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/NCT05983601</url>
    </required_header>
    <id_info>
      <org_study_id>2021.404.IRB.119</org_study_id>
      <secondary_id>321S329</secondary_id>
      <nct_id>NCT05983601</nct_id>
    </id_info>
    <brief_title>The Long-term Simultaneous Motor Cortex Stimulation and Balance Training</brief_title>
    <official_title>The Effect of Balance Training Combined With Motor Cortex Anodal Transcranial Direct Current Stimulation on Balance and Kinematic Parameters in Amateur Athletes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koc University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Scientific and Technological Research Council of Turkey</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Marmara University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>İstinye University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Koc University Hospital</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>
        Transcranial direct current stimulation (tDCS) is a simple, portable, and low-cost technology&#xD;
        applied in neuroscience for therapeutic purposes and neurophysiological research of brain&#xD;
        activity. Enhancing the impacts of training and improving performance in athletes through the&#xD;
        use of tDCS is a significant aim for today.&#xD;
  &#xD;
        The primary purpose of this study is to determine how non-professional active athletes'&#xD;
        balance and movement measurements can be affected by the simultaneous application of a 4-week&#xD;
        balance training and anodal tDCS of motor cortex(M1). This study hypothesizes that anodal&#xD;
        stimulation of motor cortex will enhance performance in balance training among moderately&#xD;
        active and healthy participants. The study outcomes will provide data for literatures on&#xD;
        performance enhancement by demonstrating how effective skill development can be acquired in a&#xD;
        short time among moderately active athletes. In addition, the study outcomes will provide&#xD;
        convenient tDCS parameter for future neuromodulation studies interested in the treatment of&#xD;
        balance disorders in patients and the elderly. Uniquely, in our study, the link between tDCS&#xD;
        and movement parameters will be investigated. Additionally, a long-term balance training&#xD;
        program in combination with tDCS of M1 in amateur has never been tested in amateur athletes.&#xD;
  &#xD;
        The secondary purpose of the study is to obtain feedback from participants via pre- and&#xD;
        post-tDCS and balance training, using continuous performance tests, estimated reaction time,&#xD;
        and depression-anxiety scales to gather data on reaction time, anticipation, impulsivity,&#xD;
        attention, and mood changes that directly affect athlete performance. In continuous&#xD;
        performance test, a decrease in reaction times without an increase in the number of errors&#xD;
        (misstep-commission) and the number of non-pressing (non-pressing-omission) will be&#xD;
        considered as a successful outcome. While increasing balance performance and reducing the&#xD;
        reaction time is anticipated as a positive outcome, simultaneously changes in mood,&#xD;
        attention, and error rate is an unanticipated and undesired outcome. Although the selected&#xD;
        stimulation area is not directly related to these functions, this study will additionally&#xD;
        control for any potential changes that might have been missed in functions that are not the&#xD;
        study's primary focus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Previous studies have demonstrated that the level of physical activity has an impact on&#xD;
        response of tDCS application. While several studies found no tDCS effect on participants with&#xD;
        both high and low levels of activity, it is expected to have greater impact on moderately&#xD;
        active people. However, no study has yet investigated tDCS with moderately active athletes.&#xD;
        Among studies investigating balance, only one study on healthy subjects has examined the&#xD;
        correlation of tDCS implementation with kinematic parameters, and a correlation was found&#xD;
        between increased balance performance and lower velocity parameter. By taking into account&#xD;
        the effect of kinematic parameters on sports performance, this study intends to explore the&#xD;
        effect of tDCS in greater detail by investigating both balance and movement analysis. This&#xD;
        study will investigate the impact of combined anodal tDCS of motor cortex and 4-week&#xD;
        balance-training program on static, dynamic balance and kinematic parameters in amateur&#xD;
        athletes, and measure changes in reaction time and estimated reaction time. Previous studies&#xD;
        showed that M1 anodal stimulation reduces reaction time, but estimated reaction time has&#xD;
        never been examined. At the end of simultaneous tDCS-balance training, it is expected to&#xD;
        reduce the reaction time without increasing the error rate and to achieve the expected&#xD;
        reaction time, which is significant for improving athletes' performance.&#xD;
  &#xD;
        Participants who met the requirements signed the informed consent form (BGOF) approved by the&#xD;
