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CompletedNCT05053451Updated May 17, 2024

Brain Stimulation, Clinical Symptoms and Cognition

An interventional study of Transcranial Direct Current Stimulation in Schizophrenia, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to test the impact of non-invasive brain stimulation, transcranial direct current stimulation (tDCS), on auditory hallucinations, negative symptoms and cognition in schizophrenia. Clinical measures will be used to assess clinical symptoms and cognitive performance to test the hypothesis that a course of tDCS can reduce auditory hallucinations and negative symptoms in schizophrenia.

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Conditions studied

  • Schizophrenia

Keywords

  • schizophrenia
  • EEG
  • tDCS
  • dorsolateral prefrontal cortex
  • temporoparietal junction
  • cognitive control
  • auditory hallucinations
  • transcranial direct current stimulation
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In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 5 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks.
  • All subjects must have the ability to give valid informed consent.
  • No children under the age of 18 will be recruited.
  • Diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
  • Stable outpatient or partial hospital status
  • Normal IQ (>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test)

Exclusion criteria

Exclusion Criteria:

  • Pacemakers
  • Implanted electrical (brain and spinal) stimulators
  • Implanted defibrillator
  • Metallic implants
  • Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
  • Hair styles hindering the placement of electrodes
  • Cranial pathologies
  • Head trauma
  • Epilepsy
  • Mental retardation
  • Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism)
  • Uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance)
  • Pregnancy
  • Substance dependence in the past six months
  • Substance abuse in the past month
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    dlPFC/TPJ Stimulation + Rest

    20 minutes of 2 mA direct current stimulation during rest.

    Device: Transcranial Direct Current Stimulation

Interventions

  • DeviceTranscranial Direct Current Stimulation

    In tDCS, saline-soaked electrodes are temporarily affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (20 minutes) to stimulate the targeted brain area (e.g. the DLPFC, TPJ, Occipital Cortex) depending on the phase of the study.

06

What researchers measure

Primary outcomes

  1. Change in Symptom Severity of Auditory Hallucinations

    Participants will undergo diagnostic (clinical) interviews to rate their symptom severity using measures including, but not limited to, the Brief Psychiatric Rating Scale (rated 1-7, with a high rating indicating more severe symptoms), the Scale of the Assessment of Positive Symptoms (rated 0-5, with a high rating indicating more severe symptoms), and the Scale for the Assessment or Negative Symptoms (rated 0-5, with a high rating indicating more severe symptoms).

    Time frame: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.

  2. Change in Symptom Severity of Negative Symptoms

    Participants will undergo diagnostic (clinical) interviews to rate their symptom severity using measures including, but not limited to, the Brief Psychiatric Rating Scale (rated 1-7, with a high rating indicating more severe symptoms), the Scale of the Assessment of Positive Symptoms (rated 0-5, with a high rating indicating more severe symptoms), and the Scale for the Assessment or Negative Symptoms (rated 0-5, with a high rating indicating more severe symptoms).

    Time frame: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.

07

Study locations

1 site
  • Imaging Research Center
    Sacramento, California 95817, United States
08

References and documents

Individual participant data

Plan to share: Yes — Select data from this study may be submitted to the National Institute of Mental Health Data Archive (NDA). NDA is a data repository run by the National Institute of Mental Health (NIMH) that allows researchers studying mental illness to collect and share de-identified information with each other. The data repository is accessible only to qualified investigators. All subject data will be de-identified (subject names will not be used) and each subject will have a separate identifier called a Global Unique Identifier (GUID) to remove any possibility that "the identities of the subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users." (45 CFR, 46.102).

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05053451
Responsible party
Sponsor
First posted
Sep 22, 2021
Start date
Sep 14, 2021
Primary completion
Apr 10, 2024
Completion
Apr 10, 2024
Last update
May 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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