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Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

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ClinicalTrials.gov Identifier: NCT03083483
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : November 14, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Healthy Volunteers
Intervention Device: transcranial direct current stimulation (tDCS)
Enrollment 71
Recruitment Details The recruitment period ran from 5/1/17 to 12/20/17. Subjects were recruited off of the Duke University Behavioral Research Lab Sessions Scheduling Website for undergraduate and graduate students, Duke School of Medicine students in the Trent Semans Center and Duke South Clinics, and Duke Pre-Medical undergraduate students.
Pre-assignment Details 2 participants were screen failures
Arm/Group Title Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 24 22 23
Completed 20 20 20
Not Completed 4 2 3
Reason Not Completed
Adverse Event             1             1             1
Lost to Follow-up             2             1             1
technological issues             1             0             1
Arm/Group Title Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
Participants who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 60 participants
21.9  (5.2) 23.5  (5.4) 22.7  (3.7) 22.7  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
12
  60.0%
16
  80.0%
14
  70.0%
42
  70.0%
Male
8
  40.0%
4
  20.0%
6
  30.0%
18
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Hispanic or Latino
2
  10.0%
3
  15.0%
2
  10.0%
7
  11.7%
Not Hispanic or Latino
18
  90.0%
17
  85.0%
18
  90.0%
53
  88.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
9
  45.0%
6
  30.0%
5
  25.0%
20
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   5.0%
1
   1.7%
Black or African American
3
  15.0%
2
  10.0%
4
  20.0%
9
  15.0%
White
6
  30.0%
10
  50.0%
8
  40.0%
24
  40.0%
More than one race
1
   5.0%
2
  10.0%
1
   5.0%
4
   6.7%
Unknown or Not Reported
1
   5.0%
0
   0.0%
1
   5.0%
2
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 60 participants
20 20 20 60
1.Primary Outcome
Title Time to Completion
Hide Description 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)
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: seconds to completion in post test
55.3  (15.4) 54.5  (13.1) 59.5  (18.3)
2.Secondary Outcome
Title Number of Tasks Completed
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
In performing the study, only FLS task 1 was performed and evaluated. Therefore, no data was collected or analyzed on multiple tasks.
Arm/Group Title Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Errors
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study.
Arm/Group Title Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: errors
Drops out of view- session 1 1.3  (1.6) 1.4  (1.6) 1.2  (1.2)
Drops out of view- Session 2 1.5  (1.4) 1.6  (1.7) 1.5  (1.7)
Drops out of view- Session 3 1.2  (1.2) 1.8  (1.3) 1.3  (1.7)
Drops out of view- Session 4 1.7  (2.0) 0.8  (0.9) 1.2  (1.3)
Drops out of view- Session 5 1.3  (1.4) 1.8  (1.9) 1.7  (0.7)
Drops out of view- Session 6 1.0  (1.1) 1.2  (1.4) 1.0  (1.7)
Improper Transfers- Session 1 3.8  (12.9) 3.1  (6.6) 2.2  (3.3)
Improper Transfers- Session 2 4.8  (14) 1.5  (2.4) 1.2  (2.2)
Improper Transfers- Session 3 1.1  (2.1) 1.0  (1.6) 0.7  (1.4)
Improper Transfers- Session 4 0.7  (1.3) 1.0  (1.5) 1.4  (3.0)
Improper Transfers- Session 5 0.8  (2.6) 0.7  (0.9) 1.0  (2.4)
Improper Transfers- Session 6 2.0  (5.8) 0.7  (0.9) 1.1  (2.2)
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/21 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/21 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bilateral M1, Active tDCS SMA, Active tDCS Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      1/21 (4.76%)      1/21 (4.76%)    
Injury, poisoning and procedural complications       
Lightheadedness * [1]  1/21 (4.76%)  1 1/21 (4.76%)  1 1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
[1]
tDCS stimulation
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Hannah Palmer
Organization: Duke University
Phone: 919-613-7665
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03083483     History of Changes
Other Study ID Numbers: Pro00078782
First Submitted: March 14, 2017
First Posted: March 20, 2017
Results First Submitted: October 17, 2018
Results First Posted: November 14, 2018
Last Update Posted: January 17, 2019