Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

NCT03083483 | Completed Results FDA Device

• 1 other identifier: Pro00078782
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Tasks Completed

  7 days

• Number of Errors

  7 days

Study Arms (3)

Bilateral M1, active tDCS

EXPERIMENTAL

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.

Device: transcranial direct current stimulation (tDCS)

SMA, active tDCS

EXPERIMENTAL

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.

Device: transcranial direct current stimulation (tDCS)

sham tDCS

SHAM COMPARATOR

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. Half of these subjects will be placed in the SMA configuration and the other half in the bilateral M1 electrode configuration.

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.

Also known as: Soterix

Bilateral M1, active tDCS; SMA, active tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 32289719 DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Hannah Palmer
• Organization: Duke University

hlp14@duke.edu

919-613-7665

Study Officials

• Morgan L Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Greg Appelbaum, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: April 1, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: January 6, 2020
• Results First Posted: November 14, 2018

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)