Trial Outcomes & Findings for Auditory Control Enhancement (ACE) in Schizophrenia (NCT NCT06155695)
NCT ID: NCT06155695
Last Updated: 2026-04-07
Results Overview
Most trials in this task show letter A, then X, requiring response. Occasionally, stimuli other than A (generally called "B" stimuli) or other than X (generally, "Y" stimuli) are presented, requiring no response. Mean event-related spectral magnitude calculated between 200-500 ms after "A" and "B" stimuli in the beta band (15-25 Hz), across frontocentral EEG electrodes (Fz, FC1, FCz, FC2, Cz). Signals were averaged over electrodes, time, and frequency. Values reported here represent the mean of "A" and "B" responses.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Week 3 minus Week 1
Results posted on
2026-04-07
Participant Flow
Participants were recruited between 9/5/2023 and 12/1/2024 from UPMC Western Psychiatric Hospital and outpatient services.
Participant milestones
| Measure |
Auditory Control Enhancement (ACE)
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auditory Control Enhancement (ACE) in Schizophrenia
Baseline characteristics by cohort
| Measure |
Total
n=12 Participants
Total of all reporting groups
|
Auditory Control Enhancement (ACE)
n=7 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=5 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 6.6 • n=1054 Participants
|
31.2 years
STANDARD_DEVIATION 4.0 • n=527 Participants
|
28.9 years
STANDARD_DEVIATION 9.5 • n=527 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=1054 Participants
|
4 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=1054 Participants
|
3 Participants
n=527 Participants
|
4 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=1054 Participants
|
7 Participants
n=527 Participants
|
5 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1054 Participants
|
1 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=1054 Participants
|
4 Participants
n=527 Participants
|
2 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=1054 Participants
|
2 Participants
n=527 Participants
|
2 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=1054 Participants
|
7 Participants
n=527 Participants
|
5 Participants
n=527 Participants
|
|
IQ measured by the Weschler Abbreviated Scale of Intelligence
|
104 units on a scale
STANDARD_DEVIATION 16 • n=1054 Participants
|
102 units on a scale
STANDARD_DEVIATION 13 • n=527 Participants
|
108 units on a scale
STANDARD_DEVIATION 22 • n=527 Participants
|
|
Matrix Reasoning T-Score measured by the Weschler Abbreviated Scale of Intelligence
|
57 T-score
STANDARD_DEVIATION 5 • n=1054 Participants
|
57 T-score
STANDARD_DEVIATION 5 • n=527 Participants
|
58 T-score
STANDARD_DEVIATION 4 • n=527 Participants
|
|
Vocabulary T-Score measured by the Weschler Abbreviated Scale of Intelligence
|
47 T-score
STANDARD_DEVIATION 12 • n=1054 Participants
|
45 T-score
STANDARD_DEVIATION 9 • n=527 Participants
|
50 T-score
STANDARD_DEVIATION 17 • n=527 Participants
|
|
Positive Symptoms measured by the Positive and Negative Syndrome Scale
|
17 units on a scale
STANDARD_DEVIATION 5 • n=1054 Participants
|
15 units on a scale
STANDARD_DEVIATION 4 • n=527 Participants
|
22 units on a scale
STANDARD_DEVIATION 3 • n=527 Participants
|
|
Negative Symptoms measured by the Positive and Negative Syndrome Scale
|
18 units on a scale
STANDARD_DEVIATION 6 • n=1054 Participants
|
16 units on a scale
STANDARD_DEVIATION 6 • n=527 Participants
|
20 units on a scale
STANDARD_DEVIATION 7 • n=527 Participants
|
|
General Symptoms measured by the Positive and Negative Syndrome Scale
|
34 units on a scale
STANDARD_DEVIATION 6 • n=1054 Participants
|
32 units on a scale
STANDARD_DEVIATION 6 • n=527 Participants
|
36 units on a scale
STANDARD_DEVIATION 4 • n=527 Participants
|
|
Total score measured by the Positive and Negative Syndrome Scale
|
69 units on a scale
STANDARD_DEVIATION 14 • n=1054 Participants
|
64 units on a scale
STANDARD_DEVIATION 14 • n=527 Participants
|
78 units on a scale
STANDARD_DEVIATION 8 • n=527 Participants
|
PRIMARY outcome
Timeframe: Week 3 minus Week 1Most trials in this task show letter A, then X, requiring response. Occasionally, stimuli other than A (generally called "B" stimuli) or other than X (generally, "Y" stimuli) are presented, requiring no response. Mean event-related spectral magnitude calculated between 200-500 ms after "A" and "B" stimuli in the beta band (15-25 Hz), across frontocentral EEG electrodes (Fz, FC1, FCz, FC2, Cz). Signals were averaged over electrodes, time, and frequency. Values reported here represent the mean of "A" and "B" responses.
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change From Baseline in Oscillatory Measure of Cognitive Control During Stimulus Evaluation in AX Version of the Continuous Performance Test (AX-CPT)
|
-0.0394 Magnitude (Microvolts)
Standard Deviation 0.0464
|
0.0024 Magnitude (Microvolts)
Standard Deviation 0.038
|
PRIMARY outcome
Timeframe: Week 3 minus Week 1Most trials in this task show letter A, then X, requiring response. Occasionally, stimuli other than A (generally called "B" stimuli) or other than X (generally, "Y" stimuli) are presented, requiring no response. Mean event-related spectral magnitude calculated between 600-1200 ms after "A" and "B" stimuli in the gamma band (30-60 Hz), across frontocentral EEG electrodes (Fz, FC1, FCz, FC2, Cz). Signals were averaged over electrodes, time, and frequency. Values reported here represent the difference between "A" and "B" responses (B minus A)).
