<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/NCT03809936</url>
  </required_header>
  <id_info>
    <org_study_id>tDCS</org_study_id>
    <nct_id>NCT03809936</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness</brief_title>
  <official_title>Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To date, several studies have focused on the use of transcranial direct current&#xD;
      stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects&#xD;
      have been variously documented.So,in this study ,investigators explore the effects of tDCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:tDCS was supposed as an experimental approach to disorders of consciousness&#xD;
      treatment. Its therapeutic effects have been variously documented.&#xD;
&#xD;
      Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and&#xD;
      the clinical response of patients with disorders of consciousness and explore the&#xD;
      neuromodulatory effects of highfrequency tDCS in DOC.&#xD;
&#xD;
      Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to&#xD;
      the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of&#xD;
      consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately&#xD;
      after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery&#xD;
      Scale-Revised (CRS-R) scale and EEG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 2, 2020</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>Using a sham-controlled randomized double-blind design, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the JFK Coma Recovery Scale-Revised (CRS-R) scale</measure>
    <time_frame>at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.</time_frame>
    <description>The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EEG data ( electrophysiological parameters)</measure>
    <time_frame>at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).</time_frame>
    <description>delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Disorder of Consciousness</condition>
  <arm_group>
    <arm_group_label>real tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>real tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>real tDCS</intervention_name>
    <description>Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.</description>
    <arm_group_label>real tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham tDCS</intervention_name>
    <description>For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.</description>
    <arm_group_label>sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of DOC&#xD;
&#xD;
          2. Ages 14 to 65 years old&#xD;
&#xD;
          3. No centrally acting drugs&#xD;
&#xD;
          4. No neuromuscular function blockers and no sedation within the prior 24 hours;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History with nervous or spirit disorders, or some other serious diseases&#xD;
&#xD;
          2. A contraindication for tDCS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benyan Luo</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital, Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hangzhou Hospital of Zhejiang CAPR</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tDCS</keyword>
  <keyword>EEG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03809936
org study id: tDCS
nct id: NCT03809936
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To date, several studies have focused on the use of transcranial direct current
      stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects
      have been variously documented.So,in this study ,investigators explore the effects of tDCS.
Background:tDCS was supposed as an experimental approach to disorders of consciousness
      treatment. Its therapeutic effects have been variously documented.

      Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and
      the clinical response of patients with disorders of consciousness and explore the
      neuromodulatory effects of highfrequency tDCS in DOC.

      Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to
      the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of
      consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately
      after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery
      Scale-Revised (CRS-R) scale and EEG.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Using a sham-controlled randomized double-blind design, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: the JFK Coma Recovery Scale-Revised (CRS-R) scale
time frame: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.
description: The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
measure: EEG data ( electrophysiological parameters)
time frame: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).
description: delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery.
arm group label: real tDCS
arm group type: Active Comparator
description: real tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.
arm group label: sham tDCS
arm group type: Sham Comparator
description: sham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.
intervention type: Device
intervention name: real tDCS
description: Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
arm group label: real tDCS
intervention type: Device
intervention name: sham tDCS
description: For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.
arm group label: sham tDCS
criteria: 
gender: All
minimum age: 14 Years
maximum age: 80 Years
healthy volunteers: No
last name: Benyan Luo
role: Principal Investigator
affiliation: The First Affiliated Hospital, Zhejiang University
facility: 
country: China
responsible party type: Sponsor
mesh term: Consciousness Disorders
sharing ipd: No