Feasibility Electrical Stimulation Study for Visual Hallucinations

NCT04870710 | Completed Results FDA Device

• 2 other identifiers: 2019P001016UL1TR002541
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The visual system has increasingly been recognized as an important site of injury in patients with schizophrenia and other psychoses. Visual system alterations manifest as visual perceptual aberrations, deficits in visual processing, and visual hallucinations. These visual symptoms are associated with worse symptoms, poorer outcome and resistance to treatment. A recent study using brain lesion mapping of visual hallucinations and identified a causal location in the part of the brain that processes visual information (visual cortex). The association between visual cortex activation and visual hallucinations suggests that this region could be targeted using noninvasive brain stimulation. Two case studies have found that brain stimulation to the visual cortex improved visual hallucinations in treatment resistant patients with psychosis. While promising it is unclear whether these symptom reductions resulted from activity changes in the visual cortex or not. Here we aim to answer the question whether noninvasive brain stimulation when optimally targeted to the visual cortex can improve brain activity, visual processing and visual hallucinations. The knowledge gained from this study will contribute to the field of vision by providing a marker for clinical response and by personalizing treatment for patients with psychosis suffering from visual symptoms. This grant will allow us to set the foundation for a larger more targeted study utilizing noninvasive brain stimulation to improve visual symptoms in patients with psychosis.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (6)

• Steady State Visual Evoked Potential (ssVEP)

  Measuring the average evoked response potential amplitude change for P100 at Baseline, 5 day and 1 month visits. ssVEP was utilized to measure changes in electrical biomarkers of the early visual response. Stimuli consisted of 50 trials of a black and white square oscillating at 18.75 Hz in the subject's central, bilateral, left, or right visual field for 2000 ms (200 total trials pseudorandomly interleaved) with inter-trial intervals of 2.5 seconds.

  Measured at day 5 compared to day 0

• Steady State Visual Evoked Potential (ssVEP)

  Measuring the average evoked response potential amplitude change for P100 at Baseline, 5 day and 1 month visits. ssVEP was utilized to measure changes in electrical biomarkers of the early visual response. Stimuli consisted of 50 trials of a black and white square oscillating at 18.75 Hz in the subject's central, bilateral, left, or right visual field for 2000 ms (200 total trials pseudorandomly interleaved) with inter-trial intervals of 2.5 seconds.

  Measured at day 30 compared to day 0 and day 5

• Positive and Negative Syndrome Scale (PANSS)

  Measuring total psychosis symptoms score. PANSS is a clinician administered instrument which has 30 items measuring a range of symptoms which are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme). A total score ranges from 30-210 with higher scores indicate worsen symptoms. Subscales include, general, negative and positive symptom categories with higher scores indicate worsen symptoms. The range for the positive and negative Scales is 7-49, and the range for the general Psychopathology Scale is 16-112.

  Measured at day 5 compared to day 0

• Positive and Negative Syndrome Scale (PANSS)

  Measuring total psychosis symptoms score. PANSS is a clinician administered instrument which has 30 items measuring a range of symptoms which are rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme). A total score ranges from 30-210 with higher scores indicate worsen symptoms. Subscales include, general, negative and positive symptom categories with higher scores indicate worsen symptoms. The range for the positive and negative Scales is 7-49, and the range for the general Psychopathology Scale is 16-112.

  Measured at day 30 compared to day 0 and day 5

• Biological Motion

  Measuring the percent correct of detected motion. Biological motion perception was assessed using point-light animations (12 dots on the head and major joints of the body) walking either rightward or leftward. The target animation was embedded in a number of random-moving noise dots (24, 48, or 72) to manipulate the difficulty level of the task. Participants were asked to indicate the direction that the animation was walking towards. The task lasted for about 4 minutes.

  Measured at day 5 compared to day 0

• Biological Motion

  Measuring the percent correct of detected motion. Biological motion perception was assessed using point-light animations (12 dots on the head and major joints of the body) walking either rightward or leftward. The target animation was embedded in a number of random-moving noise dots (24, 48, or 72) to manipulate the difficulty level of the task. Participants were asked to indicate the direction that the animation was walking towards. The task lasted for about 4 minutes.

  Measured at day 30 compared to day 0 and day 5

Secondary Outcomes (10)

• International Affective Picture System (IAPS) Task

  Measured at day 5 compared to day 0

• International Affective Picture System (IAPS) Task

  Measured at day 30 compared to day 0 and day 5

• Velocity Discrimination

  Measured at day 5 compared to day 0

• Velocity Discrimination

  Measured at day 30 compared to day 0 and day 5

• Visual Spatial Working Memory

  Measured at day 5 compared to day 0

Study Arms (2)

cathodal transcranial direct current stimulation (tDCS)

EXPERIMENTAL

Two, twenty minute sessions of cathodal tDCS to the bilateral extrastriate visual cortex for 5 days (10 total sessions).

Device: transcranial electrical stimulation

Anodal transcranial alternating current stimulation (tACS)

EXPERIMENTAL

Two, twenty minute sessions of anodal tACS delta phase aligned for 5 days (10 total sessions).

Device: transcranial electrical stimulation

Interventions

transcranial electrical stimulation DEVICE

Electrical stimulation to the extrastriate visual cortex.

Anodal transcranial alternating current stimulation (tACS); cathodal transcranial direct current stimulation (tDCS)

Eligibility Criteria

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

You may qualify if:

• meet diagnostic criteria for schizophrenia, schizoaffective disorder, or psychotic bipolar disorder as verified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR) and consensus clinical diagnosis;
• had no changes to relevant anti-psychotic medications for a period of 1 month prior to participation;
• had a sufficient level of English to allow participation.

You may not qualify if:

• pregnant or breastfeeding women;
• Intelligence quotient \<60
• any major medical or neurologic
• diagnosis of substance abuse positive urine drug screen
• history of moderate-to-severe visual impairment secondary to glaucoma, cataract or macular degeneration
• serious medical illness or instability requiring hospitalization within the next year
• relevant skin allergies; metallic or electronic implants (e.g. pacemakers, brain stimulators).

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Raymond N, Reinhart RMG, Trotti R, Parker D, Grover S, Turkozer B, Sabatinelli D, Hegde R, Bannai D, Gandu S, Clementz B, Keshavan M, Lizano P. Efficacy and Tolerability of Lesion Network Guided Transcranial Electrical Stimulation in Outpatients with Psychosis Spectrum Illness: A Nonrandomized Controlled Trial. medRxiv [Preprint]. 2023 Apr 3:2023.03.31.23287980. doi: 10.1101/2023.03.31.23287980.

  PMID: 37066217 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Our main analysis included individuals with imputed values for follow up visits (1 individual for 1 month tDCS; 1 individual for 1 month tACS). Due to corona virus related regulations our recruitment was hindered and resulted in a small sample size. Individuals were recruited from a single site. Recruited individuals were mainly stable during their baseline clinical assessments.

Results Point of Contact

• Title: Dr. Paulo Lizano
• Organization: BIDMC

plizano@bidmc.harvard.edu

617-754-1227

Study Officials

• Paulo Lizano, MD,PhD

  Staff Physician/Scientist

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 3, 2021
• Study Start: October 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 2, 2022
• Last Updated: June 12, 2025
• Results First Posted: April 21, 2023

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)