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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH128823 | U.S. NIH Grant/Contract | View source |
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The study was stopped due to end of funding and low recruitment.
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this clinical trial is to investigate neural markers of target engagement to further develop auditory control enhancement (ACE) as a novel, inexpensive, and noninvasive intervention to address treatment-refractory auditory hallucinations. Here, we will address questions about the feasibility and acceptability of ACE, as well as the degree to which ACE results in measurable engagement of biophysical and neurophysiological targets.
Participants will complete:
Researchers will compare individuals receiving ACE to those receiving sham tDCS during cognitive training to determine effects of ACE.
Auditory hallucinations associated with schizophrenia (Sz) are pervasive, debilitating, and disturbing. Unfortunately, they are also difficult to treat - auditory hallucinations persist in about 25% of cases despite pharmacotherapy and treatment of cognitive symptoms (the symptoms most strongly related to global functioning) is modest at best. We propose a novel, inexpensive, and noninvasive intervention to address treatment-refractory symptoms, a critical need in Sz. Auditory hallucinations and impaired cognition in schizophrenia are not independent. Both are associated with system-level dysfunction of the fronto-temporal auditory control network, comprising auditory/verbal perceptual areas in temporoparietal junction (TPJ) and cognitive/behavioral control systems in ventrolateral prefrontal cortex (VLPFC). VLPFC traditionally inhibits and reattributes perceptual misrepresentations in most people. For those with schizophrenia, impairment of auditory cognitive control makes this impossible. Data from our lab suggest that auditory control network dysfunction may be central to the early etiology of the disorder. Auditory control enhancement (ACE) is designed to improve auditory control network function, thereby increasing inhibition of spurious auditory system activity in temporoparietal cortex and reducing auditory hallucinations. ACE combines a time-tested psychotherapeutic behavioral training program with targeted non-invasive brain stimulation using transcranial Direct Current Stimulation (tDCS). To further develop ACE for efficacy trials, we plan to investigate neural markers of target engagement in two sham-controlled experiments. Aim 1 will determine whether tDCS of right vlPFC (anode) and left TPJ (cathode) during MRI alters electric field measures and blood oxygenation level dependent (BOLD) response during stimulation to demonstrate that markers of tDCS current flow and BOLD fluctuate with induced current, and these fluctuations align spatially with computer models. Aim 2 will examine feasibility of subject retention and blinding for ACE. Aim 3 will examine the degree to which ACE modifies behavioral, neurophysiological, and hemodynamic markers of target engagement using neural oscillatory and cerebral blood flow (CBF) measures. ACE represents a novel, transformative intervention with long-lasting effects that has the potential to change the treatment of schizophrenia and vastly improve the outcome for afflicted individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory Control Enhancement (ACE) | Experimental | tDCS + ACCT |
|
| Sham tDCS + ACCT | Sham Comparator | Sham tDCS + ACCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | tDCS will be administered using the Starstim system. We will use the freely available Simulation of Non-Invasive Brain Stimulation (SimNIBS) software to optimally target the rVLPFC and left TPJ in each subject. Finite element models will be generated using T1 and T2 scans. We will generate multiple models to maximize on-target stimulation and minimize off-target stimulation, as determined by ratio of the summed current density within and beyond target regions of interest (ROIs). tDCS current in the active stimulation condition will be maintained at 2.0 milliamps (mA) for the first 45 minutes of each one-hour training session. Sham stimulation the same current, only the current will be ramped down to 0 mA after 30 seconds. Our previous research has shown this method to produce indistinguishable skin sensation. During tDCS, patients will be monitored for possible negative side effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Oscillatory Measure of Cognitive Control During Stimulus Evaluation in AX Version of the Continuous Performance Test (AX-CPT) | 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. | Week 3 minus Week 1 |
| Change From Baseline in Oscillatory Measure of Cognitive Control During Response Preparation in A-X Version of the Continuous Performance Test (AX-CPT) | 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 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)). | Week 3 minus Week 1 |
| Change in Auditory Steady-State Response (ASSR) Modulation With Attention | Mean 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). | Week 3 minus Week 1 |
| Change in Auditory Steady-State Response (ASSR) Amplitude. | Mean 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MCCB Attention Scale Score | t-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) | Week 3 minus Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian A Coffman, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
All of the individual participant data (IPD) collected in the trial, following deidentification.
