Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Healthy Volunteers Clinical Trial

Official title:

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083483
• Other study ID #: Pro00078782
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 21, 2017

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	7 days
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.	7 days
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.	7 days