Trial Outcomes & Findings for Improving Visual Attention in Schizophrenia (NCT NCT03880227)
NCT ID: NCT03880227
Last Updated: 2021-07-13
Results Overview
Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing static, emotional faces (stimuli: Emotion Recognition - 40). AOIs for static faces will be defined as core facial features (i.e. eyes, nose, mouth).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Assessment will be completed 30 minutes after completion of the active/sham stimulation
Results posted on
2021-07-13
Participant Flow
81 participants were recruited to the study between March 2019 and March 2020 at a university site in Dallas, TX.
At enrollment, all participants were matched in pairs based upon key demographic factors (i.e., age, race, gender, and education), and pairs were randomly assigned to stimulation condition, resulting in separate rTPJ and dmPFC stimulation groups. 5 participants did not complete both study visits, with 4 participants not returning to their second visit, and 1 participant discontinuing their first visit prior to stimulation procedures.
Participant milestones
| Measure |
Anodal Followed by Sham Stimulation tDCS to rTPJ
Active stimulation tDCS over the rTPJ followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
After 1 week washout, sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
|
Anodal Followed by Sham Stimulation tDCS to dmPFC
Active stimulation tDCS over the dmPFC followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
After 1 week washout, sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
|
Sham Followed by Anodal Stimulation tDCS to rTPJ
Sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
After 1 week delay, Active stimulation tDCS over the rTPJ followed by behavioral testing.
Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
|
Sham Followed by Anodal Stimulation tDCS to dmPFC
Sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
After 1 week delay, Active stimulation tDCS over the dmPFC followed by behavioral testing.
Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
|
|---|---|---|---|---|
|
First Visit
STARTED
|
20
|
21
|
22
|
18
|
|
First Visit
COMPLETED
|
19
|
21
|
22
|
18
|
|
First Visit
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
1 Week Washout/ Delay
STARTED
|
19
|
21
|
22
|
18
|
|
1 Week Washout/ Delay
COMPLETED
|
19
|
20
|
19
|
18
|
|
1 Week Washout/ Delay
NOT COMPLETED
|
0
|
1
|
3
|
0
|
|
Second Visit
STARTED
|
19
|
20
|
19
|
18
|
|
Second Visit
COMPLETED
|
19
|
20
|
19
|
18
|
|
Second Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Anodal Followed by Sham Stimulation tDCS to rTPJ
Active stimulation tDCS over the rTPJ followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
After 1 week washout, sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
|
Anodal Followed by Sham Stimulation tDCS to dmPFC
Active stimulation tDCS over the dmPFC followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
After 1 week washout, sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
|
Sham Followed by Anodal Stimulation tDCS to rTPJ
Sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
After 1 week delay, Active stimulation tDCS over the rTPJ followed by behavioral testing.
Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
|
Sham Followed by Anodal Stimulation tDCS to dmPFC
Sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes
After 1 week delay, Active stimulation tDCS over the dmPFC followed by behavioral testing.
Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down)
|
|---|---|---|---|---|
|
First Visit
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
1 Week Washout/ Delay
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
1 Week Washout/ Delay
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
|
1 Week Washout/ Delay
Incompatibility with technical component (eyetracking)
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Improving Visual Attention in Schizophrenia
Baseline characteristics by cohort
| Measure |
Anodal/Sham Stimulation tDCS to rTPJ
n=42 Participants
Within subject design - sham and anodal tDCS to the rTPJ followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Anodal/Sham Stimulation tDCS to dmPFC
n=39 Participants
Within subject design - sham and anodal tDCS to the dmPFC followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.74 years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
40.79 years
STANDARD_DEVIATION 11.55 • n=7 Participants
|
40.77 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
42 participants
n=5 Participants
|
39 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessment will be completed 30 minutes after completion of the active/sham stimulationPopulation: Population analyzed were those that completed both active and sham stimulations (n=5 removed) with valid eyetracking data (n=2 removed)
Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing static, emotional faces (stimuli: Emotion Recognition - 40). AOIs for static faces will be defined as core facial features (i.e. eyes, nose, mouth).
Outcome measures
| Measure |
Anodal Stimulation tDCS to rTPJ
n=37 Participants
anodal tDCS to the rTPJ followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to rTPJ
n=37 Participants
sham tDCS to the rTPJ followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Anodal Stimulation tDCS to dmPFC
n=37 Participants
anodal tDCS to the dmPFC followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to dmPFC
n=37 Participants
sham tDCS to the dmPFC followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
|---|---|---|---|---|
|
Visual Attention to Static Faces
|
0.54 proportion of time attending to AOIs
Standard Deviation 0.15
|
0.52 proportion of time attending to AOIs
Standard Deviation 0.15
|
0.57 proportion of time attending to AOIs
Standard Deviation 0.13
|
0.53 proportion of time attending to AOIs
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Assessment will be completed 30 minutes after completion of the active/sham stimulationPopulation: Population analyzed were those that completed both active and sham stimulations (n=5 removed) with valid eyetracking data (n=2 removed)
Visual attention measured via eye-tracking(percentage of time attending to investigator designated AOIs) when viewing videos of a single actor (stimuli: Bell Lysaker Emotion Recognition Task). AOIs for this task will be defined as core facial features (i.e. eyes, nose, and mouth).
