Trial Outcomes & Findings for The Efficacy of Neural Stimulation in Individuals With Schizophrenia (NCT NCT05746494)
NCT ID: NCT05746494
Last Updated: 2025-02-26
Results Overview
Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.
COMPLETED
NA
50 participants
The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation
2025-02-26
Participant Flow
A total of 50 participants were enrolled and eventually completing the whole procedure.
Participant milestones
| Measure |
Active Anodal tDCS First, Then Sham tDCS
Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.
tDCS: active anodal tDCS and sham tDCS
|
Sham tDCS First, Then Active Anodal tDCS
Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.
tDCS: active anodal tDCS and sham tDCS
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Baseline characteristics by cohort
| Measure |
Active Anodal tDCS First, Then Sham tDCS
n=26 Participants
Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.
tDCS: active anodal tDCS and sham tDCS
|
Sham tDCS First, Then Active Anodal tDCS
n=24 Participants
Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.
tDCS: active anodal tDCS and sham tDCS
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.08 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
45.46 years
STANDARD_DEVIATION 11.30 • n=7 Participants
|
44.74 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Handedness
right-handed
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Handedness
left-handed
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Years of education
|
12.42 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
13.31 years
STANDARD_DEVIATION 2.26 • n=7 Participants
|
12.85 years
STANDARD_DEVIATION 2.20 • n=5 Participants
|
|
The Wide Range Achievement Test-Reading recognition subtest 4 (WRAT-4)
|
96.11 units on a scale
STANDARD_DEVIATION 9.76 • n=5 Participants
|
94.08 units on a scale
STANDARD_DEVIATION 15.02 • n=7 Participants
|
95.14 units on a scale
STANDARD_DEVIATION 12.47 • n=5 Participants
|
|
Chlorpromazine (CPZ)-equivalent
|
468.63 mg
STANDARD_DEVIATION 1150.45 • n=5 Participants
|
396.32 mg
STANDARD_DEVIATION 520.71 • n=7 Participants
|
433.92 mg
STANDARD_DEVIATION 896.59 • n=5 Participants
|
|
Diagnoses
SCZ
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Diagnoses
SCZ-A
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Current/recent paranoia
Current
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Current/recent paranoia
Recent
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulationParanoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.
Outcome measures
| Measure |
Active Visit
n=50 Participants
Performance at the active visit
|
Sham Visit
n=50 Participants
Performance at the sham visit
|
EMA-sham
EMA-sham
|
|---|---|---|---|
|
The State Social Paranoia Scale (SSPS)
|
9.72 The change score of SSPS (pre - post)
Standard Deviation 14.61
|
3.90 The change score of SSPS (pre - post)
Standard Deviation 11.56
|
—
|
PRIMARY outcome
Timeframe: Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)Population: Only 47 (out of 50) participants completed this measure.
Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can't trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.
Outcome measures
| Measure |
Active Visit
n=47 Participants
Performance at the active visit
|
Sham Visit
n=47 Participants
Performance at the sham visit
|
EMA-sham
n=47 Participants
EMA-sham
|
|---|---|---|---|
|
Ecological Momentary Assessment (EMA)-Based Paranoia
|
3.78 units on a scale
Standard Deviation 1.72
|
3.61 units on a scale
Standard Deviation 0.91
|
3.96 units on a scale
Standard Deviation 1.85
|
PRIMARY outcome
Timeframe: The assessment was completed 30 minutes after completion of the active/sham stimulationSocial functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).
Outcome measures
| Measure |
Active Visit
n=50 Participants
Performance at the active visit
|
Sham Visit
n=50 Participants
Performance at the sham visit
|
EMA-sham
EMA-sham
|
|---|---|---|---|
|
Birchwood Social Functioning Scale (SFS)
|
114.21 units on a scale
Standard Deviation 22.35
|
114.59 units on a scale
Standard Deviation 27.54
|
—
|
PRIMARY outcome
Timeframe: Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)Population: Only 47 (out of 50) participants completed this measure.
Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).
