An interventional study of Transcranial Electrical Stimulation in Hallucinations, Auditory and Psychosis, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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.
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.
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 →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
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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.
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.
10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
Device: Transcranial Electrical Stimulation
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).
Device: Transcranial Electrical Stimulation
Transcranial electrical stimulation
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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline to month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Change from baseline to month follow-up
Participants were recruited through patient conversations and advertisements.
| Milestone | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Started | 6 | 6 |
| Baseline | 6 | 6 |
| Day 5 | 6 | 6 |
| 1 month | 5 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
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
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 60.5 (47.75 to 77) | 60 (53.75 to 69.25) |
| Day 5 | 56 (44.25 to 75.25) | 63 (59 to 70) |
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
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 60.5 (47.75 to 77) | 60 (53.75 to 69.25) |
| 1 Month | 58.5 (47 to 67.75) | 70.5 (60.25 to 83.75) |
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).
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 1.85 (1.725 to 2.025) | 1.9 (1.85 to 2.0125) |
| Day 5 | 1.3 (1.25 to 1.35) | 2 (1.8 to 2.2) |
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).
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 1.85 (1.725 to 2.025) | 1.9 (1.85 to 2.0125) |
| 1 Month | 1.4 (1.05 to 1.6875) | 2.35 (2.05 to 2.4) |
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).
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 0 (0 to 0) | 8 (0 to 19.75) |
| Day 5 | 0 (0 to 0) | 6 (0 to 22.5) |
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).
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 0 (0 to 0) | 8 (0 to 19.75) |
| 1 Month | 0 (0 to 0) | 6 (0 to 23.25) |
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.
| decibels | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 0.369044853 (0.091708253 to 0.624277228) | 0.434681797 (0.16328823 to 0.643059721) |
| Day | 0.259385513 (0.190658708 to 0.314372544) | 0.257550439 (-0.046862077 to 0.352363789) |
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.
| decibels | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 0.369044853 (0.091708253 to 0.624277228) | 0.434681797 (0.16328823 to 0.643059721) |
| 1 Month | 0.307252913 (0.241709825 to 0.677070695) | 0.221649958 (-0.021732331 to 0.406676752) |
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.
| decibels | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | -0.62131125 (-0.726391384 to -0.074934424) | -0.046333327 (-0.103732736 to 0.052670088) |
| Day 5 | -0.101487523 (-0.548558447 to 0.099856615) | -0.061733608 (-0.291644849 to 0.143966164) |
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.
| decibels | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | -0.62131125 (-0.726391384 to -0.074934424) | -0.046333327 (-0.103732736 to 0.052670088) |
| 1 Month | 0.276320034 (0.09372428 to 0.34434154) | -0.342125912 (-0.525993493 to -0.203782791) |
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.
| decibels | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | -0.129873057 (-0.351085988 to -0.039036888) | -0.225582699 (-0.369160721 to -0.084290267) |
| Day 5 | -0.227227968 (-0.314087578 to -0.209605677) | -0.309958523 (-0.479995017 to -0.140836317) |
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.
| decibels | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | -0.129873057 (-0.351085988 to -0.039036888) | -0.225582699 (-0.369160721 to -0.084290267) |
| 1 Month | -0.372064254 (-0.395091449 to -0.264603929) | -0.370288832 (-0.480430263 to -0.146267599) |
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.
| microvolts | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline Delta/Theta Range (1-8hz) | -6.067479336 (-8.358364857 to -5.444418054) | -9.836502863 (-10.87640284 to -6.060701682) |
| Day 5 Delta/Theta Range (1-8hz) | -6.538377742 (-8.949555683 to -5.160262915) | -8.837371992 (-11.64394669 to -7.549197399) |
| Baseline Alpha (8-12hz) | -7.920960953 (-10.83320875 to -7.295414497) | -11.66579035 (-13.69578824 to -7.820418988) |
| Day 5 Alpha (8-12hz) | -7.433306198 (-10.21438969 to -7.043908117) | -10.07675116 (-13.61574437 to -7.162213165) |
| Baseline Beta (13-30hz) | -15.99107017 (-16.44864468 to -15.41891723) | -17.88706322 (-18.60085714 to -16.64276514) |
| Day 5 Beta (13-30hz) | -15.97882887 (-16.30148928 to -15.67218914) | -17.45169236 (-17.80617123 to -15.82596502) |
| Baseline Gamma (30-55hz) | -22.64365385 (-23.36454231 to -21.38378251) | -22.02556837 (-24.09400191 to -20.51039388) |
| Day 5 Gamma (30-55hz) | -23.79503055 (-24.38033537 to -20.99613743) | -22.638985 (-23.25493645 to -21.12844812) |
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.
