Trial Outcomes & Findings for Stimulating the Brain to Improve Self-Awareness (NCT NCT03370341)
NCT ID: NCT03370341
Last Updated: 2023-03-22
Results Overview
Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Assessment will be completed 30 minutes after completion of the active/sham stimulation
Results posted on
2023-03-22
Participant Flow
Participant milestones
| Measure |
Active Anodal tDCS First, Then Sham Stimulation
Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham stimulation followed by behavioral testing
Intervention: Device: active anodal tDCS
|
Sham tDCS First, Then Active Stimulation
Sham tDCS followed by behavioral testing; Washout (1 week); Active Stimulation followed by behavioral testing
Intervention: Device: sham tDCS
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active Anodal tDCS First, Then Sham Stimulation
Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham stimulation followed by behavioral testing
Intervention: Device: active anodal tDCS
|
Sham tDCS First, Then Active Stimulation
Sham tDCS followed by behavioral testing; Washout (1 week); Active Stimulation followed by behavioral testing
Intervention: Device: sham tDCS
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Stimulating the Brain to Improve Self-Awareness
Baseline characteristics by cohort
| Measure |
Active Anodal tDCS First, Then Sham Stimulation
n=21 Participants
Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham tDCS followed by behavioral testing
Intervention: Device: active anodal tDCS
|
Sham tDCS First, Then Active Stimulation
n=20 Participants
Sham tDCS followed by behavioral testing; Washout (1 week); Active tDCS followed by behavioral testing Intervention: Device: sham tDCS
sham tDCS: sham tDCS with behavioral tasks to assess IA
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.43 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
39.58 years
STANDARD_DEVIATION 9.84 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Education
|
12.33 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
12.34 years
STANDARD_DEVIATION 1.93 • n=7 Participants
|
12.34 years
STANDARD_DEVIATION 2.41 • n=5 Participants
|
|
Estimated IQ
|
98.95 units on a scale
STANDARD_DEVIATION 11.57 • n=5 Participants
|
94.26 units on a scale
STANDARD_DEVIATION 10.01 • n=7 Participants
|
96.73 units on a scale
STANDARD_DEVIATION 10.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessment will be completed 30 minutes after completion of the active/sham stimulationNeurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Outcome measures
| Measure |
Active Anodal tDCS
n=40 Participants
20 minutes of Active anodal tDCS followed by behavioral testing
|
Sham tDCS
n=40 Participants
20 minutes of Sham tDCS followed by behavioral testing
|
|---|---|---|
|
Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation
|
.534 score on a scale
Standard Deviation .068
|
.526 score on a scale
Standard Deviation .085
|
SECONDARY outcome
Timeframe: Assessment will be completed 30 minutes after completion of the active/sham stimulationSocial Cognitive Introspective Accuracy assessed with the Penn Emotion Recognition Task (ER40) after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Outcome measures
| Measure |
Active Anodal tDCS
n=40 Participants
20 minutes of Active anodal tDCS followed by behavioral testing
|
Sham tDCS
n=40 Participants
20 minutes of Sham tDCS followed by behavioral testing
|
|---|---|---|
|
Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation
|
.575 score on a scale
Standard Deviation .095
|
.562 score on a scale
Standard Deviation .098
|
Adverse Events
Active Anodal tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
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