<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/NCT01673126</url>
  </required_header>
  <id_info>
    <org_study_id>2009/201</org_study_id>
    <nct_id>NCT01673126</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness</brief_title>
  <acronym>tDCS in DOC</acronym>
  <official_title>Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Sham-controlled Randomised Double Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to&#xD;
      the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and&#xD;
      attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised&#xD;
      (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a&#xD;
      double-blind sham-controlled experimental design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following severe brain damage and coma, some patients may remain in a vegetative state (VS)&#xD;
      or minimally conscious state (MCS). At present, there are no evidence-based guidelines&#xD;
      regarding the treatment of patients with disorders of consciousness (DOC).&#xD;
&#xD;
      Investigator aim to assess the effect of single session anodal (i.e., excitatory)&#xD;
      transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex&#xD;
      (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham&#xD;
      controlled study.&#xD;
&#xD;
      tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at&#xD;
      stimulation sites via weak polarizing currents, previously reported to transiently improve&#xD;
      working memory and attention by stimulating the left DLPF in healthy subjects and patients&#xD;
      with stroke, Parkinson's or Alzheimer's disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">August 2010</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in CRS-R Total Scores</measure>
    <time_frame>Baseline and directly after the tDCS (20 minutes)</time_frame>
    <description>At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations&#xD;
The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.&#xD;
Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).&#xD;
The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of Diagnosis on the Results</measure>
    <time_frame>participants will be followed for the duration of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of Etiology on the Results</measure>
    <time_frame>participants will be followed for the duration of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of Time Since Insult on the Results</measure>
    <time_frame>participants will be followed for the duration of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Vegetative State</condition>
  <condition>Minimally Conscious State</condition>
  <condition>Disorders of Consciousness</condition>
  <arm_group>
    <arm_group_label>Anodal tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal tDCS</intervention_name>
    <description>patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)</description>
    <arm_group_label>Anodal tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham tDCS</intervention_name>
    <description>Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.</description>
    <arm_group_label>sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post-comatose patients&#xD;
&#xD;
          -  patients in vegetative/unresponsive or minimally conscious state&#xD;
&#xD;
          -  patients with stable cardiorespiratory parameters&#xD;
&#xD;
          -  patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine)&#xD;
             or NMDA receptor antagonists (e.g., dextromethorphan)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  premorbit neurology antecedent&#xD;
&#xD;
          -  patients in coma or &lt;1week after the acute brain insult&#xD;
&#xD;
          -  patients with a metallic cerebral implant or a pacemaker (in line with the safety&#xD;
             criteria for tDCS in humans)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Laureys, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Coma Science Group, Cyclotron Research Centre, University and University Hospital of Liège</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.</citation>
    <PMID>7818633</PMID>
  </reference>
  <reference>
    <citation>Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.</citation>
    <PMID>11839831</PMID>
  </reference>
  <reference>
    <citation>Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.</citation>
    <PMID>12949224</PMID>
  </reference>
  <reference>
    <citation>Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.</citation>
    <PMID>14580622</PMID>
  </reference>
  <reference>
    <citation>Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.</citation>
    <PMID>15999258</PMID>
  </reference>
  <reference>
    <citation>Kang EK, Kim DY, Paik NJ. Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. J Rehabil Med. 2012 Apr;44(4):346-50. doi: 10.2340/16501977-0947.</citation>
    <PMID>22434324</PMID>
  </reference>
  <reference>
    <citation>Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.</citation>
    <PMID>16843494</PMID>
  </reference>
  <reference>
    <citation>Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.</citation>
    <PMID>18525028</PMID>
  </reference>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>December 18, 2013</results_first_submitted>
  <results_first_submitted_qc>May 12, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 9, 2014</results_first_posted>
  <last_update_submitted>May 12, 2014</last_update_submitted>
  <last_update_submitted_qc>May 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Aurore Thibaut</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>vegetative state</keyword>
  <keyword>minimally conscious state</keyword>
  <keyword>disorders of consciousness</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
    <mesh_term>Persistent Vegetative State</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Anodal tDCS</title>
          <description>Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.</description>
        </group>
        <group group_id="P2">
          <title>Sham tDCS</title>
          <description>Sham tDCS during first, then 2 days of washout, then anodal tDCS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36">First stimulation (20 minutes) Washout (2 days) Second stimulation (20 minutes)</participants>
                <participants group_id="P2" count="26">First stimulation (20 minutes) Washout (2days) Second stimulation (20 minutes)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>change of diagnosis</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>36 patients received first the anodal stimulation and 26 received first the sham stimulation.&#xD;
Each patient received both stimulation exept for 7 patients. They were excluded due to diagnosis change between the 2 stimulations.</population>
      <group_list>
        <group group_id="B1">
          <title>Anodal tDCS First</title>
          <description>Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.</description>
        </group>
        <group group_id="B2">
          <title>Sham tDCS First</title>
          <description>Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="17"/>
                    <measurement group_id="B2" value="40" spread="19"/>
                    <measurement group_id="B3" value="43" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in CRS-R Total Scores</title>
        <description>At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations&#xD;
The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.&#xD;
Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).&#xD;
The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.</description>
        <time_frame>Baseline and directly after the tDCS (20 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anodal tDCS First</title>
            <description>Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).&#xD;
Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).</description>
          </group>
          <group group_id="O2">
            <title>Sham tDCS First</title>
            <description>Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).&#xD;
Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in CRS-R Total Scores</title>
          <description>At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations&#xD;
The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.&#xD;
Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).&#xD;
The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.17" spread="4.32"/>
                    <measurement group_id="O2" value="10.60" spread="4.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of Diagnosis on the Results</title>
        <time_frame>participants will be followed for the duration of 1 year</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of Etiology on the Results</title>
        <time_frame>participants will be followed for the duration of 1 year</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of Time Since Insult on the Results</title>
        <time_frame>participants will be followed for the duration of 1 year</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first stimulation to one month after the end of the 2 stimulations.</time_frame>
      <desc>We use the GOSE (Glasgow outcome scale extended) to assess a possible decrease (or inscrease) in patient status.</desc>
      <group_list>
        <group group_id="E1">
          <title>Anodal tDCS</title>
          <description>Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)&#xD;
Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)</description>
        </group>
        <group group_id="E2">
          <title>Sham tDCS</title>
          <description>Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.&#xD;
sham tDCS: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Aurore Thibaut and Pr Steven Laureys</name_or_title>
      <organization>Coma Science Group, University of Liège</organization>
      <phone>003243662362</phone>
      <email>athibaut@ulg.ac.be</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01673126
org study id: 2009/201
nct id: NCT01673126
lead sponsor: 
has dmc: No
Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to
      the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and
      attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised
      (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a
      double-blind sham-controlled experimental design.
Following severe brain damage and coma, some patients may remain in a vegetative state (VS)
      or minimally conscious state (MCS). At present, there are no evidence-based guidelines
      regarding the treatment of patients with disorders of consciousness (DOC).

      Investigator aim to assess the effect of single session anodal (i.e., excitatory)
      transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex
      (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham
      controlled study.

      tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at
      stimulation sites via weak polarizing currents, previously reported to transiently improve
      working memory and attention by stimulating the left DLPF in healthy subjects and patients
      with stroke, Parkinson's or Alzheimer's disease.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in CRS-R Total Scores
time frame: Baseline and directly after the tDCS (20 minutes)
description: At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations
The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.
Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).
The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.
measure: Influence of Diagnosis on the Results
time frame: participants will be followed for the duration of 1 year
measure: Influence of Etiology on the Results
time frame: participants will be followed for the duration of 1 year
measure: Influence of Time Since Insult on the Results
time frame: participants will be followed for the duration of 1 year
arm group label: Anodal tDCS
arm group type: Active Comparator
description: Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)
arm group label: sham tDCS
arm group type: Sham Comparator
description: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
intervention type: Device
intervention name: Anodal tDCS
description: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)
arm group label: Anodal tDCS
intervention type: Device
intervention name: sham tDCS
description: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
arm group label: sham tDCS
criteria: 
gender: All
minimum age: 15 Years
maximum age: 75 Years
healthy volunteers: No
last name: Steven Laureys, MD, PhD
role: Study Chair
affiliation: Coma Science Group, Cyclotron Research Centre, University and University Hospital of Liège
facility: 
country: Belgium
citation: Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.
PMID: 7818633
citation: Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.
PMID: 11839831
citation: Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.
PMID: 12949224
citation: Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
PMID: 14580622
citation: Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
PMID: 15999258
citation: Kang EK, Kim DY, Paik NJ. Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. J Rehabil Med. 2012 Apr;44(4):346-50. doi: 10.2340/16501977-0947.
PMID: 22434324
citation: Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.
PMID: 16843494
citation: Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
PMID: 18525028
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Aurore Thibaut
investigator title: Principal Investigator
mesh term: Consciousness Disorders
mesh term: Persistent Vegetative State
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 