Outcome measures
| Measure |
Active Visit
n=47 Participants
Performance at the active visit
|
Sham Visit
n=47 Participants
Performance at the sham visit
|
EMA-sham
n=47 Participants
EMA-sham
|
|---|---|---|---|
|
Ecological Momentary Assessment (EMA)-Based Social Functioning
Social interaction frequency
|
0.97 score on a scale
Standard Deviation 0.76
|
0.91 score on a scale
Standard Deviation 0.83
|
0.92 score on a scale
Standard Deviation 0.90
|
|
Ecological Momentary Assessment (EMA)-Based Social Functioning
Social interaction motivation and experience
|
3.74 score on a scale
Standard Deviation 1.62
|
4.08 score on a scale
Standard Deviation 1.68
|
3.71 score on a scale
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: The assessment was completed 30 minutes after completion of the active/sham stimulationParanoid ideation was measured by the Trustworthiness Task. This task requires participants to indicate how much they trust each of 60 grayscale facial stimuli along a 7-point Likert scale (-3 = very untrustworthy, 3 = very trustworthy). Total scores were calculated by averaging across responses and hence varied from -3 to +3, with higher values indicating a greater tendency to trust others.
Outcome measures
| Measure |
Active Visit
n=50 Participants
Performance at the active visit
|
Sham Visit
n=50 Participants
Performance at the sham visit
|
EMA-sham
EMA-sham
|
|---|---|---|---|
|
The Trustworthiness Task
|
0.07 score on a scale
Standard Deviation 1.16
|
-0.18 score on a scale
Standard Deviation 0.99
|
—
|
SECONDARY outcome
Timeframe: The assessment was completed 30 minutes after completion of the active/sham stimulationPopulation: Only 49 (out of 50) participants completed this task.
Paranoid ideation was measured by the Scrambled-sentences task (SST). This task measures the level of paranoia by asking participants to create sentences of either paranoid or nonparanoid meanings, with a greater percentage indicating a higher level of paranoid interpretation bias (range = 0-1).
Outcome measures
| Measure |
Active Visit
n=49 Participants
Performance at the active visit
|
Sham Visit
n=49 Participants
Performance at the sham visit
|
EMA-sham
EMA-sham
|
|---|---|---|---|
|
The Scrambled-sentences Task (SST)
|
0.46 score on a scale
Standard Deviation 0.29
|
0.49 score on a scale
Standard Deviation 0.28
|
—
|
SECONDARY outcome
Timeframe: The assessment was completed 30 minutes after completion of the active/sham stimulationParanoid ideation was measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Three subscores were generated: AIHQ (blame) (ranging from 3-16, with a higher score indicating a higher level of blaming tendency), AIHQ (hostility) (ranging from 1-5, with a higher score indicating a higher level of hostility), AIHQ (aggression) (ranging from 1-5, with a higher score indicating a higher level of aggression).
Outcome measures
| Measure |
Active Visit
n=50 Participants
Performance at the active visit
|
Sham Visit
n=50 Participants
Performance at the sham visit
|
EMA-sham
EMA-sham
|
|---|---|---|---|
|
The Ambiguous Intentions Hostility Questionnaire (AIHQ)
AIHQ (blame)
|
8.28 score on a scale
Standard Deviation 3.07
|
8.89 score on a scale
Standard Deviation 3.22
|
—
|
|
The Ambiguous Intentions Hostility Questionnaire (AIHQ)
AIHQ (hostility)
|
2.09 score on a scale
Standard Deviation 0.75
|
2.35 score on a scale
Standard Deviation 0.78
|
—
|
|
The Ambiguous Intentions Hostility Questionnaire (AIHQ)
AIHQ (aggression)
|
1.75 score on a scale
Standard Deviation 0.40
|
1.78 score on a scale
Standard Deviation 0.39
|
—
|
SECONDARY outcome
Timeframe: The assessment was completed 30 minutes after completion of the active/sham stimulationParanoid ideation was measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items assessing pathological hostility. A total score (range from 0-30) was generated to reflect overall hostility level, with higher total scores indicating more hostility.
Outcome measures
| Measure |
Active Visit
n=50 Participants
Performance at the active visit
|
Sham Visit
n=50 Participants
Performance at the sham visit
|
EMA-sham
EMA-sham
|
|---|---|---|---|
|
The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)
|
9.42 score on a scale
Standard Deviation 7.56
|
11.30 score on a scale
Standard Deviation 7.57
|
—
|
Adverse Events
Active Visit
Sham Visit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Linlin Fan
University of Texas at Dallas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place