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/NCT06039605</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00015655</org_study_id>
      <nct_id>NCT06039605</nct_id>
    </id_info>
    <brief_title>Priming Expectations and Motor Learning With tDCS</brief_title>
    <official_title>Effects of Modulating Expectations About Noninvasive Brain Stimulation on Motor Learning</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arizona State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arizona State 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to test if priming expectations of transcranial Direct Current&#xD;
        Stimulation (tDCS) can improve the efficacy of tDCS in enhancing motor learning.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Transcranial direct current stimulation (tDCS) is currently being investigated by the&#xD;
        scientific community as an intervention to improve motor learning in the context of&#xD;
        neurorehabilitation (e.g., recover lost motor function after stroke) and performance&#xD;
        enhancement (e.g., improve sports or technical skill training). More importantly, consumers&#xD;
        believe that tDCS works. The expectation surrounding the benefits of tDCS for skill&#xD;
        enhancement is so pervasive that the technology is sold for less than $200 and highly rated&#xD;
        by the general public on Amazon.com. At the same time, there is considerable skepticism&#xD;
        within the motor control field regarding the efficacy and mechanism of action of tDCS on&#xD;
        motor learning, driven by highly irreproducible and equivocal findings between and even&#xD;
        within laboratories.&#xD;
  &#xD;
        How effective is tDCS, and could the positive effects of tDCS be attributable in part to a&#xD;
        strong placebo effect? Placebo effects (i.e., a positive expectation associated with positive&#xD;
        treatment outcomes), are well documented in other interventions like surgeries and&#xD;
        pharmaceuticals, but have not been investigated in detail for tDCS, particularly in the motor&#xD;
        domain. The lack of knowledge or consideration of the placebo effect may therefore explain&#xD;
        why tDCS findings are so inconsistent within motor learning. Thus, the overall aim of this&#xD;
        project is to determine whether people's expectations about tDCS change as a function of&#xD;
        information about tDCS itself, and whether these changed expectations modulate the effects of&#xD;
        tDCS on motor learning.&#xD;
  &#xD;
        Transcranial direct current stimulation (tDCS) is a noninvasive, safe cortical stimulation&#xD;
        technique that has been effectively used for enhancing and inhibiting sensory and motor&#xD;
        performance when applied to the responsible cortical areas in healthy adults. For instance,&#xD;
        anodal tDCS of primary motor area can improve motor execution. Recent research has&#xD;
        investigated whether it is the expectation of receiving tDCS that has a greater impact on&#xD;
        behavioral outcomes compared to the actual application of tDCS. This is important as many&#xD;
        domains of science are challenged to reproduce previous research demonstrating a positive&#xD;
        effect of tDCS on behavior. Thus, to decipher legitimate effects of tDCS on behavior it is&#xD;
        important to quantify and compare how changes in behavior are related to tDCS, a key metric&#xD;
        related to strength of the placebo effect, and how malleable these placebo effects are.&#xD;
  &#xD;
        Individuals may participate in this study for up to four sessions (up to 3 training sessions&#xD;
        and up to 1 follow-up visit, as assigned) in the span of approximately one week. The&#xD;
        investigators expect that individuals will spend up to one hour during the training sessions,&#xD;
        and (if applicable) around 15 minutes to complete the follow-up visit, if assigned. The&#xD;
        follow-up visit would occur one week after the final training session.&#xD;
  &#xD;
        This is a double-blind study in which participants will be randomly assigned to specific&#xD;
        intervention methods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Participants will be assigned to one of 4 groups: control, tDCS1, tDCS2, or tDCS3.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Participants and Research Assistants will be blinded to the groups/treatment conditions unless the participant is a &quot;control&quot;. The investigator and/or research administration team will screen, enroll and assign participants to groups.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Performance on motor task one week after final training session</measure>
      <time_frame>Change from Baseline to One-Week Follow Up visit (10 days)</time_frame>
      <description>This will be calculated as the average of two trials of the motor task that are completed one week after the last training session, after controlling for baseline. The motor task is a timed test that requires participants to spoon two beans (kidney, raw) at a time from a center proximal &quot;start&quot; cup to three distal &quot;target&quot; cups as fast as possible. In short, this task requires multijoint coordination and limb reversal, and performance for each trial is measured in seconds.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in motor performance over the course of training</measure>
      <time_frame>Three days</time_frame>
      <description>This outcome measure will be measured as the slope of the line fitted to the motor task performance across all 30 training trials, when trial is transformed to a logarithmic scale. This transformation is done to account for the fact that change in performance is non-linear. The motor task is a timed test that requires participants to spoon two beans (kidney, raw) at a time from a center proximal &quot;start&quot; cup to three distal &quot;target&quot; cups as fast as possible. In short, this task requires multijoint coordination and limb reversal, and performance for each trial is measured in seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in tDCS expectations from Day 1 to Day 7</measure>
      <time_frame>7 days</time_frame>
      <description>This will be the change (Day 1 minus Day 7) in expectations of tDCS. The tDCS expectation scores are taken from a 1-item survey adapted from the Expectation Assessment Scale, where scores range from 0 (no expectation) to 8 (high expectations); a score of 4 is considered neutral.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average dwell time</measure>
      <time_frame>10 days</time_frame>
      <description>This is the average amount of time spent in the home cup for each repetition, averaged across the two follow-up trials, controlling for baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average peak reach velocity</measure>
      <time_frame>10 days</time_frame>
      <description>his is the average peak velocity for the outward portion of each repetition, averaged across the two follow-up trials, controlling for baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in transcranial direct current stimulation expectations</measure>
      <time_frame>10 days</time_frame>
      <description>This is the coefficient of variation for tDCS expectation scores across the 4 study days (Days 1, 2, 3, and 10). The tDCS expectation scores are taken from a 1-item survey adapted from the Expectation Assessment Scale, where scores range from 0 (no expectation) to 8 (high expectations); a score of 4 is considered neutral.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-tDCS symptom questionnaire score</measure>
      <time_frame>10 days</time_frame>
      <description>This is calculated as the total number of points self-rated by the participant on a 14-item questionnaire with answers for each item ranging from 1 (&quot;absent&quot;) to 10 (&quot;severe&quot;).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">142</enrollment>
    <condition>Expectations</condition>
    <condition>Motor Learning</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will only receive motor training, which consists of 10 trials of motor training per day across 3 days, followed by a one-week follow-up of 2 trials.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>tDCS1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive motor training concurrent with 20 minutes of either sham or active tDCS. Sham tDCS will be a 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. The next 18 minutes will have no stimulation (0 mA), starting at minute 19 with 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. Active tDCS will ramp up to 2 mA in the first 30 seconds, then stay at 2 mA for 19 minutes, then ramp down to 0 mA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>tDCS2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will first read some information about tDCS based on cited studies. They will then receive the same motor training and tDCS as the tDCS1 arm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>tDCS3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will first read some information about tDCS based on cited studies, but different cited studies than the tDCS2 arm. They will then receive the same motor training and tDCS as the tDCS1 and 2 arms.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
      <description>Transcranial Direct Current Stimulation (tDCS) is a minimal risk, non-invasive, neuromodulatory technique that involves the emission of a weak electrical current, traditionally via the placement of two electrodes attached to the scalp of a participant. tDCS is widely used for research purposes, the US FDA considers trials of tDCS as non-significant-risk. There are several review articles supporting the safety of tDCS usage in controlled human trials. According to a published meta-analysis , the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions.</description>
      <arm_group_label>tDCS1</arm_group_label>
      <arm_group_label>tDCS2</arm_group_label>
      <arm_group_label>tDCS3</arm_group_label>
      <other_name>tDCS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must be 18 or older. Right-hand dominant&#xD;
  &#xD;
            -  Right-hand dominant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mixed-handed or ambidextrous&#xD;