Immediately following publication, and for at least 5 years
Researchers who have access to NIH data archive will be able to access the data
Not provided
Participants were recruited between 9/5/2023 and 12/1/2024 from UPMC Western Psychiatric Hospital and outpatient services.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Oscillatory Measure of Cognitive Control During Stimulus Evaluation in AX Version of the Continuous Performance Test (AX-CPT) | 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. | Posted | Mean | Standard Deviation | Magnitude (Microvolts) | Week 3 minus Week 1 |
|
From enrollment until the end of follow-up, up to 4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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The sample size here is too small to make inferences regarding effectiveness. Rather, these findings should be seen as early indications of target engagement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian A Coffman | University of Pittsburgh School of Medicine | 4122465123 | coffmanb@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2023 | Mar 17, 2026 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2023 | Nov 25, 2025 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2024 | Jan 16, 2026 | ICF_006.pdf |
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Not provided
| ID | Term |
|---|---|
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
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Not provided
Not provided
Not provided
Not provided
|
| Auditory Cognitive Control Training (ACCT) | Behavioral | 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). |
|
| Week 3 minus Week 1 |
| Retention | Percentage of enrolled participants who completed the study | Through study completion, an average of 3 weeks |
| Blinding | Subjective 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". | Week 3 |
| Acceptability | Acceptability rating on a visual analogue scale (0-100; greater = more acceptable) obtained via post-study survey. | Week 3 |
| Magnetic Field Modulation With tDCS Current | 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. | Week 1 |
| Blood-Oxygen Level Dependent (BOLD) Response Modulation With tDCS Current | 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. | Week 1 |
| Change in Cerebral Blood Flow in Auditory Control Regions | Cerebral blood flow (CBF) measured by pseudo-continuous arterial spin labeling (pcASL) will be assessed in right vlPFC and left TPJ target regions | Week 3 minus Week 1 |
| Change in MCCB Processing Speed Scale Score |
t-score (mean = 50, SD = 10; greater=better) obtained on the Processing Speed scale of the MATRICS Consensus Cognitive Battery (MCCB) |
| Week 3 minus Week 1 |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| IQ measured by the Weschler Abbreviated Scale of Intelligence | IQ is measured on a scale from 0 - 160, standardized to a population mean of 100 and standard deviation of 15. IQ is the sum of t-scores for Matrix Reasoning and Vocabulary subtests. Greater scores indicate better performance. | Mean | Standard Deviation | units on a scale |
|
| Matrix Reasoning T-Score measured by the Weschler Abbreviated Scale of Intelligence | T-scores are measured on a scale from 0 - 80, standardized to a population mean of 50 and standard deviation of 10. Greater scores indicate better performance. | Mean | Standard Deviation | T-score |
|
| Vocabulary T-Score measured by the Weschler Abbreviated Scale of Intelligence | T-scores are measured on a scale from 0 - 80, standardized to a population mean of 50 and standard deviation of 10. Greater scores indicate better performance. | Mean | Standard Deviation | T-score |
|
| Positive Symptoms measured by the Positive and Negative Syndrome Scale | This scale is the sum of seven items, each with possible scores from 1 (absent) to 7 (extreme), leading to a possible score range of 7 - 49. Greater scores indicate more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| Negative Symptoms measured by the Positive and Negative Syndrome Scale | This scale is the sum of seven items, each with possible scores from 1 (absent) to 7 (extreme), leading to a possible score range of 7 - 49. Greater scores indicate more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| General Symptoms measured by the Positive and Negative Syndrome Scale | This scale is the sum of 16 items, each with possible scores from 1 (absent) to 7 (extreme), leading to a possible score range of 16 - 112. Greater scores indicate more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| Total score measured by the Positive and Negative Syndrome Scale | This scale is the sum of the three subscales, with possible score range of 30 - 210. Greater scores indicate more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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). |
|
|
| Primary | Change From Baseline in Oscillatory Measure of Cognitive Control During Response Preparation in A-X Version of the Continuous Performance Test (AX-CPT) | 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 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)). | Posted | Mean | Standard Deviation | Magnitude (Microvolts) | Week 3 minus Week 1 |
|
|
|
| Primary | Change in Auditory Steady-State Response (ASSR) Modulation With Attention | Mean 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). | Posted | Mean | Standard Deviation | Magnitude (Microvolts) | Week 3 minus Week 1 |
|
|
|
| Primary | Change in Auditory Steady-State Response (ASSR) Amplitude. | Mean 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. | Posted | Mean | Standard Deviation | Magnitude (Microvolts) | Week 3 minus Week 1 |
|
|
|
| Primary | Retention | Percentage of enrolled participants who completed the study | Posted | Count of Participants | Participants | Through study completion, an average of 3 weeks |
|
|
|
| Primary | Blinding | Subjective 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". | Posted | Count of Participants | Participants | Week 3 |
|
|
|
| Primary | Acceptability | Acceptability rating on a visual analogue scale (0-100; greater = more acceptable) obtained via post-study survey. | Posted | Mean | Standard Deviation | units on a scale | Week 3 |
|
|
|
| Secondary | Change in MCCB Attention Scale Score | t-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) | Posted | Mean | Standard Deviation | T-score | Week 3 minus Week 1 |
|
|
|
| Secondary | Change in MCCB Processing Speed Scale Score | t-score (mean = 50, SD = 10; greater=better) obtained on the Processing Speed scale of the MATRICS Consensus Cognitive Battery (MCCB) | Posted | Mean | Standard Deviation | T-score | Week 3 minus Week 1 |
|
|
|
| Primary | Magnetic Field Modulation With tDCS Current | 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. | Participants were unable to remain still during tDCS in the scanner. No participant had frame displacement less than the required minimum of 5 mm. | Posted | Dec 2025 | Week 1 |
|
|
| Primary | Blood-Oxygen Level Dependent (BOLD) Response Modulation With tDCS Current | 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. | Participants were unable to remain still during tDCS in the scanner. No participant had frame displacement less than the required minimum of 5 mm. | Posted | Mar 2026 | Week 1 |
|
|
| Primary | Change in Cerebral Blood Flow in Auditory Control Regions | Cerebral blood flow (CBF) measured by pseudo-continuous arterial spin labeling (pcASL) will be assessed in right vlPFC and left TPJ target regions | Three individuals in the sham group had unusable CBF data at either baseline or post-treatment and are not included here | Posted | Mar 2026 | Mean | Standard Deviation | mL/100g/min | Week 3 minus Week 1 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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). | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |