Trial Outcomes & Findings for Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training (NCT NCT03083483)
NCT ID: NCT03083483
Last Updated: 2020-01-06
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
7 days
Results posted on
2020-01-06
Participant Flow
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.
2 participants were screen failures
Participant milestones
| Measure |
Bilateral M1, Active tDCS
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.
|
SMA, Active tDCS
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.
|
Sham tDCS
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 Study
STARTED
|
24
|
22
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
3
|
Reasons for withdrawal
| Measure |
Bilateral M1, Active tDCS
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.
|
SMA, Active tDCS
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.
|
Sham tDCS
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 Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
technological issues
|
1
|
0
|
1
|
Baseline Characteristics
Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training
Baseline characteristics by cohort
| Measure |
Bilateral M1, Active tDCS
n=20 Participants
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.
|
SMA, Active tDCS
n=20 Participants
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.
|
Sham tDCS
n=20 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
23.5 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
22.7 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
22.7 years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Participants who completed the study.
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)
Outcome measures
| Measure |
Bilateral M1, Active tDCS
n=20 Participants
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.
|
SMA, Active tDCS
n=20 Participants
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.
|
Sham tDCS
n=20 Participants
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.
|
|---|---|---|---|
|
Time to Completion
|
55.3 seconds to completion in post test
Standard Deviation 15.4
|
54.5 seconds to completion in post test
Standard Deviation 13.1
|
59.5 seconds to completion in post test
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 7 daysPopulation: In performing the study, only FLS task 1 was performed and evaluated. Therefore, no data was collected or analyzed on multiple tasks.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Participants who completed the study.
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.
Outcome measures
| Measure |
Bilateral M1, Active tDCS
n=20 Participants
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.
|
SMA, Active tDCS
n=20 Participants
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.
|
Sham tDCS
n=20 Participants
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.
|
|---|---|---|---|
|
Number of Errors
Drops out of view- session 1
|
1.3 errors
Standard Deviation 1.6
|
1.4 errors
Standard Deviation 1.6
|
1.2 errors
Standard Deviation 1.2
|
|
Number of Errors
Drops out of view- Session 2
|
1.5 errors
Standard Deviation 1.4
|
1.6 errors
Standard Deviation 1.7
|
1.5 errors
Standard Deviation 1.7
|
|
Number of Errors
Drops out of view- Session 3
|
1.2 errors
Standard Deviation 1.2
|
1.8 errors
Standard Deviation 1.3
|
1.3 errors
Standard Deviation 1.7
|
|
Number of Errors
Drops out of view- Session 4
|
1.7 errors
Standard Deviation 2.0
|
0.8 errors
Standard Deviation 0.9
|
1.2 errors
Standard Deviation 1.3
|
|
Number of Errors
Drops out of view- Session 5
|
1.3 errors
Standard Deviation 1.4
|
1.8 errors
Standard Deviation 1.9
|
1.7 errors
Standard Deviation 0.7
|
|
Number of Errors
Drops out of view- Session 6
|
1.0 errors
Standard Deviation 1.1
|
1.2 errors
Standard Deviation 1.4
|
1.0 errors
Standard Deviation 1.7
|
|
Number of Errors
Improper Transfers- Session 1
|
3.8 errors
Standard Deviation 12.9
|
3.1 errors
Standard Deviation 6.6
|
2.2 errors
Standard Deviation 3.3
|
|
Number of Errors
Improper Transfers- Session 2
|
4.8 errors
Standard Deviation 14
|
1.5 errors
Standard Deviation 2.4
|
1.2 errors
Standard Deviation 2.2
|
|
Number of Errors
Improper Transfers- Session 3
|
1.1 errors
Standard Deviation 2.1
|
1.0 errors
Standard Deviation 1.6
|
0.7 errors
Standard Deviation 1.4
|
|
Number of Errors
Improper Transfers- Session 4
|
0.7 errors
Standard Deviation 1.3
|
1.0 errors
Standard Deviation 1.5
|
1.4 errors
Standard Deviation 3.0
|
|
Number of Errors
Improper Transfers- Session 5
|
0.8 errors
Standard Deviation 2.6
|
0.7 errors
Standard Deviation 0.9
|
1.0 errors
Standard Deviation 2.4
|
|
Number of Errors
Improper Transfers- Session 6
|
2.0 errors
Standard Deviation 5.8
|
0.7 errors
Standard Deviation 0.9
|
1.1 errors
Standard Deviation 2.2
|
Adverse Events
Bilateral M1, Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SMA, Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bilateral M1, Active tDCS
n=21 participants at risk
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.
|
SMA, Active tDCS
n=21 participants at risk
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.
|
Sham tDCS
n=21 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Lightheadedness
|
4.8%
1/21 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
4.8%
1/21 • Number of events 1 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place