Trial Outcomes & Findings for Stimulating the Social Brain (NCT NCT03374631)
NCT ID: NCT03374631
Last Updated: 2023-03-22
Results Overview
Level of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein \& Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.
COMPLETED
NA
40 participants
Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
2023-03-22
Participant Flow
Participant milestones
| Measure |
Active Anodal tDCS, Then Sham tDCS
Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing
active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
|
Sham tDCS, Then Active Anodal tDCS
Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing.
active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
|
|---|---|---|
|
First Intervention (20 Minutes)
STARTED
|
20
|
20
|
|
First Intervention (20 Minutes)
COMPLETED
|
20
|
20
|
|
First Intervention (20 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
20
|
20
|
|
Washout (1 Week)
COMPLETED
|
20
|
20
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (20 Minutes)
STARTED
|
20
|
20
|
|
Second Intervention (20 Minutes)
COMPLETED
|
20
|
20
|
|
Second Intervention (20 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stimulating the Social Brain
Baseline characteristics by cohort
| Measure |
Active Anodal tDCS, Then Sham tDCS
n=20 Participants
Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing
active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
|
Sham tDCS, Then Active Anodal tDCS
n=20 Participants
Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing.
active anodal tDCS: active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
sham tDCS: sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 2.30 • n=5 Participants
|
19.6 years
STANDARD_DEVIATION 1.98 • n=7 Participants
|
20.15 years
STANDARD_DEVIATION 2.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 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
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulationLevel of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein \& Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.
Outcome measures
| Measure |
Active Stimulation
n=40 Participants
20 minutes of Active anodal tDCS followed by behavioral testing
|
Sham Stimulation
n=40 Participants
20 minutes of Sham tDCS followed by behavioral testing
|
|---|---|---|
|
Change in General Paranoid Ideation for Active vs. Sham Simulation
|
1.60 score on a scale
Standard Deviation 3.11
|
.73 score on a scale
Standard Deviation 3.80
|
PRIMARY outcome
Timeframe: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulationLevel of paranoid ideation will be assessed with the persecution subscale of the State Social Paranoia Scale (SSPS: Freeman et al., 2007) both before and after tDCS to assess changes related to tDCS. The SSPS is a psychometrically sound 20-item self- report measure assessing current levels of paranoid, positive, and neutral thinking about others. Ten items comprise the persecution subscale, and scores on this subscale range from 10-50 with higher scores indicating greater paranoia. The amount of pre-post change (i.e.SSPS score before stimulation minus SSPS score after stimulation) will be compared between active and sham stimulation. Positive values indicate reductions in paranoia after stimulation.
Outcome measures
| Measure |
Active Stimulation
n=40 Participants
20 minutes of Active anodal tDCS followed by behavioral testing
|
Sham Stimulation
n=40 Participants
20 minutes of Sham tDCS followed by behavioral testing
|
|---|---|---|
|
Change in Change in Social Paranoia for Active vs. Sham Simulation
|
.75 score on a scale
Standard Deviation 2.52
|
.93 score on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: assessed 30 minutes after completion of the active/sham stimulationParticipants will complete the Trustworthiness Task (Adolphs, Tranel, \& Damasio, 1998), which asks individuals to view 42 images of others and rate their level of trustworthiness on a scale from -3 to 3. Scores range from -126 to 126. Higher scores indicate greater perceptions of trustworthiness. Mean ratings following each stimulation type (active vs. sham) are calculated.
Outcome measures
| Measure |
Active Stimulation
n=40 Participants
20 minutes of Active anodal tDCS followed by behavioral testing
|
Sham Stimulation
n=40 Participants
20 minutes of Sham tDCS followed by behavioral testing
|
|---|---|---|
|
Trustworthiness Task Score for Active vs. Sham Stimulation
|
-.14 score on a scale
Standard Deviation .64
|
-.14 score on a scale
Standard Deviation .60
|
SECONDARY outcome
Timeframe: assessed 30 minutes after completion of the active/sham stimulationThe Emotion Recognition 40 (ER-40; Kohler, Turner, Bilker, Brinsinger, Siegel, Kanes... Gur, 2003) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face. Scores range from 0-40 with higher scores indicating better accuracy. Mean performance following each stimulation type (active vs. sham) are calculated.
Outcome measures
| Measure |
Active Stimulation
n=40 Participants
20 minutes of Active anodal tDCS followed by behavioral testing
|
Sham Stimulation
n=40 Participants
20 minutes of Sham tDCS followed by behavioral testing
|
|---|---|---|
|
Penn Emotion Recognition Test for Active vs. Sham Stimulation
|
35.05 score on a scale
Standard Deviation 2.39
|
35.33 score on a scale
Standard Deviation 2.31
|
Adverse Events
Active Anodal tDCS
Sham tDCS
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