Hallucinations, AuditoryNCT05165654
Improving Hallucinations by Targeting the rSTS With tES
A study testing Transcranial Electrical Stimulation in people with Hallucinations, Auditory and Psychosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Hallucinations are a core diagnostic feature of psychotic disorders. They involve different sensory modalities, including auditory, visual, olfactory, tactile, and gustatory hallucinations, among others. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hallucinations, Auditory, Psychosis
- What is being tested?
- Transcranial Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years of age
- Proficient in English
- Able to give informed consent
- Actively experiencing hallucinations (tactile, auditory, visual, etc.)
- Has not recently participated in tES/TMS treatments
Who cannot join
- Substance abuse or dependence (w/in past 6 months)
- Those who are pregnant/breastfeeding
- History of head injury with > 15 minutes of loss of consciousness/mal sequelae
- DSM-V intellectual disability
- Having a non-removable ferromagnetic metal within the body (particularly in the head)
- History of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Improving Hallucinations by Targeting the Right Superior Temporal Sulcus With Electrical Stimulation
Hallucinations are a core diagnostic feature of psychotic disorders. They involve different sensory modalities, including auditory, visual, olfactory, tactile, and gustatory hallucinations, among others. Hallucinations occur in multiple different neurological and psychiatric illnesses and can be refractory to existing treatments. Auditory hallucinations and visual hallucinations are found across diagnostic categories of psychotic disorders (schizophrenia, schizoaffective, bipolar disorder). Despite visual hallucinations being approximately half as frequent as auditory hallucinations, they almost always co-occur with auditory hallucinations, and are linked to a more severe psychopathological profile. Auditory and visual hallucinations at baseline also predict higher disability, risk of relapse and duration of psychosis after 1 and 2 years, especially when they occur in combination. Using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions connected to the right superior temporal sulcus (rSTS) plays a causal role in the development of hallucinations. The rSTS receives convergent somatosensory, auditory, and visual inputs, and is regarded as a site for multimodal sensory integration. Here the investigators aim to answer the question whether noninvasive brain stimulation when optimally targeted to the rSTS can improve brain activity, sensory integration, and hallucinations.
Read the detailed description
Functional neuroimaging studies have identified neural correlates of hallucinations across multiple brain regions. Some studies suggest a common neuroanatomical substrate independent of the sensory modality, while others suggest different neural correlates for different types of hallucinations. However, whether these neuroimaging findings represented a cause, consequence or epiphenomenon of hallucinations was unclear until recently. Using lesion network mapping, researchers demonstrated that focal brain lesions play a causal role in the development of hallucinations and can occur in different brain locations, both inside and outside sensory pathway, and that greater than 90% of lesion locations causing hallucinations are negatively connected to the right superior temporal sulcus (rSTS). The rSTS is known to play a role in social cognition, biological motion, audiovisual integration, and speech. Hence, when spontaneous activity decreases at lesion locations causing hallucinations, spontaneous activity in the rSTS increases, the exact pattern thought to predispose to hallucinations. Additionally, functional connectivity within this region is abnormal in patients with visual and auditory hallucinations. Therefore, the association between rSTS connectivity and hallucinations would suggest this region may be optimal for modulation via non-invasive brain stimulation.
One method by which cortical excitability can be altered is with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. High definition tDCS (HD-tDCS) is a refined version of tDCS with improved spatial precision of cortical stimulation. This involves the application of a weak electrical current (1-2 mA) delivered to the brain via scalp electrodes. tDCS can modulate cortical excitability, where anodal stimulation tends to increase (i.e. the resting potential becomes less negative) and cathodal stimulation tends to decrease the underlying membrane potential (i.e. the resting potential becomes more negative). While tDCS is a promising adjunctive treatment of auditory hallucinations and negative symptoms in schizophrenia, less is known about its role in treating hallucinations overall. To date, no study has non-invasively stimulated the rSTS with tDCS in psychosis and examined its effects on hallucinations. However, there are studies in healthy volunteers showing that anodal stimulation to the STS resulted in increased auditory false perceptions, while cathodal stimulation decreased false perceptions and was lower than the sham condition. Taken together, the recent lesion network mapping identifying the rSTS as a major source of hallucinations combined with prior studies showing that the rSTS is associated with hallucinations suggest that it may be possible to alleviate hallucinations by designing a tDCS protocol that targets the rSTS with cathodal stimulation. Technological advances in noninvasive neuromodulation and electrical field modeling further allow us to create a tDCS protocol specifically guided by the results of lesion network mapping studies with high spatial resolution.
