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Completed

NCT Number: NCT05165654

Improving Hallucinations by Targeting the rSTS With tES

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.

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Key information

Conditions

Hallucinations, Auditory Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Transcranial Electrical Stimulation

Device

Transcranial electrical stimulation

Primary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Secondary outcomes

  1. Auditory Steady State Evoked Potential

    Time frame: 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.

  2. Auditory Steady State Evoked Potential

    Time frame: 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.

  3. Steady State Visual Evoked Potential

    Time frame: 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.

  4. Steady State Visual Evoked Potential

    Time frame: 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.

  5. Cross Modal Steady State Evoked Potential

    Time frame: 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.

  6. Cross Modal Steady State Evoked Potential

    Time frame: 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.

  7. Resting State EEG

    Time frame: Change from baseline to 5 day

    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.

  8. Resting State EEG

    Time frame: Change from baseline to month follow-up

    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.

  9. Biological Motion

    Time frame: Change from baseline to 5 day

    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.

  10. Biological Motion

    Time frame: Change from baseline to month follow-up

    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.

  11. Neurological Evaluation Scale; Sensory Integration

    Time frame: Change from baseline to 5 day

    Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns

  12. Neurological Evaluation Scale; Sensory Integration

    Time frame: Change from baseline to month follow-up

    Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns

  13. Global Assessment of Function (GAF)

    Time frame: Change from baseline to day 5

    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

  14. Global Assessment of Function (GAF)

    Time frame: Change from baseline to month follow-up

    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

  15. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Change from baseline to 5 day

    Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms

  16. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Change from baseline to month follow-up

    Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms

  17. Young Mania Rating Scale (YMRS)

    Time frame: Change from baseline to 5 day

    Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms

  18. Young Mania Rating Scale (YMRS)

    Time frame: Change from baseline to month follow-up

    Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms

  19. Brief Assessment of Cognition (BACS)

    Time frame: Change from baseline to 5 day

    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.

  20. Brief Assessment of Cognition (BACS)

    Time frame: Change from baseline to month follow-up

    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.

  21. Symptom Checklist-90

    Time frame: Change from baseline to 5 day

    Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms. Total score range 0 to 360

  22. Symptom Checklist-90

    Time frame: Change from baseline to month follow-up

    Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms.Total score range 0 to 360.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Improving Hallucinations by Targeting the Right Superior Temporal Sulcus With Electrical Stimulation

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2021
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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