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Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

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ClinicalTrials.gov Identifier: NCT03083483
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to test the influences of transcranial direct current stimulation (tDCS) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of tDCS in the first of 2 experiments. The second arm of the trial will investigate gaze training in a similar study design. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: transcranial direct current stimulation (tDCS) Not Applicable

Detailed Description:

Developing expert performance requires assessment of the thought processes underlying performance and continued refinement of skills in order to obtain automaticity and intuition. Therefore, developing expert surgical skill is a process likely to take longer than the length of residency, thereby diminishing the quality of care delivered to patients.

The proposed study will implement novel neuroscience techniques of transcranial direct current stimulation to determine if it has the capacity to accelerate technical surgical skill learning in order to achieve competency and expertise in an earlier timeframe. tDCS is a non-invasive brain stimulation technique that delivers constant, low current stimulation via electrodes placed on the scalp to modify cortical excitability in an area of interest. When applied to the motor cortex, promising data indicates that tDCS-induced changes lead to expedited recovery in stroke patients as well as enhanced learning in healthy individuals.

This technique has never been applied in the training of surgical residents making this project an innovative approach to enhance skill development.

Experiment 1: Determine if tDCS can accelerate the learning of laparoscopic skills.

In this experiment the investigators will compare behavioral learning curves from FLS modules 1 and 5 in three cohorts who undergo either active tDCS to the bilateral motor cortex (bilateral configuration), active tDCS to the supplementary motor cortex (SMA configuration), or sham tDCS (half in each configuration). This will be tested in groups of 20 participants who train for 40-minutes in each of 6 sessions that occur within 3 weeks. The investigators hypothesize that both active bilateral and SMA tDCS will lead to faster skill acquisition as measured by trials required to gain proficient completion scores (calculated as time plus errors), relative to sham.

The investigators hypothesize that both bilateral and vertex tDCS will lead to faster skill acquisition, with bilateral greater than vertex as measured by trials required to gain proficient module completion scores, relative to the group of participants who practice without active tDCS.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are randomized into SMA or bilateral M1 tDCS configurations. They are further randomized into active or sham tDCS.
Masking: Double (Participant, Investigator)
Masking Description: For the tDCS portion of the protocol, the subject and investigator will be blinded to active vs sham. The configuration and order of FLS tasks will be known to both.
Primary Purpose: Other
Official Title: Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Arm Intervention/treatment
Experimental: Bilateral M1, active tDCS
Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side.
Device: transcranial direct current stimulation (tDCS)
tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.
Other Name: Soterix

Experimental: SMA, active tDCS
Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex.
Device: transcranial direct current stimulation (tDCS)
tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.
Other Name: Soterix

Sham Comparator: sham tDCS
Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation. Half of these subjects will be placed in the SMA configuration and the other half in the bilateral M1 electrode configuration.
Device: transcranial direct current stimulation (tDCS)
tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.
Other Name: Soterix




Primary Outcome Measures :
  1. Time to Completion [ Time Frame: 7 days ]
    Completion time for each repetition of Fundamentals of Laparoscopic Surgery (FLS) task 1 in post-test (1 single repetition of the task that was timed after all training was completed)


Secondary Outcome Measures :
  1. Number of Tasks Completed [ Time Frame: 7 days ]
    The number of completed tasks will be calculated during retrospective review of recorded video through study completion. The six training sessions for data collection will be completed within a 7-day span.

  2. Number of Errors [ Time Frame: 7 days ]
    The number of errors (as defined by FLS) during completion of tasks will be recorded and transitioned into a time addition. This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period. These errors will be defined and retrospective review of recorded video through study completion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age >18 years, healthy male and female
  2. Negative urine pregnancy test for female participants
  3. Willing and able to provide informed consent
  4. Able to follow study procedures

Exclusion Criteria:

  1. Indwelling metallic implants
  2. Neurological or psychiatric medical history
  3. Drug or alcohol abuse
  4. Current or prior brain tumor
  5. Current or prior seizures
  6. Neuroactive medications
  7. Current pregnancy
  8. Damage, rash, or skin lesion in area of electrode placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083483


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Morgan L Cox, MD Duke University
Principal Investigator: Greg Appelbaum, PhD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03083483     History of Changes
Other Study ID Numbers: Pro00078782
First Posted: March 20, 2017    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No