnormal thyroid function
      tests), infections (e.g., urinary, pulmonary, sepsis), toxins-drugs-medications, and
      deficiency states (B1, B12, etc). These conditions will be treated accordingly by their
      primary provider. There will be no change in the rest of the care that the patient will get
      when they get hospitalized.

      Because patients with delirium lack the capacity to consent, the consent will be obtained
      from a legally authorized representative who is usually the spouse, adult child, a relative
      or a close friend. The legally authorized representative or guardian advocate who can make
      decisions on the patient's behalf, will be appointed by the legal authorities. They can be a
      health care surrogate/agent appointed by the person in a Durable Power of Attorney for Health
      Care (DPAHC) or similar document. The legally authorized representative can also be a court
      appointed guardian. If the patient/patient's legal representative decides to participate in
      the study, the Principal Investigator will collect private information about the patient's
      health, which is called Protected Health Information (PHI). The protected health information
      will be then be coded and each subject will be given a unique identification number before
      entering it into the password protected folder on the server. Once eligibility is determined,
      the information is obtained from the medical records regarding psychiatric disorders,
      neurological conditions, cardiac conditions, current medications, study results, age < 89 in
      numerical values, sex, education level and details regarding any tests or procedures done.

      A neurocognitive assessment will be done on all the patients identified as potential subjects
      for the study. The assessment will be done by Uma Suryadevara, Colleen Campbell, Ronald
      Shorr, Kenneth Heilman, Laurence Solberg, Andrew Pierce or Joseph Thornton. After the
      assessment is done, subjects are assigned into two groups, one group that gets the sham and
      group that gets the real treatment. One half of the subjects will receive sham and the other
      half will receive tDCS. The Soterix Medical 1x1 line of low-intensity tDCS stimulators which
      we plan to use is designed to generate low levels of direct current between one anode and one
      cathode placed on the body. The current enters the body through the positive electrode, the
      anode exits the body through the negative electrode, the cathode. The accessories provided
      with the device allow for simple and comfortable positioning of the electrodes on the body.
      The procedure will be done by Uma Suryadevara who went through the training and is certified
      and Colleen Campbell will activate the sham in some patients. Laurence Solberg, Ronald shorr,
      Andrew Pierce and Joseph Thornton will do the procedure after being trained. Adam Woods is
      the expert in tDCS and has been teaching this procedure for sometime now and will help us
      with the process. The transcranial Direct Current Stimulator has the option of activating or
      deactivating the 'sham'. All participants will be treated with sham or real tDCS for 20
      minutes per day, 5 days per week, for 1 week during their hospitalization. The person
      performing the neurocognitive assessment will be unaware if the participant is receiving sham
      or tDCS. The electrodes will be placed over the left and right frontal lobes, near the
      dorsolateral prefrontal cortex, (anode on the left and cathode on the right) using the
      International 10-20 system as a guide for electrode placement. (Poreisz et al., 2007; Nitsche
      et al, 2012. tDCS utilizes either two saline-soaked sponge or electrode gel coated electrodes
      affixed to the scalp, which causes a weak electrical current. The maximum output of the
      current is 2 milliamp and each electrode has an area of 25-35 cm^2. For stimulation in the
      experimental condition, a current of 1.0-2.0 milliamps will be used, which is gradually
      increased and decreased to achieve this target current over 30 seconds. Vitals will be taken
      before and after tDCS treatments. Both before stimulation and after stimulation on each day,
      as well as daily one week after stimulation, subjects will undergo an assessment for change
      in symptoms using the Memorial Delirium Assessment Scale (MDAS). Since the effects of the
      stimulation may last for a short time post stimulation testing will begin approximately 5
      minutes after the stimulation and be completed within one hour. Testing will also be done one
      more time later that afternoon to measure the change in symptoms.

      The coded information and the details of the treatment will be stored on a computer server
      with secure passwords. This information will then be used to test the effects of transcranial
      Direct Current Stimulation on the symptomatic treatment of delirium. The neurocognitive tests
      which include both the Confusion Assessment Method and the Memorial Delirium Assessment Scale
      will be used to assess the symptomatic improvement. Once this information is collected, it
      will be a part of the research record for the study. This information will be retained
      according to the VA policies. The subjects will get the rest of the treatment as usual. For
      example, any infections will be treated, electrolyte abnormalities will be corrected,
      offending agents like drugs or toxins will be discontinued, deficiencies will be corrected.
      If there is any failure of vital organs or if there are any neurological disorders,
      appropriate treatments will be provided as per standards. The patients will then be
      discharged as appropriate.

      Procedures for recruiting and consenting:

      Target population: Hospitalized patients with an established diagnosis of delirium using the
      'Confusion Assessment Method'.

      Delirium is commonly associated with increased mortality and morbidity. It is also associated
      with prolonged hospitalization, increased nursing demands and need for use of physical and
      pharmacological restraints. Patients with delirium represent a vulnerable population for who
      we don't have many successful treatment options. Hence, any successful symptomatic treatment
      that would decrease the severity will be valuable.

