NCT05165654

Improving Hallucinations by Targeting the rSTS With tES

Completed NA Results posted Last updated 17 September 2025

What this trial tests

NA trial testing Transcranial Electrical Stimulation in Hallucinations, Auditory in 12 participants. Completed in 23 June 2025.

Timeline

1 November 2021

Primary endpoint
1 June 2025

23 June 2025

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	1 November 2021
Primary completion	1 June 2025
Estimated completion	23 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Transcranial Electrical Stimulation

Conditions studied

• Hallucinations, Auditory — all drugs for Hallucinations, Auditory →
• Psychosis — all drugs for Psychosis →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

Adults 18 to 50, any sex, with Hallucinations, Auditory or Psychosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Positive and Negative Syndrome Scale (PANSS) Primary · 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

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	60.5	47.75 – 77
SHAM Stimulation	60	53.75 – 69.25

Day 5

Group	Value	95% CI
Active Stimulation With TDCS	56	44.25 – 75.25
SHAM Stimulation	63	59 – 70

Positive and Negative Syndrome Scale (PANSS) Primary · 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

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	60.5	47.75 – 77
SHAM Stimulation	60	53.75 – 69.25

1 Month

Group	Value	95% CI
Active Stimulation With TDCS	58.5	47 – 67.75
SHAM Stimulation	70.5	60.25 – 83.75

University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) Primary · 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).

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	1.85	1.725 – 2.025
SHAM Stimulation	1.9	1.85 – 2.0125

Day 5

Group	Value	95% CI
Active Stimulation With TDCS	1.3	1.25 – 1.35
SHAM Stimulation	2	1.8 – 2.2

University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ) Primary · 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).

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	1.85	1.725 – 2.025
SHAM Stimulation	1.9	1.85 – 2.0125

1 Month

Group	Value	95% CI
Active Stimulation With TDCS	1.4	1.05 – 1.6875
SHAM Stimulation	2.35	2.05 – 2.4

7-item Auditory Hallucinations Rating Scale (AHRS) Primary · 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).

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	0	0 – 0
SHAM Stimulation	8	0 – 19.75

Day 5

Group	Value	95% CI
Active Stimulation With TDCS	0	0 – 0
SHAM Stimulation	6	0 – 22.5

7-item Auditory Hallucinations Rating Scale (AHRS) Primary · 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).

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	0	0 – 0
SHAM Stimulation	8	0 – 19.75

1 Month

Group	Value	95% CI
Active Stimulation With TDCS	0	0 – 0
SHAM Stimulation	6	0 – 23.25

Auditory Steady State Evoked Potential Secondary · Change from baseline to day 5

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.

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	0.369044853	0.091708253 – 0.624277228
SHAM Stimulation	0.434681797	0.16328823 – 0.643059721

Day

Group	Value	95% CI
Active Stimulation With TDCS	0.259385513	0.190658708 – 0.314372544
SHAM Stimulation	0.257550439	-0.046862077 – 0.352363789

Auditory Steady State Evoked Potential Secondary · Change from baseline to month follow-up

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.

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	0.369044853	0.091708253 – 0.624277228
SHAM Stimulation	0.434681797	0.16328823 – 0.643059721

1 Month

Group	Value	95% CI
Active Stimulation With TDCS	0.307252913	0.241709825 – 0.677070695
SHAM Stimulation	0.221649958	-0.021732331 – 0.406676752

Steady State Visual Evoked Potential Secondary · Change from baseline to day 5

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.

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	-0.62131125	-0.726391384 – -0.074934424
SHAM Stimulation	-0.046333327	-0.103732736 – 0.052670088

Day 5

Group	Value	95% CI
Active Stimulation With TDCS	-0.101487523	-0.548558447 – 0.099856615
SHAM Stimulation	-0.061733608	-0.291644849 – 0.143966164

Steady State Visual Evoked Potential Secondary · Change from baseline to month follow-up

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.

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	-0.62131125	-0.726391384 – -0.074934424
SHAM Stimulation	-0.046333327	-0.103732736 – 0.052670088

1 Month

Group	Value	95% CI
Active Stimulation With TDCS	0.276320034	0.09372428 – 0.34434154
SHAM Stimulation	-0.342125912	-0.525993493 – -0.203782791

Cross Modal Steady State Evoked Potential Secondary · Change from baseline to day 5

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.

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	-0.129873057	-0.351085988 – -0.039036888
SHAM Stimulation	-0.225582699	-0.369160721 – -0.084290267

Day 5

Group	Value	95% CI
Active Stimulation With TDCS	-0.227227968	-0.314087578 – -0.209605677
SHAM Stimulation	-0.309958523	-0.479995017 – -0.140836317

Cross Modal Steady State Evoked Potential Secondary · Change from baseline to month follow-up

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.

Baseline

Group	Value	95% CI
Active Stimulation With TDCS	-0.129873057	-0.351085988 – -0.039036888
SHAM Stimulation	-0.225582699	-0.369160721 – -0.084290267

1 Month

Group	Value	95% CI
Active Stimulation With TDCS	-0.372064254	-0.395091449 – -0.264603929
SHAM Stimulation	-0.370288832	-0.480430263 – -0.146267599

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 month period after study participation. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Stimulation With TDCS

Serious: 0/6 (0%)

Deaths: 0/6

SHAM Stimulation

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (2 terms — click to expand)

Reaction	System	Active Stimulation With TDCS	SHAM Stimulation
Tinnitus	Ear and labyrinth disorders	—	—
Lightheadness	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT05165654 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.