- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756052
Enhancing Laparoscopic Skill Acquisition and Retention With Transcranial Direct-current Stimulation
Study Overview
Status
Conditions
Detailed Description
Rationale: Recent changes in medical training environments have resulted in many trainees lacking sufficient opportunity to acquire specific skills necessary for their specialty. New methods to enhance the acquisition and retention of medical and surgical skills are required to ensure the quality of the future physician workforce. Transcranial direct-current stimulation (tDCS) is an emerging method of non-invasive brain stimulation that has been show to safely enhance motor learning in adults and children. Even a modest enhancement of acquisition and retention of medical-surgical skill with tDCS carries the potential to accelerate skill training for health care providers, thereby contributing to greater training efficiency and improved patient outcomes.
Objectives: The objective of this study is to assess whether tDCS can enhance the acquisition and retention of laparoscopic surgical ability.
Ethics:This study has been approval by the University of Calgary Research Ethics Board
Design: Randomized, double blind, sham-controlled trial to evaluate the ability of tDCS to enhance learning and retention of laparoscopic skills.
Transcranial Direct-Current Stimulation: The tDCS methods used are based on best-available evidence and practices, and will be applied in a standardized fashion by experienced investigators. Anodal tDCS will be delivered through saline-soaked sponge electrodes using a NeuroConn Direct-Current Stimulator (NeuroConn, Ilmenau, Germany). The anode will be centered 2cm posterior to the left primary motor cortex (localized using the 10-20 EEG System), with the cathode over the contralateral supraorbital area. Both anodal and sham tDCS groups will have the current ramped up to 1milliamp over 30 seconds. In the anodal tDCS group, the current will be held for 20 minutes. In the sham tDCS condition, the current will be held for only 60 seconds (no changes in cortical excitability) followed by a 30 second ramp-down.
Participants: Medical students (years 1-3) and general surgery residents (Post-Graduate Year 1-5) from the Cumming School of Medicine (University of Calgary) will be recruited. To ensure comparable baseline skills, trainees will be excluded if they have undergone formal laparoscopic training in the past 3 months (medical students only).
Sample size calculations are based on the performance measures for the pattern cutting score, determined through pilot studies (discussed below). Based on a two-fold greater improvement in score at post-training, power of 90% and type-1 error of 0.05, the investigators estimate a sample size of a minimum of 48 participants (n=24 per stimulation condition, with an equal number of residents and medical students per arm).
Study Design: A short questionnaire will be completed to determine demographic characteristics, including: gender, age, level of training, date of last completed Fundamentals of Laparoscopic Surgery course (if applicable), how many times participants have performed laparoscopic surgery on a patient, how many times participants have performed laparoscopic tasks on a laparoscopic simulator, how often participants play video games, and how often participants play a musical instrument.
Participants will be recruited at the Advanced Technical Skills and Simulation Laboratory (University of Calgary) and be oriented to the workspace. Participants will complete laparoscopic task training on a laparoscopic box trainer (Fundamentals of Laparoscopic Surgery Trainer System, Limbs & Things Inc, Georgia, USA) consisting of an optic camera, laparoscopic instruments, and a monitor that displays the field of view. The optic camera view will be recorded for retroactive scoring. Participants will view a standardized laparoscopic training video, created by an expert in laparoscopic surgery, demonstrating two Fundamentals of Laparoscopic Surgery (FLS) tasks that will be performed using the simulator: a peg-transfer (A) and pattern cutting task (B). The peg-transfer task requires the use of two dissectors to transfer six rings to pegs on the opposite end of the pegboard, and back to the original location. The pattern-cutting task involves a 10x10cm piece of gauze with a 4cm-diameter circle pre-drawn in the middle that is placed at the center of the work-board. Participants are required to use a dissector and endoscopic scissors to cut the marked circle, freeing it from the surrounding unmarked gauze. 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 for each tasks as either: 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), or the percentage area deviation of cutting a perfect circle. A total score is calculated by subtracting the error score from the time score. These two FLS tasks represent skills that require bimanual (peg-transfer) or unimanual (pattern cutting) abilities. Furthermore, these two tasks were chosen as scores correlate with training level, and are predictive of intraoperative performance.
Participants will complete task A followed by task B, establishing baseline skill. Tasks will be recorded and scored retroactively, blinded to group allocation, to quantify time and error scores. Participants will be computer randomized to receive sham or active tDCS. Participants will perform the two FLS tasks in an interleaved manner (ABAB), a paradigm suggested to enhance laparoscopic skill acquisition, with eight training repetitions of each task. Following the final training block, the tDCS electrodes will be removed, and a final task evaluation will be performed for both task A and B. The Purdue Pegboard Test (PPT) will be performed at baseline and post-training to examine unilateral hand function, serving as a safety measure. Six weeks following the training the participants will return to assess retention of laparoscopic skill, with a single repetition of task A and B. Emerging evidence suggests that a significant decay in laparoscopic skill is present six weeks following training. The amount of laparoscopic practice between the training day and follow-up will be factored for residents, to ensure that standard training remains uninterrupted.