        Ethics Committee and applied via the advertisements posted with permission from the&#xD;
        university will be included in the study. Before the training and tDCS session, Beck&#xD;
        Depression/ Anxiety Test and Dominant Foot Test will be applied to participants. Next, they&#xD;
        will undergo a Continuous Performance Test (CPT) and an estimated reaction time test via a&#xD;
        computer program and will last 5 minutes. CPT is a test performed to assess sustained&#xD;
        attention and impulse control, where participants perform a task with a constant difficulty&#xD;
        for several minutes. In addition, anthropometric measurements will be taken from the&#xD;
        participants and these measures will be compared between sham and active groups to evaluate&#xD;
        possible differences between two groups. After these tests, participants who are not suitable&#xD;
        for the study will be eliminated, and remaining participants will be randomized into active&#xD;
        or sham tDCS groups. Next, participants will attend a balance training session designed by a&#xD;
        professional trainer to assess balance and movement parameters at the Koç University Movement&#xD;
        Analysis Laboratory. The balance training program consists of a 5-minute warm-up and a&#xD;
        20-minute main section for the first and second weeks and a 5-minute warm-up and a 24-minute&#xD;
        main section for the third and fourth weeks. The warm-up starts with a low-intensity cycling&#xD;
        ergometer or low-intensity walking/running on a treadmill, followed by static/dynamic&#xD;
        stretching exercises. During the 4-week balance training, the duration of a set is 30 seconds&#xD;
        for the first two weeks and 45 seconds for the third and fourth weeks. Each exercise will be&#xD;
        repeated twice on the right and left sides, totaling 4 repetitions. For some exercises,&#xD;
        participants will perform them with their eyes open or closed, and on single or double legs.&#xD;
        The tDCS device will be fixed on the participant's midline on their back and it will be&#xD;
        constantly controlled during the training breaks and recharged if necessary. In case&#xD;
        measurements cannot be taken due to a technical or scheduling issue, the same individuals&#xD;
        will be recalled to the laboratory within the same week and they will be instructed not to&#xD;
        engage in any extra training during that week.&#xD;
  &#xD;
        At the end of 4-week combined balance training/ tDCS, participants will return to Movement&#xD;
        Analysis Laboratory, and all tests performed at the beginning of study will be repeated.&#xD;
        Individuals who miss two consecutive training sessions or a total of three training sessions&#xD;
        in the 4-week program will be excluded from the study. To reduce the risk of this,&#xD;
        participants will be provided with weekly schedules in advance. The next suitable participant&#xD;
        identified through a pre-screening process will be included in place of those who are&#xD;
        excluded from the study. Lastly, If the required number of participants cannot be reached&#xD;
        during the initial interviews, the study announcement will be repeated and attempts will be&#xD;
        made to recruit new participants. If sufficient participants cannot be provided from the&#xD;
        Marmara University, amateur athletes who meet the research participant criteria will be&#xD;
        sought outside of university.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel controlled randomized double blind study</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes from Baseline in Dynamic Balance and Lower Extremity Functionality in Y-Balance Test Following 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per week.</measure>
      <time_frame>Baseline and Week 4</time_frame>
      <description>The Y-balance test measures dynamic balance and the functionality of lower extremity. Participants perform reach tasks in 3 different directions with their legs and the maximum length reached is recorded before and after the tDCS treatment with simultaneous balance training. Scores are calculated by taking the sum of reach direction lengths, dividing by the length of upper extremity and multiplying by 100&#xD;
  Change = (Week 4 Score - Baseline Score)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from Baseline in BESS Scores Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week</measure>
      <time_frame>Baseline and Week 4</time_frame>
      <description>The Balance Error Scoring System is a standardized assessment tool that measures static balance and postural stability. In BESS, the number of errors or deviation from the normal stance is recorded, and changes in error are compared before and after tDCS treatment with simultaneous balance training.&#xD;
  Change = (Week 4 Score - Baseline Score)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from Baseline in Movement Parameters Recorded by Noraxon Myomotion 5 IMU Sensors During the Y-Balance test and BESS Movements Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week</measure>
      <time_frame>Baseline and Week 4</time_frame>
