Enhancing Laparoscopic Skill Acquisition and Retention With Transcranial Direct-current Stimulation

NCT02756052 | Completed

• 1 other identifier: REB15-2443
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Recent changes in medical training environments and restrictive work-hour regulations have greatly impacted trainees, limiting the number of opportunities to gain proficiency in procedural skills. Reports suggest that medical residents lack confidence in their ability to perform certain medical procedures, and program directors often do not believe their residents can operate independently in major procedures. Simulator based task training (SBTT) has provided a safe and ethically appropriate method of skill acquisition but training opportunities remain limited. Methods to enhance motor learning during these training opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an emerging form of non-invasive brain stimulation that has been shown to improve motor learning. tDCS has been shown to enhance increasingly complex skill acquisition. The investigators propose to examine if tDCS can improve the acquisition and retention of laparoscopic surgical skill. The investigators propose a double blind, sham-controlled randomized trial applying tDCS during evidence-based SBTT of medical students and surgical residents, to determine if brain stimulation can enhance training effects and long-term skill acquisition. Even a modest enhancement carries the potential to transform medicosurgical skills training.

Conditions

Laparoscopic Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• Change in Fundamentals of Laparoscopic Surgery pattern cutting task total score

  A "baseline trial" will be performed, followed by 8 consecutive "training trials", immediately followed by a "post-training trial". A total score is calculated by subtracting the error score from the time score. A time score will be calculated by subtracting the completion time in seconds from the task cut-off time of 300 seconds. An error score will be calculated as the percentage area deviation of cutting a perfect circle.

  Baseline and Immediately Post-Training

• Change in Fundamentals of Laparoscopic Surgery peg transfer task total score

  A "baseline trial" will be performed, followed by 8 consecutive "training trials", immediately followed by a "post-training trial". A total score is calculated by subtracting the error score from the time score. A time score will be calculated by subtracting the completion time in seconds from the task cut-off time of 300 seconds. An error score will be calculated as the percentage of pegs that could not be transferred due to being dropped outside of the field of view (i.e. 1 of 6 pegs lost = 17 second penalty).

  Baseline and Immediately Post-Training

Secondary Outcomes (2)

• Retention of Fundamentals of Laparoscopic Surgery pattern cutting task total score

  6 Weeks following Training

• Retention of Fundamentals of Laparoscopic Surgery peg transfer task total score

  6 Weeks following Training

Other Outcomes (2)

• Change in Purdue Pegboard Test score

  Baseline and Immediately Post-Training

• Visual Analog Scale for tDCS-sensations

  Baseline and Immediately Post-Training

Study Arms (4)

Medical Student - Sham tDCS

SHAM COMPARATOR

Participants: 1st to 3rd year medical students from the Cumming School of Medicine (University of Calgary). Device: Sham tDCS. 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Device: Sham Transcranial direct-current stimulation

General Surgery Resident - Sham tDCS

SHAM COMPARATOR

Participants: 1st to 5th year general surgery residents from the Cumming School of Medicine (University of Calgary). Device: Sham tDCS. 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Device: Sham Transcranial direct-current stimulation

Medical Student - Anodal tDCS

EXPERIMENTAL

Participants: 1st to 3rd year medical students from the Cumming School of Medicine (University of Calgary). Device: Anodal tDCS. 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Device: Anodal Transcranial direct-current stimulation

General Surgery Resident - Anodal tDCS

EXPERIMENTAL

Participants: 1st to 5th year general surgery residents from the Cumming School of Medicine (University of Calgary). Device: Anodal tDCS. 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Device: Anodal Transcranial direct-current stimulation

Interventions

Anodal Transcranial direct-current stimulation DEVICE

NeuroConn Direct-Current Stimulator. Anodal tDCS: 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Also known as: Anodal tDCS

General Surgery Resident - Anodal tDCS; Medical Student - Anodal tDCS

Sham Transcranial direct-current stimulation DEVICE

NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Also known as: Sham tDCS

General Surgery Resident - Sham tDCS; Medical Student - Sham tDCS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical student or general surgery residents
• Informed consent

You may not qualify if:

• Diagnosis of a developmental, neurological or neuropsychiatric disorder
• Taking neuropsychotropic medication
• Has an irremovable implanted metal object in the head
• Has a pacemaker or other implanted electrical device
• Pregnant

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Cumming School of Medicine

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (8)

• Lewis FR, Klingensmith ME. Issues in general surgery residency training--2012. Ann Surg. 2012 Oct;256(4):553-9. doi: 10.1097/SLA.0b013e31826bf98c. No abstract available.

  PMID: 22964740 BACKGROUND

• Coleman JJ, Esposito TJ, Rozycki GS, Feliciano DV. Early subspecialization and perceived competence in surgical training: are residents ready? J Am Coll Surg. 2013 Apr;216(4):764-71; discussion 771-3. doi: 10.1016/j.jamcollsurg.2012.12.045.

  PMID: 23521960 BACKGROUND

• Mattar SG, Alseidi AA, Jones DB, Jeyarajah DR, Swanstrom LL, Aye RW, Wexner SD, Martinez JM, Ross SB, Awad MM, Franklin ME, Arregui ME, Schirmer BD, Minter RM. General surgery residency inadequately prepares trainees for fellowship: results of a survey of fellowship program directors. Ann Surg. 2013 Sep;258(3):440-9. doi: 10.1097/SLA.0b013e3182a191ca.

  PMID: 24022436 BACKGROUND

• Derossis AM, Fried GM, Abrahamowicz M, Sigman HH, Barkun JS, Meakins JL. Development of a model for training and evaluation of laparoscopic skills. Am J Surg. 1998 Jun;175(6):482-7. doi: 10.1016/s0002-9610(98)00080-4.

  PMID: 9645777 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

• Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.

  PMID: 21968548 BACKGROUND

• Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.

  PMID: 19164589 BACKGROUND

• Ciechanski P, Cheng A, Damji O, Lopushinsky S, Hecker K, Jadavji Z, Kirton A. Effects of transcranial direct-current stimulation on laparoscopic surgical skill acquisition. BJS Open. 2018 Mar 13;2(2):70-78. doi: 10.1002/bjs5.43. eCollection 2018 Apr.

  PMID: 29951631 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate (Neurosciences)

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 29, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)