Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-12-21

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects are randomized into SMA or bilateral M1 tDCS configurations. They are further randomized into active or sham tDCS.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Soterix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes