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Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03083483
Enrollment
71
Registered
2017-03-20
Start date
2017-04-01
Completion date
2017-12-21
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DEVICEtranscranial 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, 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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Completion7 daysCompletion 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

MeasureTime frameDescription
Number of Tasks Completed7 daysThe 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.
Number of Errors7 daysThe 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.

Countries

United States

Participant flow

Recruitment details

The recruitment period ran from 5/1/17 to 12/20/17. Subjects were recruited off of the Duke University Behavioral Research Lab Sessions Scheduling Website for undergraduate and graduate students, Duke School of Medicine students in the Trent Semans Center and Duke South Clinics, and Duke Pre-Medical undergraduate students.

Pre-assignment details

2 participants were screen failures

Participants by arm

ArmCount
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.
20
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.
20
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.
20
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event111
Overall StudyLost to Follow-up211
Overall Studytechnological issues101

Baseline characteristics

CharacteristicBilateral M1, Active tDCSTotalSham tDCSSMA, Active tDCS
Age, Continuous21.9 years
STANDARD_DEVIATION 5.2
22.7 years
STANDARD_DEVIATION 4.8
22.7 years
STANDARD_DEVIATION 3.7
23.5 years
STANDARD_DEVIATION 5.4
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants7 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants53 Participants18 Participants17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
9 Participants20 Participants5 Participants6 Participants
Race (NIH/OMB)
Black or African American
3 Participants9 Participants4 Participants2 Participants
Race (NIH/OMB)
More than one race
1 Participants4 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
White
6 Participants24 Participants8 Participants10 Participants
Region of Enrollment
United States
20 participants60 participants20 participants20 participants
Sex: Female, Male
Female
12 Participants42 Participants14 Participants16 Participants
Sex: Female, Male
Male
8 Participants18 Participants6 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 210 / 21
other
Total, other adverse events
1 / 211 / 211 / 21
serious
Total, serious adverse events
0 / 210 / 210 / 21

Outcome results

Primary

Time to Completion

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)

Time frame: 7 days

Population: Participants who completed the study.

ArmMeasureValue (MEAN)Dispersion
Bilateral M1, Active tDCSTime to Completion55.3 seconds to completion in post testStandard Deviation 15.4
SMA, Active tDCSTime to Completion54.5 seconds to completion in post testStandard Deviation 13.1
Sham tDCSTime to Completion59.5 seconds to completion in post testStandard Deviation 18.3
Secondary

Number of Errors

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.

Time frame: 7 days

Population: Participants who completed the study.

ArmMeasureGroupValue (MEAN)Dispersion
Bilateral M1, Active tDCSNumber of ErrorsImproper Transfers- Session 50.8 errorsStandard Deviation 2.6
Bilateral M1, Active tDCSNumber of ErrorsDrops out of view- Session 51.3 errorsStandard Deviation 1.4
Bilateral M1, Active tDCSNumber of ErrorsImproper Transfers- Session 40.7 errorsStandard Deviation 1.3
Bilateral M1, Active tDCSNumber of ErrorsDrops out of view- Session 21.5 errorsStandard Deviation 1.4
Bilateral M1, Active tDCSNumber of ErrorsDrops out of view- Session 61.0 errorsStandard Deviation 1.1
Bilateral M1, Active tDCSNumber of ErrorsImproper Transfers- Session 62.0 errorsStandard Deviation 5.8
Bilateral M1, Active tDCSNumber of ErrorsImproper Transfers- Session 31.1 errorsStandard Deviation 2.1
Bilateral M1, Active tDCSNumber of ErrorsImproper Transfers- Session 13.8 errorsStandard Deviation 12.9
Bilateral M1, Active tDCSNumber of ErrorsDrops out of view- Session 41.7 errorsStandard Deviation 2
Bilateral M1, Active tDCSNumber of ErrorsDrops out of view- session 11.3 errorsStandard Deviation 1.6
Bilateral M1, Active tDCSNumber of ErrorsImproper Transfers- Session 24.8 errorsStandard Deviation 14
Bilateral M1, Active tDCSNumber of ErrorsDrops out of view- Session 31.2 errorsStandard Deviation 1.2
SMA, Active tDCSNumber of ErrorsImproper Transfers- Session 21.5 errorsStandard Deviation 2.4
SMA, Active tDCSNumber of ErrorsImproper Transfers- Session 31.0 errorsStandard Deviation 1.6
SMA, Active tDCSNumber of ErrorsDrops out of view- session 11.4 errorsStandard Deviation 1.6
SMA, Active tDCSNumber of ErrorsImproper Transfers- Session 41.0 errorsStandard Deviation 1.5
SMA, Active tDCSNumber of ErrorsImproper Transfers- Session 50.7 errorsStandard Deviation 0.9
SMA, Active tDCSNumber of ErrorsImproper Transfers- Session 60.7 errorsStandard Deviation 0.9
SMA, Active tDCSNumber of ErrorsDrops out of view- Session 40.8 errorsStandard Deviation 0.9
SMA, Active tDCSNumber of ErrorsDrops out of view- Session 31.8 errorsStandard Deviation 1.3
SMA, Active tDCSNumber of ErrorsDrops out of view- Session 51.8 errorsStandard Deviation 1.9
SMA, Active tDCSNumber of ErrorsDrops out of view- Session 61.2 errorsStandard Deviation 1.4
SMA, Active tDCSNumber of ErrorsDrops out of view- Session 21.6 errorsStandard Deviation 1.7
SMA, Active tDCSNumber of ErrorsImproper Transfers- Session 13.1 errorsStandard Deviation 6.6
Sham tDCSNumber of ErrorsImproper Transfers- Session 61.1 errorsStandard Deviation 2.2
Sham tDCSNumber of ErrorsDrops out of view- session 11.2 errorsStandard Deviation 1.2
Sham tDCSNumber of ErrorsDrops out of view- Session 21.5 errorsStandard Deviation 1.7
Sham tDCSNumber of ErrorsDrops out of view- Session 31.3 errorsStandard Deviation 1.7
Sham tDCSNumber of ErrorsDrops out of view- Session 41.2 errorsStandard Deviation 1.3
Sham tDCSNumber of ErrorsDrops out of view- Session 51.7 errorsStandard Deviation 0.7
Sham tDCSNumber of ErrorsDrops out of view- Session 61.0 errorsStandard Deviation 1.7
Sham tDCSNumber of ErrorsImproper Transfers- Session 12.2 errorsStandard Deviation 3.3
Sham tDCSNumber of ErrorsImproper Transfers- Session 21.2 errorsStandard Deviation 2.2
Sham tDCSNumber of ErrorsImproper Transfers- Session 30.7 errorsStandard Deviation 1.4
Sham tDCSNumber of ErrorsImproper Transfers- Session 41.4 errorsStandard Deviation 3
Sham tDCSNumber of ErrorsImproper Transfers- Session 51.0 errorsStandard Deviation 2.4
Secondary

Number of Tasks Completed

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.

Time frame: 7 days

Population: In performing the study, only FLS task 1 was performed and evaluated. Therefore, no data was collected or analyzed on multiple tasks.

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026