  &#xD;
            -  Left-hand dominant&#xD;
  &#xD;
            -  Seizure(s)&#xD;
  &#xD;
            -  Head injury resulting in a loss of consciousness that has required further&#xD;
               investigation (including neurosurgery)&#xD;
  &#xD;
            -  Migraines&#xD;
  &#xD;
            -  Current medical diagnosis of a phycological or neurological condition&#xD;
  &#xD;
            -  Any metal in head (outside of mouth) such as shrapnel or surgical clips&#xD;
  &#xD;
            -  Any implanted devices (e.g. cardiac pacemaker, brain stimulator)&#xD;
  &#xD;
            -  Skin condition on scalp (e.g. psoriasis)&#xD;
  &#xD;
            -  Head wound that has not completely healed&#xD;
  &#xD;
            -  Adverse reactions to tDCS or any other brain stimulation technique (e.g. TMS, tRNS)&#xD;
  &#xD;
            -  Pregnant&#xD;
  &#xD;
            -  Currently taking prescription medications or are self-medicating (including&#xD;
               recreational drug use), other than the contraceptive pill?&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sydney Schaefer, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Arizona State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sydney Schaefer, PhD</last_name>
      <phone>480-727-6651</phone>
      <email>Sydney.Schaefer@asu.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>tDCS</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only aggregate data will be provided.</ipd_description>
    </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/NCT06039605
  org study id: STUDY00015655
  nct id: NCT06039605
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to test if priming expectations of transcranial Direct Current
        Stimulation (tDCS) can improve the efficacy of tDCS in enhancing motor learning.
  Transcranial direct current stimulation (tDCS) is currently being investigated by the
        scientific community as an intervention to improve motor learning in the context of
        neurorehabilitation (e.g., recover lost motor function after stroke) and performance
        enhancement (e.g., improve sports or technical skill training). More importantly, consumers
        believe that tDCS works. The expectation surrounding the benefits of tDCS for skill
        enhancement is so pervasive that the technology is sold for less than $200 and highly rated
        by the general public on Amazon.com. At the same time, there is considerable skepticism
        within the motor control field regarding the efficacy and mechanism of action of tDCS on
        motor learning, driven by highly irreproducible and equivocal findings between and even
        within laboratories.
  
        How effective is tDCS, and could the positive effects of tDCS be attributable in part to a
        strong placebo effect? Placebo effects (i.e., a positive expectation associated with positive
        treatment outcomes), are well documented in other interventions like surgeries and
        pharmaceuticals, but have not been investigated in detail for tDCS, particularly in the motor
        domain. The lack of knowledge or consideration of the placebo effect may therefore explain
        why tDCS findings are so inconsistent within motor learning. Thus, the overall aim of this
        project is to determine whether people's expectations about tDCS change as a function of
        information about tDCS itself, and whether these changed expectations modulate the effects of
        tDCS on motor learning.
  
        Transcranial direct current stimulation (tDCS) is a noninvasive, safe cortical stimulation
        technique that has been effectively used for enhancing and inhibiting sensory and motor
        performance when applied to the responsible cortical areas in healthy adults. For instance,
        anodal tDCS of primary motor area can improve motor execution. Recent research has
        investigated whether it is the expectation of receiving tDCS that has a greater impact on
        behavioral outcomes compared to the actual application of tDCS. This is important as many
        domains of science are challenged to reproduce previous research demonstrating a positive
        effect of tDCS on behavior. Thus, to decipher legitimate effects of tDCS on behavior it is
        important to quantify and compare how changes in behavior are related to tDCS, a key metric
        related to strength of the placebo effect, and how malleable these placebo effects are.
  
        Individuals may participate in this study for up to four sessions (up to 3 training sessions
        and up to 1 follow-up visit, as assigned) in the span of approximately one week. The
        investigators expect that individuals will spend up to one hour during the training sessions,
        and (if applicable) around 15 minutes to complete the follow-up visit, if assigned. The
        follow-up visit would occur one week after the final training session.
  
        This is a double-blind study in which participants will be randomly assigned to specific
        intervention methods.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be assigned to one of 4 groups: control, tDCS1, tDCS2, or tDCS3.