      <description>Noraxon Myomotion 5 IMU Sensors provide a detailed analysis of kinematics by quantifying motion and movement measures in various areas. These measures will be taken while participants perform Y-Balance and BESS movements. Change from baseline in Noraxon Myomotion 5 IMU Sensors parameters will allow for the interpretation of changes in precise movements performed in these tasks.&#xD;
  Change = (Week 4 Score - Baseline Score)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes from Baseline in Sustained Attention Measured by Continuous Performance Test Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week</measure>
      <time_frame>Baseline and Week 4</time_frame>
      <description>Continuous Performance Test is a well-known measurement to evaluate the sustained attention and response inhibition. Changes in omission and commission errors in CPT task will be compared before and after tDCS treatment with simultaneous balance training.&#xD;
  Change = (Week 4 Score - Baseline Score)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Coordination and Balance Disturbances</condition>
    <arm_group>
      <arm_group_label>Active tDCS+Balance training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The current intensity will be 2mA and the duration of stimulation will be 20 minutes with direct current stimulation. In the beginning and end of the tDCS stimulation, there will be 30 second ascent and descent period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham tDCS+Balance Training</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>In sham stimulation, the current will increase to 2 mA in the first thirty second, following by 30 second active stimulation, then it will be dropped to 0 mA. Brief electric current will be given in order to create a tingling sensation under electrodes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
      <description>The anode electrode will be placed at the midline of the Cz according to international 10-20 EEG system, and the cathode electrode will be placed at the midline of forehead. In this way, both hemisphere of motor cortex can be stimulated which is used as protocol in various balance studies (Siedel-Marzi and Ragert, 2020b; Saruco et al., 2017). Participants will continue their training with tDCS (2mA) for 20 minutes. This application will continue three times a week for four weeks. In the end of the study, participants will be asked to guess which group they were in (active or sham).</description>
      <arm_group_label>Active tDCS+Balance training</arm_group_label>
      <arm_group_label>Sham tDCS+Balance Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Scoring below 19 on the Beck Depression Inventory&#xD;
  &#xD;
            -  Scoring 15 or below on the Beck Anxiety Scale&#xD;
  &#xD;
            -  Having no neurological, psychiatric, orthopedic, or inner ear-related diseases&#xD;
  &#xD;
            -  Not being a professional athlete in a branch involving balance training (e.g.,&#xD;
               gymnastics)&#xD;
  &#xD;
            -  Not using medication affecting the central nervous system&#xD;
  &#xD;
            -  Having not consumed alcohol at least 24 hours prior to the tests&#xD;
  &#xD;
            -  Having no metal implants or hip/knee prosthesis&#xD;
  &#xD;
            -  Not being pregnant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scoring 19 or higher on the Beck Depression Inventory&#xD;
  &#xD;
            -  Scoring higher than 15 on Beck Anxiety Scale&#xD;
  &#xD;
            -  Being a professional athlete&#xD;
  &#xD;
            -  Using mediation affecting the central nervous system&#xD;
  &#xD;
            -  Alcohol consumption less than 24 hours prior to the test&#xD;
  &#xD;
            -  Having metal implants or hip/knee prosthesis&#xD;
  &#xD;
            -  Being pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ezgi Tuna Erdoğan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Koç University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ezgi Tuna Erdoğan</last_name>
      <phone>+90 533 643 47 49</phone>
      <email>ezerdogan@ku.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Koç University Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>35310</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ezgi Tuna Erdoğan</last_name>
        <phone>+90 533 643 47 49</phone>
        <email>ezerdogan@ku.edu.tr</email>
      </contact>
      <investigator>
        <last_name>Ezgi Tuna Erdoğan</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Adil Deniz Duru</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Gökçer Eskikurt</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Koç University</investigator_affiliation>
      <investigator_full_name>Ezgi Tuna Erdoğan</investigator_full_name>
      <investigator_title>Ezgi Tuna Erdoğan</investigator_title>
    </responsible_party>
    <keyword>Balance training</keyword>
    <keyword>Transcranial Direct Current Stimulation</keyword>
    <keyword>Neuromodulation</keyword>
    <keyword>Non-invasive brain stimulation</keyword>
    <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/NCT05983601
  org study id: 2021.404.IRB.119
  secondary id: 321S329
  nct id: NCT05983601
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Transcranial direct current stimulation (tDCS) is a simple, portable, and low-cost technology
        applied in neuroscience for therapeutic purposes and neurophysiological research of brain
        activity. Enhancing the impacts of training and improving performance in athletes through the
        use of tDCS is a significant aim for today.
