Clinical trial NCT03083483: Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training
Official title: Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are randomized into SMA or bilateral M1 tDCS configurations. They are further randomized into active or sham tDCS.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Completion
timeFrame: 7 days
Secondary outcomes:
measure: Number of Tasks Completed
timeFrame: 7 days
measure: Number of Errors
timeFrame: 7 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Morgan L Cox, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Greg Appelbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox ML, Deng ZD, Palmer H, Watts A, Beynel L, Young JR, Lisanby SH, Migaly J, Appelbaum LG. Utilizing transcranial direct current stimulation to enhance laparoscopic technical skills training: A randomized controlled trial. Brain Stimul. 2020 May-Jun;13(3):863-872. doi: 10.1016/j.brs.2020.03.009. Epub 2020 Mar 19.