<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/NCT02987816</url>
  </required_header>
  <id_info>
    <org_study_id>REB 15-2443</org_study_id>
    <nct_id>NCT02987816</nct_id>
  </id_info>
  <brief_title>Neurosurgical Skill Enhancement Using Transcranial Stimulation</brief_title>
  <acronym>LETS-LEARN</acronym>
  <official_title>Learning Enhancement Using Transcranial Stimulation, Leading Expertise, Acquisition and Retention of Neurosurgical Skills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent changes in medical training environments and restrictive work-hour regulations have&#xD;
      greatly impacted trainees, limiting the number of opportunities to gain proficiency in&#xD;
      procedural skills. Reports suggest that medical residents lack confidence in their ability to&#xD;
      perform certain medical procedures, and program directors often do not believe their&#xD;
      residents can operate independently in major procedures. Simulator based task training (SBTT)&#xD;
      has provided a safe and ethically appropriate method of skill acquisition but training&#xD;
      opportunities remain limited. Methods to enhance motor learning during these training&#xD;
      opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an&#xD;
      emerging form of non-invasive brain stimulation that has been shown to improve motor&#xD;
      learning. tDCS has been shown to enhance increasingly complex skill acquisition. The&#xD;
      investigators propose to examine if tDCS can improve the acquisition and retention of&#xD;
      neurosurgical skill. The investigators propose a double blind, sham-controlled randomized&#xD;
      trial applying tDCS during evidence-based SBTT of medical students, to determine if brain&#xD;
      stimulation can enhance training skill acquisition and retention. Even a modest enhancement&#xD;
      carries the potential to transform medicosurgical skills training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Recent changes in medical training environments have resulted in many trainees&#xD;
      lacking sufficient opportunity to acquire specific skills necessary for their specialty. New&#xD;
      methods to enhance the acquisition and retention of medical and surgical skills are required&#xD;
      to ensure the quality of the future physician workforce. Transcranial direct-current&#xD;
      stimulation (tDCS) is an emerging method of non-invasive brain stimulation that has been show&#xD;
      to safely enhance motor learning in adults and children. Even a modest enhancement of&#xD;
      acquisition and retention of medical-surgical skill with tDCS carries the potential to&#xD;
      accelerate skill training for health care providers, thereby contributing to greater training&#xD;
      efficiency and improved patient outcomes.&#xD;
&#xD;
      Objectives: The objective of this study is to assess whether tDCS can enhance the acquisition&#xD;
      and retention of neurosurgical ability.&#xD;
&#xD;
      Ethics:This study has been approval by the University of Calgary Research Ethics Board&#xD;
&#xD;
      Design: Randomized, double blind, sham-controlled trial to evaluate the ability of tDCS to&#xD;
      enhance learning and retention of neurosurgical skills.&#xD;
&#xD;
      Transcranial Direct-Current Stimulation: The tDCS methods used are based on best-available&#xD;
      evidence and practices, and will be applied in a standardized fashion by experienced&#xD;
      investigators. Anodal tDCS will be delivered through saline-soaked sponge electrodes using a&#xD;
      NeuroConn Direct-Current Stimulator (NeuroConn, Ilmenau, Germany). The anode will be centered&#xD;
      over the left primary motor cortex (localized using the 10-20 EEG System), with the cathode&#xD;
      over the contralateral supraorbital area. Both anodal and sham tDCS groups will have the&#xD;
      current ramped-up to 1milliamp over 30 seconds. In the anodal tDCS group, the current will be&#xD;
      held for 20 minutes. In the sham tDCS condition, the current will be held for only 60 seconds&#xD;
      (no changes in cortical excitability) followed by a 30 second ramp-down.&#xD;
&#xD;
      Participants: Medical students (years 1-3) from the Cumming School of Medicine (University of&#xD;
      Calgary) will be recruited. To ensure comparable baseline skills, trainees will be excluded&#xD;
      if they have undergone formal neurosurgical training in the past 3 months.&#xD;
&#xD;
      Sample size calculations are based on the performance measures for the percentage of virtual&#xD;
      tumor resected, determined through pilot studies. Based on 20% more tumor being resected at&#xD;
      post-training, power of 90% and type-1 error of 0.05, the investigators estimate a sample&#xD;
      size of a minimum of 24 participants (n=12 per stimulation condition).&#xD;
&#xD;
      Study Design: A short questionnaire will be completed to determine demographic&#xD;
      characteristics, including: gender, age, level of training, how many times participants have&#xD;
      performed on a virtual surgical simulator, how often participants play video games, and how&#xD;
      often participants play a musical instrument.&#xD;
&#xD;
      Participants will be recruited at the Project NeuroArm Laboratory (University of Calgary) and&#xD;
      be oriented to the workspace. Participants will complete virtual tumor resections on a&#xD;
      NeuroTouch (National Research Council of Canada) surgical simulator. Participants will view a&#xD;
      standardized training video, created by an expert in neurosurgery, demonstrating a virtual&#xD;
      tumor resection using the simulator. Participant will have 3 minutes to resect a virtual&#xD;
      tumor, avoiding resection of healthy tissue. Recorded outcome metrics will include: % tumor&#xD;
      resected, volume of healthy tissue resected, time of excessive force on tumor and time of&#xD;
      excessive force on healthy tissue.&#xD;
&#xD;
      Participants will perform one resection at baseline, establishing baseline skill.&#xD;
      Participants will be randomized to receive sham or active tDCS by blinding selecting a code&#xD;
      from the envelope, corresponding to a particular stimulation condition. Participants will&#xD;
      perform eight training repetitions, taking approximately 30 minutes. Following approximately&#xD;
      30 minutes of training (eight training repetitions) the tDCS electrodes will be removed, and&#xD;
      a final resection will be performed. Six weeks following the training the participants will&#xD;
      return to assess retention of skill, performing a single resection. Emerging evidence&#xD;
      suggests that a significant decay in surgical skill is present six weeks following training.&#xD;