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change From Baseline in Oscillatory Measure of Cognitive Control During Response Preparation in A-X Version of the Continuous Performance Test (AX-CPT)
|
-0.0504 Magnitude (Microvolts)
Standard Deviation 0.0708
|
-0.0075 Magnitude (Microvolts)
Standard Deviation 0.0484
|
PRIMARY outcome
Timeframe: Week 3 minus Week 1Mean evoked event-related spectral magnitude calculated between 100-500 ms after stimulus onset and 35-45 Hz in frontocentral electrodes (Fz, FC1, FCz, FC2, Cz). Magnitude is calculated as the average over electrodes, time, and frequency. These values represent the difference between signal magnitude measures in attend and ignore conditions (attend minus ignore).
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change in Auditory Steady-State Response (ASSR) Modulation With Attention
|
0.339 Magnitude (Microvolts)
Standard Deviation 0.328
|
-0.071 Magnitude (Microvolts)
Standard Deviation 0.113
|
PRIMARY outcome
Timeframe: Week 3 minus Week 1Mean evoked event-related spectral magnitude calculated between 100-500 ms after stimulus onset and 35-45 Hz in frontocentral electrodes (Fz, FC1, FCz, FC2, Cz). Magnitude is calculated as the average over electrodes, time, and frequency. These values represent the response during ignore condition.
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change in Auditory Steady-State Response (ASSR) Amplitude.
|
-0.046 Magnitude (Microvolts)
Standard Deviation 0.054
|
0.043 Magnitude (Microvolts)
Standard Deviation 0.106
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 weeksPercentage of enrolled participants who completed the study
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=7 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=5 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Retention
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 3Subjective forced-choice impression of treatment condition assessed by a single item on study completion questionnaire - "Which treatment condition do you think you received? ACE or sham(placebo)?" Numbers reported indicate count of participants who selected "ACE".
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=7 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=5 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Blinding
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 3Acceptability rating on a visual analogue scale (0-100; greater = more acceptable) obtained via post-study survey.
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=7 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Acceptability
|
89 units on a scale
Standard Deviation 7
|
81 units on a scale
Standard Deviation 6
|
PRIMARY outcome
Timeframe: Week 1Population: Participants were unable to remain still during tDCS in the scanner. No participant had frame displacement less than the required minimum of 5 mm.
We will use General Linear Model (GLM) in SPM12 to assess the parametric modulation of 2nd-echo phase data with the applied tDCS current as a regressor. Magnetic field modulation of target areas will be quantified as the ratio of mean beta values within target areas in rVLPFC and left TPJ over the mean beta value over cortical voxels beyond these regions of interest.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 1Population: Participants were unable to remain still during tDCS in the scanner. No participant had frame displacement less than the required minimum of 5 mm.
We will use General Linear Model (GLM) in Statistical Parametric Modeling (SPM12) to assess the parametric modulation of 2nd-echo magnitude data with the applied tDCS current as a regressor. BOLD modulation within target areas will be quantified as the ratio of mean beta values within target areas in right ventrolateral prefrontal cortex (rVLPFC) and left temporoparietal junction (TPJ) over the mean beta value over cortical voxels beyond these regions of interest.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 3 minus Week 1Population: Three individuals in the sham group had unusable CBF data at either baseline or post-treatment and are not included here
Cerebral blood flow (CBF) measured by pseudo-continuous arterial spin labeling (pcASL) will be assessed in right vlPFC and left TPJ target regions
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=1 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change in Cerebral Blood Flow in Auditory Control Regions
|
3.25 mL/100g/min
Standard Deviation 8.00
|
8.41 mL/100g/min
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 3 minus Week 1t-score (mean = 50, standard deviation= 10; greater=better) obtained on the Attention scale of the National Institute of Mental Health's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)- Consensus Cognitive Battery (MCCB)
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change in MCCB Attention Scale Score
|
-2 T-score
Standard Deviation 5
|
-3 T-score
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Week 3 minus Week 1t-score (mean = 50, SD = 10; greater=better) obtained on the Processing Speed scale of the MATRICS Consensus Cognitive Battery (MCCB)
Outcome measures
| Measure |
Auditory Control Enhancement (ACE)
n=6 Participants
tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS): tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. tDCS current in the active stimulation condition was maintained at 2.0 milliamps (mA) for the first 30 minutes of each one-hour training session.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
Sham tDCS + ACCT
n=4 Participants
Sham tDCS + ACCT
Transcranial Direct Current Stimulation (tDCS):tDCS was administered using the Starstim system with anode at 10-20 location F8 and cathode at CP5. Circular, 8 sqcm sponges were used. Sham stimulation also used 2 mA current, but was ramped down to 0 mA after 30 seconds.
Auditory Cognitive Control Training (ACCT): ACCT incorporates a subset of components from Cognitive Enhancement Therapy found to have early benefits on the cognitive deficits of interest to the proposed studies and can be conducted more time-efficiently to achieve our specific goals. ACCT involves approximately 3 hours of computerized neurocognitive training using cognitive control and processing speed training software developed by Ben-Yishay and colleagues. Deficits in cognitive control are addressed with computer training exercises containing simple stimuli with little inherent emotional or motivational salience. ACCT requires individuals to be vigilant, inhibit irrelevant stimuli, and shift attention between auditory and visual modalities. Computer training exercises facilitate reaction time in a temporal mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates).
|
|---|---|---|
|
Change in MCCB Processing Speed Scale Score
|
7 T-score
Standard Deviation 9
|
-2 T-score
Standard Deviation 8
|
Adverse Events
Auditory Control Enhancement (ACE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS + ACCT
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
Dr. Brian A Coffman
University of Pittsburgh School of Medicine
Phone: 4122465123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place