Improving Hallucinations by Targeting the rSTS With tES

NCT05165654 | Completed Results FDA Device

• 1 other identifier: 2019P001016X
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hallucinations, Auditory; Psychosis

Keywords

Transcranial Electrical Stimulation; Electroencephalography

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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).

  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).

  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).

  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).

  Change from baseline to month follow-up

Secondary Outcomes (22)

• Auditory Steady State Evoked Potential

  Change from baseline to day 5

• Auditory Steady State Evoked Potential

  Change from baseline to month follow-up

• Steady State Visual Evoked Potential

  Change from baseline to day 5

• Steady State Visual Evoked Potential

  Change from baseline to month follow-up

• Cross Modal Steady State Evoked Potential

  Change from baseline to day 5

Study Arms (2)

Active Stimulation with TDCS

EXPERIMENTAL

10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).

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).

Device: Transcranial Electrical Stimulation

Interventions

Transcranial Electrical Stimulation DEVICE

Transcranial electrical stimulation

Active Stimulation with TDCS; SHAM Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hallucinations; Psychotic Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Small numbers of subjects analyzed due to funding for a pilot study. There was a technical problem related to the NES task which resulted in the data not being collected after the first subject.

Results Point of Contact

• Title: Dr. Paulo Lizano
• Organization: BIDMC

lizanopl@gmail.com

202-776-6708

Study Officials

• Paulo Lizano, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 21, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 23, 2025
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)