&#xD;
      Data Analysis: Independent samples t-test will evaluate difference in outcome metrics at&#xD;
      post-training between stimulation conditions. Two-way repeated-measures ANOVA for factors&#xD;
      &quot;stimulation type&quot; and &quot;training block&quot; will explore the interaction between tDCS and&#xD;
      training for each outcome metric. Retention of skill will be assessed using a paired t-test&#xD;
      for each stimulation group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in % tumor resected</measure>
    <time_frame>Baseline and immediately post-training</time_frame>
    <description>A &quot;baseline&quot; trial will be performed, followed by 8 consecutive &quot;training&quot; trials (approximately 30 minutes of training), immediately followed by a &quot;post-training&quot; trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in volume of healthy tissue resected</measure>
    <time_frame>Baseline and immediately post-training</time_frame>
    <description>A &quot;baseline&quot; trial will be performed, followed by 8 consecutive &quot;training&quot; trials (approximately 30 minutes of training), immediately followed by a &quot;post-training&quot; trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time of excessive forces on tumor</measure>
    <time_frame>Baseline and immediately post-training</time_frame>
    <description>A &quot;baseline&quot; trial will be performed, followed by 8 consecutive &quot;training&quot; trials (approximately 30 minutes of training), immediately followed by a &quot;post-training&quot; trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time of excessive forces on healthy tissue</measure>
    <time_frame>Baseline and immediately post-training</time_frame>
    <description>A &quot;baseline&quot; trial will be performed, followed by 8 consecutive &quot;training&quot; trials (approximately 30 minutes of training), immediately followed by a &quot;post-training&quot; trial.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Retention of primary and secondary outcomes measures</measure>
    <time_frame>6 weeks following training</time_frame>
    <description>Retention of skill will be examined 6 weeks following the training session. A single repetition of the tumor resection task will be performed. % tumor resected, volume of healthy tissue resected, time of excessive forces on tumor, and time of excessive forces on healthy tissue will be recorded and compared to the &quot;post-training&quot; trial (immediately following training).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Neurosurgery</condition>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS. 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anodal tDCS. 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.</description>
    <arm_group_label>Sham tDCS</arm_group_label>
    <other_name>Sham transcranial direct current stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal tDCS</intervention_name>
    <description>NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.</description>
    <arm_group_label>Anodal tDCS</arm_group_label>
    <other_name>Anodal transcranial direct current stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical student&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a developmental, neurological or neuropsychiatric disorder&#xD;
&#xD;
          -  Taking neuropsychotropic medication&#xD;
&#xD;
          -  Has an irremovable implanted metal object in the head&#xD;
&#xD;
          -  Has a pacemaker or other implanted electrical device&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Coleman JJ, Esposito TJ, Rozycki GS, Feliciano DV. Early subspecialization and perceived competence in surgical training: are residents ready? J Am Coll Surg. 2013 Apr;216(4):764-71; discussion 771-3. doi: 10.1016/j.jamcollsurg.2012.12.045.</citation>
    <PMID>23521960</PMID>
  </reference>
  <reference>
    <citation>Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.</citation>
    <PMID>10990547</PMID>
  </reference>
  <reference>
    <citation>Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.</citation>
    <PMID>21968548</PMID>
  </reference>
  <reference>
    <citation>Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.</citation>
    <PMID>19164589</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Patrick Ciechanski</investigator_full_name>
    <investigator_title>PhD Candidate (Neurosciences)</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987816
org study id: REB 15-2443
nct id: NCT02987816
lead sponsor: 
has dmc: No
Recent changes in medical training environments and restrictive work-hour regulations have
      greatly impacted trainees, limiting the number of opportunities to gain proficiency in
      procedural skills. Reports suggest that medical residents lack confidence in their ability to
      perform certain medical procedures, and program directors often do not believe their
      residents can operate independently in major procedures. Simulator based task training (SBTT)
      has provided a safe and ethically appropriate method of skill acquisition but training
      opportunities remain limited. Methods to enhance motor learning during these training
      opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an
      emerging form of non-invasive brain stimulation that has been shown to improve motor
      learning. tDCS has been shown to enhance increasingly complex skill acquisition. The
      investigators propose to examine if tDCS can improve the acquisition and retention of
      neurosurgical skill. The investigators propose a double blind, sham-controlled randomized
      trial applying tDCS during evidence-based SBTT of medical students, to determine if brain
      stimulation can enhance training skill acquisition and retention. Even a modest enhancement
      carries the potential to transform medicosurgical skills training.
Rationale: Recent changes in medical training environments have resulted in many trainees
      lacking sufficient opportunity to acquire specific skills necessary for their specialty. New
      methods to enhance the acquisition and retention of medical and surgical skills are required
      to ensure the quality of the future physician workforce. Transcranial direct-current
      stimulation (tDCS) is an emerging method of non-invasive brain stimulation that has been show
      to safely enhance motor learning in adults and children. Even a modest enhancement of
      acquisition and retention of medical-surgical skill with tDCS carries the potential to
      accelerate skill training for health care providers, thereby contributing to greater training
      efficiency and improved patient outcomes.

