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Clinical Trials/NCT03083483
NCT03083483
Completed
N/A

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Duke University1 site in 1 country71 target enrollmentApril 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Duke University
Enrollment
71
Locations
1
Primary Endpoint
Time to Completion
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
December 21, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \>18 years, healthy male and female
  • Negative urine pregnancy test for female participants
  • Willing and able to provide informed consent
  • Able to follow study procedures

Exclusion Criteria

  • Indwelling metallic implants
  • Neurological or psychiatric medical history
  • Drug or alcohol abuse
  • Current or prior brain tumor
  • Current or prior seizures
  • Neuroactive medications
  • Current pregnancy
  • Damage, rash, or skin lesion in area of electrode placement

Outcomes

Primary Outcomes

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 Outcomes

  • Number of Tasks Completed(7 days)
  • Number of Errors(7 days)

Study Sites (1)

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