Stimulating the Brain to Improve Self-Awareness
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: The University of Texas at Dallas

 
 
 
 
 
 
 
Cover Page 
 
 
 
 
 
Title: Stimulating the Brain to Improve Self-Awareness 
 
NCT Number: NCT03370341 
 
Document Date: 9/19/2017 
 
 
 
 

Objectives 
 
The overall goal is to determine whether we can improve Introspective Accuracy (IA), defined as 
one’s ability to correctly evaluate their own skills and abilities, in individuals with schizophrenia 
by stimulating the rostrolateral prefrontal cortex via transcranial Direct Current Stimulation 
(tDCS). Participants will undergo two brain stimulation sessions (one active and one sham) 
approximately one week apart and, after each session, will complete cognitive and social 
cognitive assessments along with real-time assessments of their performance (i.e., IA). We 
hypothesize that individuals will more accurately assess their performance immediately 
following the active brain stimulation session as compared to immediately following the sham 
session. 
 
 
Design 
 
The study will utilize a double-blind, crossover design wherein participants will receive both 
active and sham stimulation in a counterbalanced order.  
 
 
Methods and Procedures 
This study will involve two sessions, completed approximately one week apart. The sessions 
will be identical except that the first session will include clinical interviews for the purposes of 
confirming diagnosis and one session will involve active neurostimulation while the other will 
involve sham stimulation. We will use a double-blind, cross-over procedure so that across 
participants the sham session will be equally likely to have occurred first or second and so that 
both participants and experimenters will be unaware of which session includes the active 
simulation. 
After providing written informed consent, participants will complete clinical measures to confirm 
diagnosis and to assess current symptomatology. These include: 
1. Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998). The MINI will 
be administered by trained study personnel. The MINI was designed to assess Axis I 
disorders as listed in the DSM-IV-TR. This interview will provide a more nuanced evaluation 
of the participant's clinical history. 
2. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient 
Edition (SCID-I- P) (First, Spitzer, Gibbon, & Williams, 2002). The SCID-I-P will be 
administered by trained study personnel. The SCID-I-P was designed as a structured 
interviewing tool to assess Axis I disorders as listed in the DSM-IV-TR. The SCID-I-P is 
considered to be the gold-standard instrument for DSM-IV diagnosis. 
3. Positive and Negative Syndrome Scale (PANSS) (Kay et al., 2009). The PANSS will be 
administered by study staff, who will be trained to gold standard reliability, to assess the 
severity of positive and negative symptoms in individuals with schizophrenia. The PANSS has 
good psychometric properties, which include internal consistency reliabilities of .72 for the 
Positive Scale, .81 for the Negative scale, and .77 for the General Psychopathology Scale. 
The PANSS demonstrates good construct validity and criterion- related validity. In a study of 
51 patients with chronic schizophrenia, the PANSS Positive scale was significantly correlated 

(r=.77, p<.001) to the Scale for Assessing Positive Symptoms (SAPS) and the PANSS 
negative scale was significantly correlated (r=.77, p<.001) with the Scale for Assessing 
Negative Symptoms (SANS) (Kay et al., 2009). 
 
Participants will then begin the neurostimulation portion of the session, which will last for 20 
minutes. The participant will be set up with the tDCS material that will start real or sham 
stimulation, and participants will be informed that they may read or otherwise entertain 
themselves during this portion of the study. The two electrodes of the tDCS will be placed over 
the left and right rostrolateral prefrontal cortex. For active stimulation the electrical current will 
be initially increased in a ramp-like fashion over several seconds (5 seconds) until reaching 
1.5mA, and stimulation will be maintained for 20 minutes until it ramps down (5 seconds). For 
sham stimulation, the electrical current will be increased in a ramp- like fashion over several 
seconds (5 seconds) until reaching 1.5mA to mimic the sensation present during the first 5 
seconds of real stimulation, and then stimulation will be stopped without the participant 
knowing. The total duration of the sham tDCS will be identical to the active condition in order to 
appropriately blind the procedure.  
 
Following the neurostimulation portion, the participant will be asked to sit quietly for 30 minutes. 
After that time has elapsed, the participant will complete the following behavioral measures in a 
random order: 
1. Wisconsin Card Sorting Task (WSCT) (Heaton, Chelune, Talley, Kay & Curtiss, 1993). The 
WCST is a widely used measure of executive function that requires participants to match a 
presented card to one of four stimulus cards. There are several ways in which the card could 
be successfully sorted but participants are not informed of the criterion they should use to 
match the card. Instead, feedback is given after each sort (i.e. correct or incorrect), and 
participants must use this information to adjust their responses. 10 minutes. 
2. Emotion Recognition 40, Degraded Stimuli (ER-40D; Kohler, Turner, Bilker, Brinsinger, 
Siegel, Kanes… Gur, 2003). The ER-40 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. For this version, 
facial stimuli are be digitally blurred in order to make the expressions more difficult to identify. 3 
minutes 
3. MATRICS Consensus Cognitive Battery - Brief (MCCB-B; Nuechterlein et al., 2008). 
Trained study staff will administer the MCCB-B to all participants to obtain an estimate of level 
of cognitive functioning. The MCCB is considered the gold standard cognitive assessment in 
schizophrenia research and assesses the following domains: Speed of processing, working 
memory, and verbal learning. 15 minutes. 
4. Emotion Recognition Signal Detection Task (ER-SDT; Tsoi et al., 2008). The ER-SDT is a 
task of emotion recognition that utilizes a signal detection framework. Participants will view 5 
different series, or blocks, of 60 emotional faces. For each block, a target emotion (i.e. happy, 
sad, anger, fear or neutral) will be identified, and participants will be asked to view each face 
and determine if that face is or is not displaying the target emotion. Following each decision, 
participants will rate their confidence in the accuracy of that decision on a 4-point scale from 
"probably wrong" to "probably right." 20 minutes 

 
 
IA procedure: For all behavioral tasks, participants will self-evaluate their performance in order 
to obtain estimates of IA. For the WCST, ratings of confidence in correctness are performed 
after each sort in the 64-card WCST. For the ER-40D, ratings will be performed after each of 
the 40 trials. For our cognitive assessment battery, the MCCB, performance will be rated after 
each of the 5 tests. As noted, for the ER- SDT task, participants will self-evaluate their 
correctness after each item. 
 
At the end of the session, we will ask participants to report which session they believed they 
just received. This will allow us to assess the success of our blinding procedure. 
 
 
Statistical Analysis Plan 
 
Repeated Measures ANOVAs will be used to compare indices of neurocognitive and social 
cognitive IA between stimulation conditions.