      Objectives: The objective of this study is to assess whether tDCS can enhance the acquisition
      and retention of neurosurgical ability.

      Ethics:This study has been approval by the University of Calgary Research Ethics Board

      Design: Randomized, double blind, sham-controlled trial to evaluate the ability of tDCS to
      enhance learning and retention of neurosurgical skills.

      Transcranial Direct-Current Stimulation: The tDCS methods used are based on best-available
      evidence and practices, and will be applied in a standardized fashion by experienced
      investigators. Anodal tDCS will be delivered through saline-soaked sponge electrodes using a
      NeuroConn Direct-Current Stimulator (NeuroConn, Ilmenau, Germany). The anode will be centered
      over the left primary motor cortex (localized using the 10-20 EEG System), with the cathode
      over the contralateral supraorbital area. Both anodal and sham tDCS groups will have the
      current ramped-up to 1milliamp over 30 seconds. In the anodal tDCS group, the current will be
      held for 20 minutes. In the sham tDCS condition, the current will be held for only 60 seconds
      (no changes in cortical excitability) followed by a 30 second ramp-down.

      Participants: Medical students (years 1-3) from the Cumming School of Medicine (University of
      Calgary) will be recruited. To ensure comparable baseline skills, trainees will be excluded
      if they have undergone formal neurosurgical training in the past 3 months.

