NCT03083483

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Completed NA Results posted Last updated 6 January 2020

What this trial tests

NA trial testing transcranial direct current stimulation (tDCS) in Healthy Volunteers in 71 participants. Completed in 21 December 2017.

Timeline

1 April 2017

Primary endpoint
21 December 2017

21 December 2017

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	71
Start date	1 April 2017
Primary completion	21 December 2017
Estimated completion	21 December 2017
Sites	1 location across United States

Drugs / interventions tested

• transcranial direct current stimulation (tDCS)

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Duke University

Who can join

18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Completion Primary · 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)

Group	Value	95% CI
Bilateral M1, Active tDCS	55.3	± 15.4
SMA, Active tDCS	54.5	± 13.1
Sham tDCS	59.5	± 18.3

Number of Errors Secondary · 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.

Drops out of view- session 1

Group	Value	95% CI
Bilateral M1, Active tDCS	1.3	± 1.6
SMA, Active tDCS	1.4	± 1.6
Sham tDCS	1.2	± 1.2

Drops out of view- Session 2

Group	Value	95% CI
Bilateral M1, Active tDCS	1.5	± 1.4
SMA, Active tDCS	1.6	± 1.7
Sham tDCS	1.5	± 1.7

Drops out of view- Session 3

Group	Value	95% CI
Bilateral M1, Active tDCS	1.2	± 1.2
SMA, Active tDCS	1.8	± 1.3
Sham tDCS	1.3	± 1.7

Drops out of view- Session 4

Group	Value	95% CI
Bilateral M1, Active tDCS	1.7	± 2.0
SMA, Active tDCS	0.8	± 0.9
Sham tDCS	1.2	± 1.3

Drops out of view- Session 5

Group	Value	95% CI
Bilateral M1, Active tDCS	1.3	± 1.4
SMA, Active tDCS	1.8	± 1.9
Sham tDCS	1.7	± 0.7

Drops out of view- Session 6

Group	Value	95% CI
Bilateral M1, Active tDCS	1.0	± 1.1
SMA, Active tDCS	1.2	± 1.4
Sham tDCS	1.0	± 1.7

Improper Transfers- Session 1

Group	Value	95% CI
Bilateral M1, Active tDCS	3.8	± 12.9
SMA, Active tDCS	3.1	± 6.6
Sham tDCS	2.2	± 3.3

Improper Transfers- Session 2

Group	Value	95% CI
Bilateral M1, Active tDCS	4.8	± 14
SMA, Active tDCS	1.5	± 2.4
Sham tDCS	1.2	± 2.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bilateral M1, Active tDCS

Serious: 0/21 (0%)

Deaths: 0/21

SMA, Active tDCS

Serious: 0/21 (0%)

Deaths: 0/21

Sham tDCS

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (1 terms — click to expand)

Reaction	System	Bilateral M1, Active tDCS	SMA, Active tDCS	Sham tDCS
Lightheadedness	Injury, poisoning and procedural complications	—	—	—

Data from ClinicalTrials.gov NCT03083483 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Utilizing transcranial direct current stimulation to enhance laparoscopic technical skills training: A randomized controlled trial.
   Cox ML, Deng ZD, Palmer H, Watts A, et al · · 2020 · cited 25× · PMID 32289719 · DOI 10.1016/j.brs.2020.03.009