      Patients who are admitted to the inpatient unit, with a diagnosis of delirium based on the
      'Confusion Assessment Method', are identified by the treating physician. Once the guardian
      advocate or legally authorized representative is appointed by the legal authorities, consent
      will be obtained for their participation in research by the physician. The guardian advocate
      or legally authorized representative is usually the spouse, adult child, a relative or a
      close friend. They will be given all information about the study, who to call for questions,
      why the study is being done, what to expect if they participate in the study and how long the
      study will last. They will also be given the risks and benefits of this study, possible
      adverse reactions, the information that will be collected and who will have access to it.
      They will also be made aware of the option of withdrawing from the study at any point. Once
      they withdraw the health information will not be collected.

      If the patient/patient's legal representative decides to participate in the study, the
      Principal Investigator will collect private information about the patient's health, which is
      called PHI. (Protected Health Information). The protected health information will be then be
      coded before entering it into the password protected folder on the server. The information
      will be collected and shared with others involved in the research to determine eligibility.
      The information is obtained from the medical records regarding psychiatric disorders,
      neurological conditions, cardiac conditions, current medications, study results, age < 89 in
      numerical values, sex, education level and details regarding any tests or procedures done.

      The information will be stored on a computer server with secure passwords. This information
      will then be used to test the effects of transcranial Direct Current Stimulation on the
      symptomatic treatment of delirium. The neurocognitive tests which include both the Confusion
      Assessment Method and the Memorial Delirium Assessment Scale will be used to assess the
      symptomatic improvement. Once this information is collected, it will be a part of the
      research record for the study. People who will have access to this information will be the
      Principal Investigator and research staff associated with the project.

      While obtaining the informed consent, it will be explained to the legal authorized
      representative that they are not required to sign the consent and the refusal will not affect
      the standard treatment in any way. During the hospitalization, the participants and the
      non-participants will continue to get the standard treatment for delirium. The providers will
      evaluate for the cause of the delirium by: getting blood chemistries to rule out metabolic
      disorders, ruling out infections (e.g., urinary, pulmonary, sepsis),
      toxins-drugs-medications, deficiency states like B1, B2 etc, failure of vital organs
      (cardiac, hepatic, renal, pulmonary), neurological disorders using a CT or MRI, EEG, Lumbar
      Puncture if indicated. If any treatable cause is identified, it will be managed accordingly.
      Meanwhile the patient will be assessed for nutritional status, reorientation techniques will
      be used, sensory deficits will be corrected if present. One of the hypothesis for the
      pathophysiology of delirium is changes in cortical excitability; this research intervention
      can modulate cortical excitability and spontaneous firing activities in the stimulated region
      by shifting the resting membrane potential leading to symptomatic improvement in a patient
      with delirium.

      Because Delirium is a condition that causes fluctuation in cognition, it can also cause
      fluctuating decision making capacity. The psychiatrists will evaluate for decision making
      capacity on an ongoing basis during the study. If it any point, the subject regains the
      capacity to consent, we will go over the consenting process again with the subject. At that
      point if the subject decides to withdraw from the study, the decision will be respected and
      if not, the study will continue as before.

      The neurocognitive assessments will be done prior to and after the treatments if they decide
      to participate.

      Statistical Analysis:

      The major dependent variable will be the score on the CAM and the MDAS (modeled as a
      continuous variable). We will perform a mixed models analysis which will compare the
      trajectory of CAM and MDAS score among Experimental Participants versus Control Participants.
      Because this is a pilot/exploratory study, no sample size calculations are included in this
      protocol.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Reduction in signs and symptoms of delirium
time frame: Time points at which the measurement will be done is within 5 minutes to an hour after procedure and another one will be done 4 to 5 hours later.
description: Negative screens for delirium for at least 48 hours
arm group label: tDCS administered
arm group type: Experimental
description: Subjects will receive stimulation via tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.
arm group label: Sham tDCS administered
arm group type: Sham Comparator
description: Subjects will receive sham tDCS (Transcranial Direct Current Stimulation) for 20 minutes per day, 5 days per week, for 1 week.
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
description: One half of the subjects will receive sham and the other half will receive tDCS. The Soterix Medical 1x1 line of low-intensity tDCS stimulators which we plan to use is designed to generate low levels of direct current current between one anode and one cathode placed on the body. The current enters the body through the positive electrode, the anode exits the body through the negative electrode, the cathode. The accessories provided with the device allow for simple and comfortable positioning of the electrodes on the body.
arm group label: Sham tDCS administered
arm group label: tDCS administered
other name: tDCS
criteria: 
gender: All
minimum age: 21 Years
maximum age: 89 Years
healthy volunteers: No
last name: Uma Suryadevara, MD
role: Principal Investigator
affiliation: Malcom Randall VAMC
last name: Uma Suryadevara, MD
phone: 352-548-6000
phone ext: 1454
email: uma.suryadevara@va.gov
last name: Colleen Campbell
phone: 352-376-1611
phone ext: 6114
email: colleen.campbell@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Delirium
mesh term: Confusion
sharing ipd: No
ipd description: There is no plan to make individual participant data available.
submitted: April 6, 2020
returned: April 17, 2020