Brain Stimulation, Clinical Symptoms and Cognition

NCT ID: NCT05053451

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2024-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dlPFC/TPJ Stimulation + Rest

20 minutes of 2 mA direct current stimulation during rest.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

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.

Interventions

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Transcranial 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Imaging Research Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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1607658

Identifier Type: -

Identifier Source: org_study_id

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