  
        The primary purpose of this study is to determine how non-professional active athletes'
        balance and movement measurements can be affected by the simultaneous application of a 4-week
        balance training and anodal tDCS of motor cortex(M1). This study hypothesizes that anodal
        stimulation of motor cortex will enhance performance in balance training among moderately
        active and healthy participants. The study outcomes will provide data for literatures on
        performance enhancement by demonstrating how effective skill development can be acquired in a
        short time among moderately active athletes. In addition, the study outcomes will provide
        convenient tDCS parameter for future neuromodulation studies interested in the treatment of
        balance disorders in patients and the elderly. Uniquely, in our study, the link between tDCS
        and movement parameters will be investigated. Additionally, a long-term balance training
        program in combination with tDCS of M1 in amateur has never been tested in amateur athletes.
  
        The secondary purpose of the study is to obtain feedback from participants via pre- and
        post-tDCS and balance training, using continuous performance tests, estimated reaction time,
        and depression-anxiety scales to gather data on reaction time, anticipation, impulsivity,
        attention, and mood changes that directly affect athlete performance. In continuous
        performance test, a decrease in reaction times without an increase in the number of errors
        (misstep-commission) and the number of non-pressing (non-pressing-omission) will be
        considered as a successful outcome. While increasing balance performance and reducing the
        reaction time is anticipated as a positive outcome, simultaneously changes in mood,
        attention, and error rate is an unanticipated and undesired outcome. Although the selected
        stimulation area is not directly related to these functions, this study will additionally
        control for any potential changes that might have been missed in functions that are not the
        study's primary focus.
  Previous studies have demonstrated that the level of physical activity has an impact on
        response of tDCS application. While several studies found no tDCS effect on participants with
        both high and low levels of activity, it is expected to have greater impact on moderately
        active people. However, no study has yet investigated tDCS with moderately active athletes.
        Among studies investigating balance, only one study on healthy subjects has examined the
        correlation of tDCS implementation with kinematic parameters, and a correlation was found
        between increased balance performance and lower velocity parameter. By taking into account
        the effect of kinematic parameters on sports performance, this study intends to explore the
        effect of tDCS in greater detail by investigating both balance and movement analysis. This
        study will investigate the impact of combined anodal tDCS of motor cortex and 4-week
        balance-training program on static, dynamic balance and kinematic parameters in amateur
        athletes, and measure changes in reaction time and estimated reaction time. Previous studies
        showed that M1 anodal stimulation reduces reaction time, but estimated reaction time has
        never been examined. At the end of simultaneous tDCS-balance training, it is expected to
        reduce the reaction time without increasing the error rate and to achieve the expected
        reaction time, which is significant for improving athletes' performance.
  
        Participants who met the requirements signed the informed consent form (BGOF) approved by the
        Ethics Committee and applied via the advertisements posted with permission from the
        university will be included in the study. Before the training and tDCS session, Beck
        Depression/ Anxiety Test and Dominant Foot Test will be applied to participants. Next, they
        will undergo a Continuous Performance Test (CPT) and an estimated reaction time test via a
        computer program and will last 5 minutes. CPT is a test performed to assess sustained
        attention and impulse control, where participants perform a task with a constant difficulty
        for several minutes. In addition, anthropometric measurements will be taken from the
        participants and these measures will be compared between sham and active groups to evaluate
        possible differences between two groups. After these tests, participants who are not suitable
        for the study will be eliminated, and remaining participants will be randomized into active
        or sham tDCS groups. Next, participants will attend a balance training session designed by a
        professional trainer to assess balance and movement parameters at the Koç University Movement
        Analysis Laboratory. The balance training program consists of a 5-minute warm-up and a
        20-minute main section for the first and second weeks and a 5-minute warm-up and a 24-minute
        main section for the third and fourth weeks. The warm-up starts with a low-intensity cycling
        ergometer or low-intensity walking/running on a treadmill, followed by static/dynamic
        stretching exercises. During the 4-week balance training, the duration of a set is 30 seconds
        for the first two weeks and 45 seconds for the third and fourth weeks. Each exercise will be
        repeated twice on the right and left sides, totaling 4 repetitions. For some exercises,
        participants will perform them with their eyes open or closed, and on single or double legs.
        The tDCS device will be fixed on the participant's midline on their back and it will be
        constantly controlled during the training breaks and recharged if necessary. In case
        measurements cannot be taken due to a technical or scheduling issue, the same individuals
        will be recalled to the laboratory within the same week and they will be instructed not to
        engage in any extra training during that week.
  
        At the end of 4-week combined balance training/ tDCS, participants will return to Movement
        Analysis Laboratory, and all tests performed at the beginning of study will be repeated.
        Individuals who miss two consecutive training sessions or a total of three training sessions
        in the 4-week program will be excluded from the study. To reduce the risk of this,
        participants will be provided with weekly schedules in advance. The next suitable participant
        identified through a pre-screening process will be included in place of those who are
        excluded from the study. Lastly, If the required number of participants cannot be reached
        during the initial interviews, the study announcement will be repeated and attempts will be
        made to recruit new participants. If sufficient participants cannot be provided from the
        Marmara University, amateur athletes who meet the research participant criteria will be
        sought outside of university.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel controlled randomized double blind study
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Changes from Baseline in Dynamic Balance and Lower Extremity Functionality in Y-Balance Test Following 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per week.
  time frame: Baseline and Week 4
  description: The Y-balance test measures dynamic balance and the functionality of lower extremity. Participants perform reach tasks in 3 different directions with their legs and the maximum length reached is recorded before and after the tDCS treatment with simultaneous balance training. Scores are calculated by taking the sum of reach direction lengths, dividing by the length of upper extremity and multiplying by 100
  Change = (Week 4 Score - Baseline Score)
  measure: Changes from Baseline in BESS Scores Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week
  time frame: Baseline and Week 4
  description: The Balance Error Scoring System is a standardized assessment tool that measures static balance and postural stability. In BESS, the number of errors or deviation from the normal stance is recorded, and changes in error are compared before and after tDCS treatment with simultaneous balance training.
  Change = (Week 4 Score - Baseline Score)
  measure: Changes from Baseline in Movement Parameters Recorded by Noraxon Myomotion 5 IMU Sensors During the Y-Balance test and BESS Movements Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week
  time frame: Baseline and Week 4
  description: Noraxon Myomotion 5 IMU Sensors provide a detailed analysis of kinematics by quantifying motion and movement measures in various areas. These measures will be taken while participants perform Y-Balance and BESS movements. Change from baseline in Noraxon Myomotion 5 IMU Sensors parameters will allow for the interpretation of changes in precise movements performed in these tasks.
  Change = (Week 4 Score - Baseline Score)
  measure: Changes from Baseline in Sustained Attention Measured by Continuous Performance Test Following a 4-Week Simultaneous Balance Training and tDCS Treatment with 3 Sessions per Week
  time frame: Baseline and Week 4
  description: Continuous Performance Test is a well-known measurement to evaluate the sustained attention and response inhibition. Changes in omission and commission errors in CPT task will be compared before and after tDCS treatment with simultaneous balance training.
  Change = (Week 4 Score - Baseline Score)
  arm group label: Active tDCS+Balance training
  arm group type: Active Comparator
  description: The current intensity will be 2mA and the duration of stimulation will be 20 minutes with direct current stimulation. In the beginning and end of the tDCS stimulation, there will be 30 second ascent and descent period.
  arm group label: Sham tDCS+Balance Training
  arm group type: Sham Comparator
  description: In sham stimulation, the current will increase to 2 mA in the first thirty second, following by 30 second active stimulation, then it will be dropped to 0 mA. Brief electric current will be given in order to create a tingling sensation under electrodes.
  intervention type: Device
  intervention name: Transcranial Direct Current Stimulation
  description: The anode electrode will be placed at the midline of the Cz according to international 10-20 EEG system, and the cathode electrode will be placed at the midline of forehead. In this way, both hemisphere of motor cortex can be stimulated which is used as protocol in various balance studies (Siedel-Marzi and Ragert, 2020b; Saruco et al., 2017). Participants will continue their training with tDCS (2mA) for 20 minutes. This application will continue three times a week for four weeks. In the end of the study, participants will be asked to guess which group they were in (active or sham).
  arm group label: Active tDCS+Balance training
  arm group label: Sham tDCS+Balance Training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ezgi Tuna Erdoğan
  role: Principal Investigator
  affiliation: Koç University
  last name: Ezgi Tuna Erdoğan
  phone: +90 533 643 47 49
  email: ezerdogan@ku.edu.tr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Koç University
  investigator full name: Ezgi Tuna Erdoğan
  investigator title: Ezgi Tuna Erdoğan
  sharing ipd: No