Outcome measures
| Measure |
Anodal Stimulation tDCS to rTPJ
n=37 Participants
anodal tDCS to the rTPJ followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to rTPJ
n=37 Participants
sham tDCS to the rTPJ followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Anodal Stimulation tDCS to dmPFC
n=37 Participants
anodal tDCS to the dmPFC followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to dmPFC
n=37 Participants
sham tDCS to the dmPFC followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
|---|---|---|---|---|
|
Visual Attention to Dynamic Actor
|
0.47 proportion of time attending to AOIs
Standard Deviation 0.12
|
0.46 proportion of time attending to AOIs
Standard Deviation 0.11
|
0.47 proportion of time attending to AOIs
Standard Deviation 0.11
|
0.47 proportion of time attending to AOIs
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Assessment will be completed 30 minutes after completion of the active/sham stimulationPopulation: Population analyzed were those that completed both active and sham stimulations (n=5 removed) with valid eyetracking data (n=2 removed)
Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing videos of two or more actors in a scene (stimuli: The Awareness of Social Inference Task Part 3, Version A). AOIs for this task will be defined as salient social and contextual stimuli (e.g. social stimuli are faces of actors, while contextually salient stimuli include items actors are talking about, such as a plate full of food or an empty wallet).
Outcome measures
| Measure |
Anodal Stimulation tDCS to rTPJ
n=37 Participants
anodal tDCS to the rTPJ followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to rTPJ
n=37 Participants
sham tDCS to the rTPJ followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Anodal Stimulation tDCS to dmPFC
n=37 Participants
anodal tDCS to the dmPFC followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to dmPFC
n=37 Participants
sham tDCS to the dmPFC followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
|---|---|---|---|---|
|
Visual Attention to Dynamic Social Scenes
|
0.22 proportion of time attending to AOIs
Standard Deviation 0.06
|
0.23 proportion of time attending to AOIs
Standard Deviation 0.07
|
0.26 proportion of time attending to AOIs
Standard Deviation 0.07
|
0.25 proportion of time attending to AOIs
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Assessment will be completed 30 minutes after completion of the active/sham stimulationPopulation: Population analyzed were those that completed both active and sham stimulations (n=6 removed) with valid eyetracking data (n=2 removed)
Stabilization of visual fixation on fixation circle positioned in middle of screen. Participants will be placed in front of an eyetracking device and asked to keep their eyes focused on a circle in the middle of the screen. Stabilization will be measured via eye-tracking as the deviation from a single point on screen, calculated by assessing the sum of squares of both the x and y axis (output from eyetracking device). Higher number indicates more movement, and thus less stabilization.
Outcome measures
| Measure |
Anodal Stimulation tDCS to rTPJ
n=37 Participants
anodal tDCS to the rTPJ followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to rTPJ
n=37 Participants
sham tDCS to the rTPJ followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Anodal Stimulation tDCS to dmPFC
n=36 Participants
anodal tDCS to the dmPFC followed by behavioral testing
Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to dmPFC
n=36 Participants
sham tDCS to the dmPFC followed by behavioral testing
Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
|---|---|---|---|---|
|
Fixation Stabilization
|
0.10 pixels (equivalent: 1/96th in or 0.26mm)
Standard Deviation 0.24
|
0.08 pixels (equivalent: 1/96th in or 0.26mm)
Standard Deviation 0.14
|
0.05 pixels (equivalent: 1/96th in or 0.26mm)
Standard Deviation 0.10
|
0.07 pixels (equivalent: 1/96th in or 0.26mm)
Standard Deviation 0.14
|
Adverse Events
Anodal Stimulation tDCS to rTPJ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS to rTPJ
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Anodal Stimulation tDCS to dmPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS to dmPFC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anodal Stimulation tDCS to rTPJ
n=38 participants at risk
anodal tDCS to the rTPJ followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to rTPJ
n=41 participants at risk
sham tDCS to the rTPJ followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
Anodal Stimulation tDCS to dmPFC
n=39 participants at risk
anodal tDCS to the dmPFC followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention
|
Sham tDCS to dmPFC
n=38 participants at risk
sham tDCS to the dmPFC followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention
|
|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
0.00%
0/38 • From time of visit 1 through the follow up phone call (Average time around 10 days, longest duration 29 days)
Routine effects of tDCS were assessed during visit and in follow up phone calls performed after scheduled visits. Definition of adverse events are any events that were beyond these typically reported events.
|
2.4%
1/41 • Number of events 1 • From time of visit 1 through the follow up phone call (Average time around 10 days, longest duration 29 days)
Routine effects of tDCS were assessed during visit and in follow up phone calls performed after scheduled visits. Definition of adverse events are any events that were beyond these typically reported events.
|
0.00%
0/39 • From time of visit 1 through the follow up phone call (Average time around 10 days, longest duration 29 days)
Routine effects of tDCS were assessed during visit and in follow up phone calls performed after scheduled visits. Definition of adverse events are any events that were beyond these typically reported events.
|
0.00%
0/38 • From time of visit 1 through the follow up phone call (Average time around 10 days, longest duration 29 days)
Routine effects of tDCS were assessed during visit and in follow up phone calls performed after scheduled visits. Definition of adverse events are any events that were beyond these typically reported events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place