| microvolts | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline Delta/Theta Range (1-8hz) | -6.067479336 (-8.358364857 to -5.444418054) | -9.836502863 (-10.87640284 to -6.060701682) |
| 1 Month Delta/Theta Range (1-8hz) | -5.891239776 (-7.30798828 to -4.582039071) | -8.925939219 (-10.09990467 to -7.862654867) |
| Baseline Alpha (8-12hz) | -7.920960953 (-10.83320875 to -7.295414497) | -11.66579035 (-13.69578824 to -7.820418988) |
| 1 Month Alpha (8-12hz) | -9.390036281 (-10.94620211 to -8.24923518) | -7.367402407 (-9.002447243 to -7.084971382) |
| Baseline Beta (12-30hz) | -15.99107017 (-16.44864468 to -15.41891723) | -17.88706322 (-18.60085714 to -16.64276514) |
| 1 Month Beta (13-30hz) | -16.0281252 (-17.60044849 to -15.79720705) | -16.27626797 (-18.23084259 to -15.95296812) |
| Baseline Gamma (30-55hz) | -22.64365385 (-23.36454231 to -21.38378251) | -22.02556837 (-24.09400191 to -20.51039388) |
| 1 Month Gamma (30-55hz) | -23.89591029 (-24.94829518 to -22.12361733) | -22.95515728 (-24.30097235 to -22.21405322) |
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.
| percentage correct | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 87.5 (76.25 to 98.75) | 85 (61.25 to 93.75) |
| Day 5 | 95 (87.5 to 98.75) | 72.5 (51.25 to 93.75) |
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.
| percentage correct | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 87.5 (76.25 to 98.75) | 85 (61.25 to 93.75) |
| 1 Month | 95 (87.5 to 95) | 85 (67.5 to 95) |
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
No measurements were reported for this outcome.
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
No measurements were reported for this outcome.
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
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 60.5 (53.25 to 64) | 57.5 (43.75 to 60) |
| Day 5 | 60.5 (52.5 to 67.75) | 53 (42.75 to 58.75) |
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
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 60.5 (53.25 to 64) | 57.5 (43.75 to 60) |
| 1 Month | 61.5 (56.25 to 68.25) | 54 (51.5 to 59.5) |
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 7 (3.5 to 16.5) | 7.5 (4.75 to 10.25) |
| Day 5 | 6 (2.5 to 18.5) | 13.5 (5.5 to 20) |
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 7 (3.5 to 16.5) | 7.5 (4.75 to 10.25) |
| 1 Month | 5.5 (4.25 to 19.5) | 13 (10.5 to 15.5) |
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 2.25 (0.625 to 14) | 7 (3.625 to 11.875) |
| Day 5 | 1.25 (0.125 to 11.375) | 14 (6.375 to 14.875) |
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 2.25 (0.625 to 14) | 7 (3.625 to 11.875) |
| 1 Month | 2 (1.25 to 10.25) | 8.75 (5.25 to 14.875) |
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.
| z score on test | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 0.58 (-0.7075 to 1.005) | -0.8 (-1.5325 to -0.4275) |
| Day 5 | -0.15 (-1.355 to 0.5375) | -1.065 (-1.7775 to -0.5475) |
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.
| z score on test | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 0.58 (-0.7075 to 1.005) | -0.8 (-1.5325 to -0.4275) |
| 1 Month | -0.07 (-0.5775 to 0.7525) | -1.425 (-1.825 to -0.8225) |
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms. Total score range 0 to 360
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 56.5 (21.75 to 119.75) | 81.5 (56.5 to 95.25) |
| Day 5 | 33 (9.25 to 56) | 84.5 (69.25 to 95.25) |
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms.Total score range 0 to 360.
| score on a scale | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| Baseline | 56.5 (21.75 to 119.75) | 81.5 (56.5 to 95.25) |
| 1 Month | 42 (16.5 to 102) | 95.5 (79.5 to 124.25) |
Collected over Up to 1 month period after study participation. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Stimulation With TDCS | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| SHAM Stimulation | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Active Stimulation With TDCS | SHAM Stimulation |
|---|---|---|
| TinnitusEar and labyrinth disorders | 0/6 | 1/6 |
| LightheadnessNervous system disorders | 0/6 | 1/6 |
| Age, Continuous(years) | Active Stimulation With TDCS | SHAM Stimulation | Total |
|---|---|---|---|
| Mean | 36.7 ± 8.3 | 37.5 ± 14.8 | 37.1 ± 11.5 |
| Sex: Female, Male(Participants) | Active Stimulation With TDCS | SHAM Stimulation | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Active Stimulation With TDCS | SHAM Stimulation | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 5 | 6 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active Stimulation With TDCS | SHAM Stimulation | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
| Prior/Current Hallucinations(Participants) | Active Stimulation With TDCS | SHAM Stimulation | Total |
|---|---|---|---|
| Count of participants | 6 | 6 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2021 to primary completion in Jun 2025, 43 months.
Results were first posted in Sep 2025, 3 months after primary completion.
Of 53 non-industry interventional studies with no phase under Hallucinations, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 56. This study's 43 months is above that.
Counting every sponsor, half of 53 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center →