N/A N=69 Randomized Double-blind Other

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT03083483 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Time to Completion — 55.3; 54.5; 59.5 seconds to completion in post test

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: transcranial direct current stimulation (tDCS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Completion	55.3; 54.5; 59.5	—
SECONDARY Number of Tasks Completed	—	—
SECONDARY Number of Errors	1.3; 1.4; 1.2; 1.5; 1.6; 1.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03083483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.