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: Participants and Research Assistants will be blinded to the groups/treatment conditions unless the participant is a "control". The investigator and/or research administration team will screen, enroll and assign participants to groups.
  measure: Performance on motor task one week after final training session
  time frame: Change from Baseline to One-Week Follow Up visit (10 days)
  description: This will be calculated as the average of two trials of the motor task that are completed one week after the last training session, after controlling for baseline. The motor task is a timed test that requires participants to spoon two beans (kidney, raw) at a time from a center proximal "start" cup to three distal "target" cups as fast as possible. In short, this task requires multijoint coordination and limb reversal, and performance for each trial is measured in seconds.
  measure: Change in motor performance over the course of training
  time frame: Three days
  description: This outcome measure will be measured as the slope of the line fitted to the motor task performance across all 30 training trials, when trial is transformed to a logarithmic scale. This transformation is done to account for the fact that change in performance is non-linear. The motor task is a timed test that requires participants to spoon two beans (kidney, raw) at a time from a center proximal "start" cup to three distal "target" cups as fast as possible. In short, this task requires multijoint coordination and limb reversal, and performance for each trial is measured in seconds.
  measure: Change in tDCS expectations from Day 1 to Day 7
  time frame: 7 days
  description: This will be the change (Day 1 minus Day 7) in expectations of tDCS. The tDCS expectation scores are taken from a 1-item survey adapted from the Expectation Assessment Scale, where scores range from 0 (no expectation) to 8 (high expectations); a score of 4 is considered neutral.
  measure: Average dwell time
  time frame: 10 days
  description: This is the average amount of time spent in the home cup for each repetition, averaged across the two follow-up trials, controlling for baseline.
  measure: Average peak reach velocity
  time frame: 10 days
  description: his is the average peak velocity for the outward portion of each repetition, averaged across the two follow-up trials, controlling for baseline.
  measure: Variability in transcranial direct current stimulation expectations
  time frame: 10 days
  description: This is the coefficient of variation for tDCS expectation scores across the 4 study days (Days 1, 2, 3, and 10). The tDCS expectation scores are taken from a 1-item survey adapted from the Expectation Assessment Scale, where scores range from 0 (no expectation) to 8 (high expectations); a score of 4 is considered neutral.
  measure: Post-tDCS symptom questionnaire score
  time frame: 10 days
  description: This is calculated as the total number of points self-rated by the participant on a 14-item questionnaire with answers for each item ranging from 1 ("absent") to 10 ("severe").
  arm group label: Control
  arm group type: No Intervention
  description: This group will only receive motor training, which consists of 10 trials of motor training per day across 3 days, followed by a one-week follow-up of 2 trials.
  arm group label: tDCS1
  arm group type: Experimental
  description: This group will receive motor training concurrent with 20 minutes of either sham or active tDCS. Sham tDCS will be a 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. The next 18 minutes will have no stimulation (0 mA), starting at minute 19 with 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. Active tDCS will ramp up to 2 mA in the first 30 seconds, then stay at 2 mA for 19 minutes, then ramp down to 0 mA.
  arm group label: tDCS2
  arm group type: Experimental
  description: This group will first read some information about tDCS based on cited studies. They will then receive the same motor training and tDCS as the tDCS1 arm.
  arm group label: tDCS3
  arm group type: Experimental
  description: This group will first read some information about tDCS based on cited studies, but different cited studies than the tDCS2 arm. They will then receive the same motor training and tDCS as the tDCS1 and 2 arms.
  intervention type: Device
  intervention name: Transcranial Direct Current Stimulation
  description: Transcranial Direct Current Stimulation (tDCS) is a minimal risk, non-invasive, neuromodulatory technique that involves the emission of a weak electrical current, traditionally via the placement of two electrodes attached to the scalp of a participant. tDCS is widely used for research purposes, the US FDA considers trials of tDCS as non-significant-risk. There are several review articles supporting the safety of tDCS usage in controlled human trials. According to a published meta-analysis , the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions.
  arm group label: tDCS1
  arm group label: tDCS2
  arm group label: tDCS3
  other name: tDCS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sydney Schaefer, PhD
  role: Principal Investigator
  affiliation: Arizona State University
  last name: Sydney Schaefer, PhD
  phone: 480-727-6651
  email: Sydney.Schaefer@asu.edu
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: Only aggregate data will be provided.