Trial Outcomes & Findings for The Role of Different Prefrontal Areas in Visual Metacognition (NCT NCT04263766)
NCT ID: NCT04263766
Last Updated: 2023-09-15
Results Overview
The average confidence difference for each delay condition and the 0 ms condition for each group (DLPFC or vertex). Confidence was self-reported together with the decision on a 4-point scale with the minimum score being one (not confident at all) and the highest score being four (very confident). The range of the scale is 1 (not confident at all) to 4 (very confident).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
6 months
Results posted on
2023-09-15
Participant Flow
Participant milestones
| Measure |
DLPFC Group
The experiment has a within-subject design where each subject will receive TMS to DLPFC at different time point (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after the stimulus presentation.
|
Vertex Group
The experiment has a within-subject design where each subject will receive TMS to vertex at different time point (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after the stimulus presentation.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
26
|
|
Overall Study
COMPLETED
|
43
|
19
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
DLPFC Group
The experiment has a within-subject design where each subject will receive TMS to DLPFC at different time point (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after the stimulus presentation.
|
Vertex Group
The experiment has a within-subject design where each subject will receive TMS to vertex at different time point (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after the stimulus presentation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
Baseline Characteristics
Some of the participants didn't provide the date of birth.
Baseline characteristics by cohort
| Measure |
DLPFC Group
n=50 Participants
The experiment has a within-subject design where each subject will receive TMS (Transcranial magnetic stimulation) at DLPFC at different time point (0 ms, 200 ms, 300 ms, 400 ms, 500 ms) after the stimulus presentation in order to reveal the timing of confidence computation in DLPFC.
|
Vertex Group
n=26 Participants
The experiment has a within-subject design where each subject will receive TMS (Transcranial magnetic stimulation) at vertex at different time point (0 ms, 200 ms, 300 ms, 400 ms, 500 ms) after the stimulus presentation in order to reveal the timing of confidence computation in DLPFC.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.75 years
STANDARD_DEVIATION 1.81 • n=34 Participants • Some of the participants didn't provide the date of birth.
|
20.96 years
STANDARD_DEVIATION 10.18 • n=19 Participants • Some of the participants didn't provide the date of birth.
|
20.86 years
STANDARD_DEVIATION 2.61 • n=53 Participants • Some of the participants didn't provide the date of birth.
|
|
Sex: Female, Male
Female
|
23 Participants
n=50 Participants
|
12 Participants
n=26 Participants
|
35 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=50 Participants
|
14 Participants
n=26 Participants
|
41 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=50 Participants
|
16 Participants
n=26 Participants
|
48 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=50 Participants
|
1 Participants
n=26 Participants
|
4 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=50 Participants
|
9 Participants
n=26 Participants
|
23 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=50 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
26 participants
n=26 Participants
|
76 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population is after the exclusion of subjects who have their 0 ms condition accuracy 3.5% lower than the average accuracy of all delay conditions
The average confidence difference for each delay condition and the 0 ms condition for each group (DLPFC or vertex). Confidence was self-reported together with the decision on a 4-point scale with the minimum score being one (not confident at all) and the highest score being four (very confident). The range of the scale is 1 (not confident at all) to 4 (very confident).
Outcome measures
| Measure |
DLPFC-300 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 300 ms condition and the 0 ms condition for DLPFC group.
|
DLPFC-400 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 400 ms condition and the 0 ms condition for DLPFC group.
|
DLPFC-500 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 500 ms condition and the 0 ms condition for DLPFC group.
|
DLPFC-200 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 200 ms condition and the 0 ms condition for DLPFC group.
|
Vertex-200 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 200 ms condition and the 0 ms condition for vertex group.
|
Vertex-300 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 300 ms condition and the 0 ms condition for vertex group.
|
Vertex-400 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 400 ms condition and the 0 ms condition for vertex group.
|
Vertex-500 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 500 ms condition and the 0 ms condition for vertex group.
|
|---|---|---|---|---|---|---|---|---|
|
Average Confidence Difference With the 0 ms Condition
|
0.14 score on a scale (1-4)
Standard Deviation 0.15
|
0.14 score on a scale (1-4)
Standard Deviation 0.14
|
0.15 score on a scale (1-4)
Standard Deviation 0.17
|
0.14 score on a scale (1-4)
Standard Deviation 0.15
|
-0.01 score on a scale (1-4)
Standard Deviation 0.05
|
-0.04 score on a scale (1-4)
Standard Deviation 0.08
|
-0.04 score on a scale (1-4)
Standard Deviation 0.10
|
-0.04 score on a scale (1-4)
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: 6 monthPopulation: The analysis population is after the exclusion of subjects whose 0 ms condition accuracy is 3.5% lower than the average accuracy of all four delay conditions.
The average Mratio difference for each delay condition and the 0 ms condition for each group (DLPFC or vertex). The Mratio is derived from signal detection theoretical modeling of the observer's decision and confidence response. It is the ratio of two measures: the observer's metacognitive sensitivity (meta-d', the ability to discriminate between correct and incorrect responses) and the observer's stimulus sensitivity (d', the ability to discriminate between the two stimulus classes). The Mratio could be calculated from subjects' self-rated confidence together with task performance.
Outcome measures
| Measure |
DLPFC-300 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 300 ms condition and the 0 ms condition for DLPFC group.
|
DLPFC-400 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 400 ms condition and the 0 ms condition for DLPFC group.
|
DLPFC-500 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 500 ms condition and the 0 ms condition for DLPFC group.
|
DLPFC-200 ms
n=31 Participants
The study features a within-subject design in which subjects receive TMS at DLPFC at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at DLPFC, for 200 ms condition. The measurement is the confidence difference between the 200 ms condition and the 0 ms condition for DLPFC group.
|
Vertex-200 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 200 ms condition and the 0 ms condition for vertex group.
|
Vertex-300 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 300 ms condition and the 0 ms condition for vertex group.
|
Vertex-400 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 400 ms condition and the 0 ms condition for vertex group.
|
Vertex-500 ms
n=16 Participants
The study features a within-subject design in which subjects receive TMS at vertex at 5 different time points (0 ms, 200 ms, 300 ms, 400 ms, and 500 ms) after stimulus presentation. This arm is for the data of subjects who receive TMS at vertex, for 200 ms condition. The measurement is the confidence difference between the 500 ms condition and the 0 ms condition for vertex group.
|
|---|---|---|---|---|---|---|---|---|
|
Average Mratio Difference With the 0 ms Condition
|
0.087 Ratio
Standard Deviation 0.429
|
0.043 Ratio
Standard Deviation 0.586
|
0.070 Ratio
Standard Deviation 0.467
|
0.014 Ratio
Standard Deviation 0.959
|
-0.211 Ratio
Standard Deviation 0.453
|
-0.170 Ratio
Standard Deviation 0.436
|
0.043 Ratio
Standard Deviation 0.386
|
0.077 Ratio
Standard Deviation 0.432
|
Adverse Events
DLPFC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vertex Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place