An interventional study of Transcranial Direct Current Stimulation (tDCS) and Auditory Cognitive Control Training (ACCT) in Auditory Hallucinations, sponsored by Brian A Coffman, PhD. Terminated at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Brian A Coffman, PhD · Not applicable, Interventional, and Treatment
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.
136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.
This study's enrollment of 12 is below the median of 48 across 118 interventional studies indexed under Hallucinations.
Browse Hallucinations studies →This is the only study on the registry with Brian A Coffman, PhD as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tDCS + ACCT
Device: Transcranial Direct Current Stimulation (tDCS) · Behavioral: Auditory Cognitive Control Training (ACCT)
Sham tDCS + ACCT
Device: Transcranial Direct Current Stimulation (tDCS) · Behavioral: Auditory Cognitive Control Training (ACCT)
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.
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)
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.
Time frame: 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)).
Time frame: 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).
Time frame: 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.
Time frame: Week 3 minus Week 1
Retention
Percentage of enrolled participants who completed the study
Time frame: 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".
Time frame: Week 3
Acceptability
Acceptability rating on a visual analogue scale (0-100; greater = more acceptable) obtained via post-study survey.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Week 3 minus Week 1
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)
Time frame: 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)
Time frame: Week 3 minus Week 1
Participants were recruited between 9/5/2023 and 12/1/2024 from UPMC Western Psychiatric Hospital and outpatient services.
| Milestone | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Started | 7 | 5 |
| Completed | 7 | 5 |
| Not completed | 0 | 0 |
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.
| Magnitude (Microvolts) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Change From Baseline in Oscillatory Measure of Cognitive Control During Stimulus Evaluation in AX Version of the Continuous Performance Test (AX-CPT) | -0.0394 ± 0.0464 | 0.0024 ± 0.038 |
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)).
| Magnitude (Microvolts) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| 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 ± 0.0708 | -0.0075 ± 0.0484 |
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).
| Magnitude (Microvolts) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Change in Auditory Steady-State Response (ASSR) Modulation With Attention | 0.339 ± 0.328 | -0.071 ± 0.113 |
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.
| Magnitude (Microvolts) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Change in Auditory Steady-State Response (ASSR) Amplitude. | -0.046 ± 0.054 | 0.043 ± 0.106 |
Percentage of enrolled participants who completed the study
| Participants | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Retention | 7 | 5 |
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".
| Participants | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Blinding | 5 | 5 |
Acceptability rating on a visual analogue scale (0-100; greater = more acceptable) obtained via post-study survey.
| units on a scale | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Acceptability | 89 ± 7 | 81 ± 6 |
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)
| T-score | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Change in MCCB Attention Scale Score | -2 ± 5 | -3 ± 8 |
t-score (mean = 50, SD = 10; greater=better) obtained on the Processing Speed scale of the MATRICS Consensus Cognitive Battery (MCCB)
| T-score | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Change in MCCB Processing Speed Scale Score | 7 ± 9 | -2 ± 8 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Cerebral blood flow (CBF) measured by pseudo-continuous arterial spin labeling (pcASL) will be assessed in right vlPFC and left TPJ target regions
| mL/100g/min | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT |
|---|---|---|
| Change in Cerebral Blood Flow in Auditory Control Regions | 3.25 ± 8.00 | 8.41 ± 0 |
Collected over From enrollment until the end of follow-up, up to 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Auditory Control Enhancement (ACE) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Sham tDCS + ACCT | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| Mean | 31.2 ± 4.0 | 28.9 ± 9.5 | 30.2 ± 6.6 |
| Sex: Female, Male(Participants) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 3 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 5 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| United States | 7 | 5 | 12 |
| IQ measured by the Weschler Abbreviated Scale of Intelligence(units on a scale) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| Mean | 102 ± 13 | 108 ± 22 | 104 ± 16 |
| Matrix Reasoning T-Score measured by the Weschler Abbreviated Scale of Intelligence(T-score) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| Mean | 57 ± 5 | 58 ± 4 | 57 ± 5 |
| Vocabulary T-Score measured by the Weschler Abbreviated Scale of Intelligence(T-score) | Auditory Control Enhancement (ACE) | Sham tDCS + ACCT | Total |
|---|---|---|---|
| Mean | 45 ± 9 | 50 ± 17 | 47 ± 12 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All of the individual participant data (IPD) collected in the trial, following deidentification.
Supporting information: Study protocol
Time frame: Immediately following publication, and for at least 5 years
Access criteria: Researchers who have access to NIH data archive will be able to access the data
Data sharing details ↗ · reporter.nih.gov
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