- Conditions
- Hallucinations, Auditory, Psychosis
- Being tested
- Transcranial Electrical Stimulation
- Keywords
- Transcranial Electrical Stimulation, Electroencephalography
- Medical subject headings
- Hallucinations, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Electrical StimulationDevice
Transcranial electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation with TDCS | Experimental | 10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions). Receives: Device: Transcranial Electrical Stimulation |
| SHAM Stimulation | Sham comparator | 10 passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions). Receives: Device: Transcranial Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Measured: Change from baseline to day 5
Positive and Negative Syndrome Scale (PANSS)
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Measured: Change from baseline to month follow-up
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
Measured: Change from baseline to day 5
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
Measured: Change from baseline to month follow-up
7-item Auditory Hallucinations Rating Scale (AHRS)
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
Measured: Change from baseline to day 5
7-item Auditory Hallucinations Rating Scale (AHRS)
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
Measured: Change from baseline to month follow-up
Secondary outcomes (22)
Auditory Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10*log10) at a particular auditory frequency of interest.
Measured: Change from baseline to day 5
Auditory Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10*log10) at a particular auditory frequency of interest.
Measured: Change from baseline to month follow-up
Steady State Visual Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10*log10) at a particular visual frequency of interest.
Measured: Change from baseline to day 5
Steady State Visual Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10*log10) at a particular visual frequency of interest.
Measured: Change from baseline to month follow-up
Cross Modal Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10*log10) at a particular visual/auditory frequency of interest.
Measured: Change from baseline to day 5
Cross Modal Steady State Evoked Potential
Raw data was cleaned for artifacts (excessive noise) and segmented in cleaned epochs based on stimulus onset. Post preprocessing stages, the signal reported was derived from using a time-frequency transformation and analysis, which is conceptualized as oscillatory power in decibels (10*log10) at a particular visual/auditory frequency of interest.
Measured: Change from baseline to month follow-up
Resting State EEG
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Measured: Change from baseline to 5 day
Resting State EEG
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Measured: Change from baseline to month follow-up
Biological Motion
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion.
Measured: Change from baseline to 5 day
Biological Motion
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli. 20 trials are presented. Higher scores (0-100%) indicate a better ability to detect motion.
Measured: Change from baseline to month follow-up
Neurological Evaluation Scale; Sensory Integration
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
Measured: Change from baseline to 5 day
Neurological Evaluation Scale; Sensory Integration
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
Measured: Change from baseline to month follow-up
Global Assessment of Function (GAF)
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
Measured: Change from baseline to day 5
Global Assessment of Function (GAF)
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
Measured: Change from baseline to month follow-up
Montgomery-Asberg Depression Rating Scale (MADRS)
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
Measured: Change from baseline to 5 day
Montgomery-Asberg Depression Rating Scale (MADRS)
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
Measured: Change from baseline to month follow-up
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Measured: Change from baseline to 5 day
Young Mania Rating Scale (YMRS)
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Measured: Change from baseline to month follow-up
Brief Assessment of Cognition (BACS)
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task.
Measured: Change from baseline to 5 day
Brief Assessment of Cognition (BACS)
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency. Higher scores indicate greater cognitive ability on a given task.
Measured: Change from baseline to month follow-up
Symptom Checklist-90
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms. Total score range 0 to 360
Measured: Change from baseline to 5 day
Symptom Checklist-90
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms.Total score range 0 to 360.
Measured: Change from baseline to month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallucinations, AuditoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Lizano, Beth Israel Deaconess Medical Center
- Investigators
- Paulo Lizano, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165654
- Sponsor's protocol ID
- 2019P001016X
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2021
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hallucinations by Targeting the Right Superior Temporal Sulcus With Electrical Stimulation
- ClinicalTrials.gov ID
- NCT05165654
- Acronym / sponsor ID
- 2019P001016X
- Conditions
- Hallucinations, Auditory, Psychosis
- Keywords
- Transcranial Electrical Stimulation, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hallucinations are a core diagnostic feature of psychotic disorders. They involve different sensory modalities, including auditory, visual, olfactory, tactile, and gustatory hallucinations, among others. Hallucinations occur in multiple different neurological and psychiatric illnesses and can be refractory to existing treatments. Auditory hallucinations and visual hallucinations are found across diagnostic categories of psychotic disorders (schizophrenia, schizoaffective, bipolar disorder). Despite visual hallucinations being approximately half as frequent as auditory hallucinations, they almost always co-occur with auditory hallucinations, and are linked to a more severe psychopathological profile. Auditory and visual hallucinations at baseline also predict higher disability, risk of relapse and duration of psychosis after 1 and 2 years, especially when they occur in combination. Using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions connected to the right superior temporal sulcus (rSTS) plays a causal role in the development of hallucinations. The rSTS receives convergent somatosensory, auditory, and visual inputs, and is regarded as a site for multimodal sensory integration. Here the investigators aim to answer the question whether noninvasive brain stimulation when optimally targeted to the rSTS can improve brain activity, sensory integration, and hallucinations.
Detailed description
Functional neuroimaging studies have identified neural correlates of hallucinations across multiple brain regions. Some studies suggest a common neuroanatomical substrate independent of the sensory modality, while others suggest different neural correlates for different types of hallucinations. However, whether these neuroimaging findings represented a cause, consequence or epiphenomenon of hallucinations was unclear until recently. Using lesion network mapping, researchers demonstrated that focal brain lesions play a causal role in the development of hallucinations and can occur in different brain locations, both inside and outside sensory pathway, and that greater than 90% of lesion locations causing hallucinations are negatively connected to the right superior temporal sulcus (rSTS). The rSTS is known to play a role in social cognition, biological motion, audiovisual integration, and speech. Hence, when spontaneous activity decreases at lesion locations causing hallucinations, spontaneous activity in the rSTS increases, the exact pattern thought to predispose to hallucinations. Additionally, functional connectivity within this region is abnormal in patients with visual and auditory hallucinations. Therefore, the association between rSTS connectivity and hallucinations would suggest this region may be optimal for modulation via non-invasive brain stimulation.
One method by which cortical excitability can be altered is with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. High definition tDCS (HD-tDCS) is a refined version of tDCS with improved spatial precision of cortical stimulation. This involves the application of a weak electrical current (1-2 mA) delivered to the brain via scalp electrodes. tDCS can modulate cortical excitability, where anodal stimulation tends to increase (i.e. the resting potential becomes less negative) and cathodal stimulation tends to decrease the underlying membrane potential (i.e. the resting potential becomes more negative). While tDCS is a promising adjunctive treatment of auditory hallucinations and negative symptoms in schizophrenia, less is known about its role in treating hallucinations overall. To date, no study has non-invasively stimulated the rSTS with tDCS in psychosis and examined its effects on hallucinations. However, there are studies in healthy volunteers showing that anodal stimulation to the STS resulted in increased auditory false perceptions, while cathodal stimulation decreased false perceptions and was lower than the sham condition. Taken together, the recent lesion network mapping identifying the rSTS as a major source of hallucinations combined with prior studies showing that the rSTS is associated with hallucinations suggest that it may be possible to alleviate hallucinations by designing a tDCS protocol that targets the rSTS with cathodal stimulation. Technological advances in noninvasive neuromodulation and electrical field modeling further allow us to create a tDCS protocol specifically guided by the results of lesion network mapping studies with high spatial resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation with TDCS | Experimental | Device: Transcranial Electrical Stimulation10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions). |
| SHAM Stimulation | Sham comparator | Device: Transcranial Electrical Stimulation10 passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 years of age
- Proficient in English
- Able to give informed consent
- Actively experiencing hallucinations (tactile, auditory, visual, etc.)
- Has not recently participated in tES/TMS treatments
Key exclusion criteria (6 listed)
- Substance abuse or dependence (w/in past 6 months)
- Those who are pregnant/breastfeeding
- History of head injury with > 15 minutes of loss of consciousness/mal sequelae
- DSM-V intellectual disability
- Having a non-removable ferromagnetic metal within the body (particularly in the head)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Electrical StimulationTranscranial electrical stimulation | Device | Active Stimulation with TDCS, SHAM Stimulation |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline to day 5
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline to month follow-up
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Time frame: Change from baseline to day 5
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Time frame: Change from baseline to month follow-up
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms. Total quantitative score (min = 0; max = 14).
7-item Auditory Hallucinations Rating Scale (AHRS)
Time frame: Change from baseline to day 5
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
7-item Auditory Hallucinations Rating Scale (AHRS)
Time frame: Change from baseline to month follow-up
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms. Total score (0-41).
22 secondary outcomes
Auditory Steady State Evoked Potential
Time frame: Change from baseline to day 5
Auditory Steady State Evoked Potential
Time frame: Change from baseline to month follow-up
Steady State Visual Evoked Potential
Time frame: Change from baseline to day 5
Steady State Visual Evoked Potential
Time frame: Change from baseline to month follow-up
Cross Modal Steady State Evoked Potential
Time frame: Change from baseline to day 5
Cross Modal Steady State Evoked Potential
Time frame: Change from baseline to month follow-up
Resting State EEG
Time frame: Change from baseline to 5 day
Resting State EEG
Time frame: Change from baseline to month follow-up
Biological Motion
Time frame: Change from baseline to 5 day
Biological Motion
Time frame: Change from baseline to month follow-up
Neurological Evaluation Scale; Sensory Integration
Time frame: Change from baseline to 5 day
Neurological Evaluation Scale; Sensory Integration
Time frame: Change from baseline to month follow-up
Global Assessment of Function (GAF)
Time frame: Change from baseline to day 5
Global Assessment of Function (GAF)
Time frame: Change from baseline to month follow-up
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Change from baseline to 5 day
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Change from baseline to month follow-up
Young Mania Rating Scale (YMRS)
Time frame: Change from baseline to 5 day
Young Mania Rating Scale (YMRS)
Time frame: Change from baseline to month follow-up
Brief Assessment of Cognition (BACS)
Time frame: Change from baseline to 5 day
Brief Assessment of Cognition (BACS)
Time frame: Change from baseline to month follow-up
Symptom Checklist-90
Time frame: Change from baseline to 5 day
Symptom Checklist-90
Time frame: Change from baseline to month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Lizano, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Electrical Stimulation in people with Hallucinations, Auditory and Psychosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: Change from baseline to day 5). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.