Brain Stimulation, Clinical Symptoms and Cognition

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imaging Research Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Transcranial Direct Current Stimulation

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.

Primary outcomes

Change in Symptom Severity of Auditory Hallucinations

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

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).
Change in Symptom Severity of Negative Symptoms

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

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).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) Studies of Auditory Hallucinations, Negative Symptoms and Cognition in Schizophrenia

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Sep 22, 2021
Registry last updated: May 17, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed