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/NCT05962281</url>
    </required_header>
    <id_info>
      <org_study_id>B1152023000005</org_study_id>
      <secondary_id>BOF23DOCBL02</secondary_id>
      <nct_id>NCT05962281</nct_id>
    </id_info>
    <brief_title>Investigation The Effect of Conventional Vs. Individualized tDCS Intensity to Achieve Uniform E-Fields</brief_title>
    <official_title>Investigation The Effect of Conventional Vs. Individualized Transcranial Direct Current Stimulation Intensity to Achieve Uniform E-Fields</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koen Cuypers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>BOF-BILA</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hasselt University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Replications of studies employing transcranial direct stimulation (tDCS) shows&#xD;
        great variations in physiological and behavioral outcomes. The disparity between studies is&#xD;
        based on the expectations of getting the same cortical activity changes consistently once the&#xD;
        procedures and current parameters have been repeated. Nevertheless, this assumption was&#xD;
        inoperative, due to the individualized variations of numerous parameters such as: age,&#xD;
        disease type, symptom severity, head geometry, etc.&#xD;
  &#xD;
        Objective: Through this clinical trial we aim to reduce the variability of the physiological&#xD;
        and behavioral outcomes of tDCS by individualizing the current intensity and to study the&#xD;
        neurophysiological and behavioral outcome differences between participants who receive the&#xD;
        customized current intensity in comparison to the others who would receive a fixed dose.&#xD;
  &#xD;
        Methods: Based on individual patient's structural MRI images, the Electrical field (E-field)&#xD;
        distribution can be modeled and the individualized current dose to stimulate a target region&#xD;
        can be determined. A group of thirty persons with multiple sclerosis (PWMS) would be&#xD;
        pseudo-randomized into three groups receiving all 3 treatments of individualized tDCS, fixed&#xD;
        currents (2 mA), and sham tDCS. Baseline and post-intervention assessment of physiological&#xD;
        and behavioral outcome measures will be assessed using respectively, transcranial magnetic&#xD;
        stimulation (TMS) recruitment curve and a stop-signal task and GO/No-go test.&#xD;
  &#xD;
        Significant statement and clinical relevance: Individualizing the patient's tDCS current&#xD;
        intensity will result in a better clinical outcome (i.e. more robust physiological and&#xD;
        behavioral effects), as compared to a tDCS application that is based on a fixed current.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 1, 2024</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Transcranial Magnetic Stimulation (TMS) Assessment</measure>
      <time_frame>Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).</time_frame>
      <description>Changes in cortical excitability will be measured by single and paired TMS pulses.&#xD;
  The final values will be assessed for improvements.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Behavioral Assessment</measure>
      <time_frame>Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).</time_frame>
      <description>A cognitive test battery consisting of:&#xD;
  1- Symbol Digit Modality Test (SDMT); the final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110, where higher scores indicating better outcome, and the lower scores indicating worse outcome.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Neurophysiologic Abnormality</condition>
    <arm_group>
      <arm_group_label>Individualized tDCS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fixed currents tDCS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All of the participant will receive standardized dose of tDCS currents intensity of 2 mA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham tDCS</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The electrodes will applied to the cortical areas, however none of all of the participant will receive the current dose of tDCS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial direct current stimulation (tDCS)</intervention_name>
      <description>Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation which involves the use of low intensity currents propagated via the scalp, is widely implemented as both a fundamental and clinical neuroscientific tool. Over the last decades, tDCS showed significant therapeutic promise, as numerous studies revealed that it can result in improved attention and executive functions in patients with neurological disorders, through modification of neuronal excitability.</description>
      <arm_group_label>Fixed currents tDCS</arm_group_label>
      <arm_group_label>Individualized tDCS</arm_group_label>
      <arm_group_label>Sham tDCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Right-handed volunteers, assessed by Edinburgh handedness inventory&#xD;
  &#xD;
            -  Normal or corrected-to-normal vision&#xD;
  &#xD;
            -  Greater than or equal to 18 years old&#xD;
  &#xD;
            -  Relapsing-remitting type of MS (RRMS)&#xD;
  &#xD;
            -  Moderate disability EDSS score ≤ 6.5&#xD;
  &#xD;
            -  Free of relapsing attack at least a month before recruitment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject recently had a seizure or epilepsy&#xD;
  &#xD;
            -  Subject is a habitual smoker;&#xD;
  &#xD;
            -  Subject has a history of any major disease that may interfere with the investigations&#xD;
               (especially liver and kidney disease, upper limb pathologies, history of significant&#xD;
               multiple traumas, or diabetes) or cancer;&#xD;
  &#xD;
            -  Subject has any history of a major neurological disorder in addition to MS (including&#xD;
               previous severe brain trauma and cognitive impairment) or known cerebral structural&#xD;
               abnormalities;&#xD;
  &#xD;
            -  Subject has a diagnosed mental disorder (e.g., depression, bipolar disorder,&#xD;
               schizophrenia, psychoses);&#xD;
  &#xD;
            -  Subject is currently a user (including ''recreational use'') of any illicit drugs or&#xD;
               has a history of drug or alcohol abuse;&#xD;
  &#xD;
            -  Subject has significant abnormalities on T1/T2 MRI scan;&#xD;
  &#xD;
            -  Subject has a contra-indication for MRI scanning or TMS measurements (see screening&#xD;
               forms for MRI and TMS);&#xD;
  &#xD;
            -  Subject does not understand the study procedure;&#xD;
  &#xD;
            -  Subject is unwilling or unable to perform all study procedures, or is considered&#xD;
               unsuitable in any way by the principal investigator;&#xD;
  &#xD;
            -  Subject is not able to perform the motor tasks;&#xD;
  &#xD;
            -  Subject is (potentially) pregnant (in case of doubt, hCG test will be conducted in&#xD;
               female participants); subject is breastfeeding at the time of the study;&#xD;
  &#xD;
            -  Subject chronically uses medication, especially sedatives or sleep medication&#xD;
               (contraceptives allowed). Other medication that is only taken as needed will be&#xD;
               allowed at the investigator's discretion;&#xD;
  &#xD;
            -  Using TMS, no (sufficiently stable) MEPs can be evoked at left M1;&#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>Koen Cuypers, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UHasselt</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hussein Youssef, MSc</last_name>
      <phone>+32488332512</phone>
      <email>youssef.hussein@uhasselt.be</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Hasselt University</investigator_affiliation>
      <investigator_full_name>Koen Cuypers</investigator_full_name>
      <investigator_title>Assoc. Prof.</investigator_title>
    </responsible_party>
    <keyword>Multiple Sclerosis</keyword>
    <keyword>Brain Stimulation</keyword>
    <keyword>Non-invasive Brain Stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962281
  org study id: B1152023000005
  secondary id: BOF23DOCBL02
  nct id: NCT05962281
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Background: Replications of studies employing transcranial direct stimulation (tDCS) shows
        great variations in physiological and behavioral outcomes. The disparity between studies is
        based on the expectations of getting the same cortical activity changes consistently once the
        procedures and current parameters have been repeated. Nevertheless, this assumption was
        inoperative, due to the individualized variations of numerous parameters such as: age,
        disease type, symptom severity, head geometry, etc.
  
        Objective: Through this clinical trial we aim to reduce the variability of the physiological
        and behavioral outcomes of tDCS by individualizing the current intensity and to study the
        neurophysiological and behavioral outcome differences between participants who receive the
        customized current intensity in comparison to the others who would receive a fixed dose.
  
        Methods: Based on individual patient's structural MRI images, the Electrical field (E-field)
        distribution can be modeled and the individualized current dose to stimulate a target region
        can be determined. A group of thirty persons with multiple sclerosis (PWMS) would be
        pseudo-randomized into three groups receiving all 3 treatments of individualized tDCS, fixed
        currents (2 mA), and sham tDCS. Baseline and post-intervention assessment of physiological
        and behavioral outcome measures will be assessed using respectively, transcranial magnetic
        stimulation (TMS) recruitment curve and a stop-signal task and GO/No-go test.
  
        Significant statement and clinical relevance: Individualizing the patient's tDCS current
        intensity will result in a better clinical outcome (i.e. more robust physiological and
        behavioral effects), as compared to a tDCS application that is based on a fixed current.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Screening
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Transcranial Magnetic Stimulation (TMS) Assessment
  time frame: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
  description: Changes in cortical excitability will be measured by single and paired TMS pulses.
  The final values will be assessed for improvements.
  measure: Behavioral Assessment
  time frame: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
  description: A cognitive test battery consisting of:
  1- Symbol Digit Modality Test (SDMT); the final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110, where higher scores indicating better outcome, and the lower scores indicating worse outcome.
  arm group label: Individualized tDCS
  arm group type: Active Comparator
  description: Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents.
  arm group label: Fixed currents tDCS
  arm group type: Active Comparator
  description: All of the participant will receive standardized dose of tDCS currents intensity of 2 mA.
  arm group label: Sham tDCS
  arm group type: Sham Comparator
  description: The electrodes will applied to the cortical areas, however none of all of the participant will receive the current dose of tDCS.
  intervention type: Device
  intervention name: Transcranial direct current stimulation (tDCS)
  description: Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation which involves the use of low intensity currents propagated via the scalp, is widely implemented as both a fundamental and clinical neuroscientific tool. Over the last decades, tDCS showed significant therapeutic promise, as numerous studies revealed that it can result in improved attention and executive functions in patients with neurological disorders, through modification of neuronal excitability.
  arm group label: Fixed currents tDCS
  arm group label: Individualized tDCS
  arm group label: Sham tDCS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Koen Cuypers, PhD
  role: Principal Investigator
  affiliation: UHasselt
  last name: Hussein Youssef, MSc
  phone: +32488332512
  email: youssef.hussein@uhasselt.be
  responsible party type: Sponsor-Investigator
  investigator affiliation: Hasselt University
  investigator full name: Koen Cuypers
  investigator title: Assoc. Prof.
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: No