Data Analysis: Mean change in each outcome from baseline to post-training to follow-up will be compared between tDCS and sham (two-way repeated-measure ANOVA for factors "stimulation type" and "evaluation time point"). Two-way repeated-measures ANOVA for factors "stimulation type" and "training block" will explore the interaction between tDCS and training with or without feedback for each outcome. Any decay in PPT score in either sham or anodal tDCS groups will be evaluated using a paired-tDCS. Medical students and specialty residents will be evaluated independently. Level of training of residents will be factored retroactively into our analysis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 1N4
- Cumming School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical student or general surgery residents
- Informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Medical Student - Sham tDCS
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. |
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.
Other Names:
|
Sham Comparator: General Surgery Resident - Sham tDCS
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. |
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.
Other Names:
|
Experimental: Medical Student - Anodal tDCS
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. |
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.
Other Names:
|
Experimental: General Surgery Resident - Anodal tDCS
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fundamentals of Laparoscopic Surgery pattern cutting task total score
Time Frame: Baseline and Immediately Post-Training
|
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
Time Frame: Baseline and Immediately Post-Training
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention of Fundamentals of Laparoscopic Surgery pattern cutting task total score
Time Frame: 6 Weeks following Training
|
Retention of skill will be examined 6 weeks following the training session.
The score will be calculated as outlined in the primary outcome measure.
|
6 Weeks following Training
|
Retention of Fundamentals of Laparoscopic Surgery peg transfer task total score
Time Frame: 6 Weeks following Training
|
Retention of skill will be examined 6 weeks following the training session.
The score will be calculated as outlined in the primary outcome measure.
|
6 Weeks following Training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Purdue Pegboard Test score
Time Frame: Baseline and Immediately Post-Training
|
The Purdue Pegboard Test will be performed at baseline and immediately post-training, as a safety measure of general hand function.
Participants will have 30 seconds to place as many pegs as they using the left or right hand.
The test will be repeated 3 times with each hand.
The "Change in Purdue Pegboard Test score" will be calculated by taking an average of the score of 3 repetitions per hand.
|
Baseline and Immediately Post-Training
|
Visual Analog Scale for tDCS-sensations
Time Frame: Baseline and Immediately Post-Training
|
The sensations of "itching, burning, tingling, discomfort, and pain" will be ranked by the participant using a numeric visual analog scale.
Participants rank each sensation independently on a scale from 0-10, where "0" refers to "sensation not present", "5" refers to "sensation was moderately tolerable" and "10" refers to "sensation was untolerable".
|
Baseline and Immediately Post-Training
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REB15-2443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Laparoscopic Surgical Procedures
-
Mariner EndosurgeryHamilton Health Sciences Corporation; Federal Economic Development Agency for...Enrolling by invitation
-
Zagazig UniversityCompleted
-
Margherita CADDEDUSt. Joseph's Healthcare Hamilton; McMaster University; The Physicians' Services...Unknown
-
University of South FloridaTampa General HospitalCompletedLaparoscopic Surgery | Laparoscopy | Insufflation | Gynecologic Surgical ProceduresUnited States
-
Carmel Medical CenterCompletedLaparoscopic Surgical ProceduresIsrael
-
Ankara Mevki Military HospitalCompletedLaparoscopic Surgical Procedures
-
MedtronicRecruitingSurgical Procedures, Operative | Minimally Invasive Surgical ProceduresUnited States
-
Samsung Medical CenterCompletedSternotomy | Cardiac Surgical Procedures | Thoracic Surgical ProceduresKorea, Republic of
-
Hospices Civils de LyonCompleted
-
University Hospital, RouenNot yet recruitingAmbulatory Surgical ProceduresFrance
Clinical Trials on Sham Transcranial direct-current stimulation
-
Federal University of ParaíbaUnknown
-
D'Or Institute for Research and EducationCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsCompleted
-
University of Campinas, BrazilUnknownEpilepsy IntractableBrazil
-
Federal University of ParaíbaCompleted
-
Northwestern UniversityRecruitingDepressionUnited States
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingTranscranial Direct Current Stimulation
-
Flow Neuroscience ABUniversity of Texas; University of East LondonCompletedMajor Depressive DisorderUnited States, United Kingdom
-
University of MinnesotaWithdrawnActive tDCS | Sham tDCSUnited States
-
Burke Medical Research InstituteNew York State Spinal Cord Injury Research Board (SCIRB)Active, not recruiting