      Sample size calculations are based on the performance measures for the percentage of virtual
      tumor resected, determined through pilot studies. Based on 20% more tumor being resected at
      post-training, power of 90% and type-1 error of 0.05, the investigators estimate a sample
      size of a minimum of 24 participants (n=12 per stimulation condition).

      Study Design: A short questionnaire will be completed to determine demographic
      characteristics, including: gender, age, level of training, how many times participants have
      performed on a virtual surgical simulator, how often participants play video games, and how
      often participants play a musical instrument.

      Participants will be recruited at the Project NeuroArm Laboratory (University of Calgary) and
      be oriented to the workspace. Participants will complete virtual tumor resections on a
      NeuroTouch (National Research Council of Canada) surgical simulator. Participants will view a
      standardized training video, created by an expert in neurosurgery, demonstrating a virtual
      tumor resection using the simulator. Participant will have 3 minutes to resect a virtual
      tumor, avoiding resection of healthy tissue. Recorded outcome metrics will include: % tumor
      resected, volume of healthy tissue resected, time of excessive force on tumor and time of
      excessive force on healthy tissue.

      Participants will perform one resection at baseline, establishing baseline skill.
      Participants will be randomized to receive sham or active tDCS by blinding selecting a code
      from the envelope, corresponding to a particular stimulation condition. Participants will
      perform eight training repetitions, taking approximately 30 minutes. Following approximately
      30 minutes of training (eight training repetitions) the tDCS electrodes will be removed, and
      a final resection will be performed. Six weeks following the training the participants will
      return to assess retention of skill, performing a single resection. Emerging evidence
      suggests that a significant decay in surgical skill is present six weeks following training.

      Data Analysis: Independent samples t-test will evaluate difference in outcome metrics at
      post-training between stimulation conditions. Two-way repeated-measures ANOVA for factors
      "stimulation type" and "training block" will explore the interaction between tDCS and
      training for each outcome metric. Retention of skill will be assessed using a paired t-test
      for each stimulation group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Change in % tumor resected
time frame: Baseline and immediately post-training
description: A "baseline" trial will be performed, followed by 8 consecutive "training" trials (approximately 30 minutes of training), immediately followed by a "post-training" trial.
measure: Change in volume of healthy tissue resected
time frame: Baseline and immediately post-training
description: A "baseline" trial will be performed, followed by 8 consecutive "training" trials (approximately 30 minutes of training), immediately followed by a "post-training" trial.
measure: Change in time of excessive forces on tumor
time frame: Baseline and immediately post-training
description: A "baseline" trial will be performed, followed by 8 consecutive "training" trials (approximately 30 minutes of training), immediately followed by a "post-training" trial.
measure: Change in time of excessive forces on healthy tissue
time frame: Baseline and immediately post-training
description: A "baseline" trial will be performed, followed by 8 consecutive "training" trials (approximately 30 minutes of training), immediately followed by a "post-training" trial.
measure: Retention of primary and secondary outcomes measures
time frame: 6 weeks following training
description: Retention of skill will be examined 6 weeks following the training session. A single repetition of the tumor resection task will be performed. % tumor resected, volume of healthy tissue resected, time of excessive forces on tumor, and time of excessive forces on healthy tissue will be recorded and compared to the "post-training" trial (immediately following training).
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Sham tDCS. 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.
arm group label: Anodal tDCS
arm group type: Experimental
description: Anodal tDCS. 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.
intervention type: Device
intervention name: Sham tDCS
description: NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.
arm group label: Sham tDCS
other name: Sham transcranial direct current stimulation
intervention type: Device
intervention name: Anodal tDCS
description: NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.
arm group label: Anodal tDCS
other name: Anodal transcranial direct current stimulation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Coleman JJ, Esposito TJ, Rozycki GS, Feliciano DV. Early subspecialization and perceived competence in surgical training: are residents ready? J Am Coll Surg. 2013 Apr;216(4):764-71; discussion 771-3. doi: 10.1016/j.jamcollsurg.2012.12.045.
PMID: 23521960
citation: Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PMID: 10990547
citation: Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.
PMID: 21968548
citation: Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.
PMID: 19164589
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Patrick Ciechanski
investigator title: PhD Candidate (Neurosciences)
sharing ipd: No