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Completed

NCT Number: NCT03083483

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.

Other names: Soterix

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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