Brain Stimulation, Clinical Symptoms and Cognition

NCT05053451 | Completed FDA Device

• 1 other identifier: 1607658
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

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

Study Arms (1)

dlPFC/TPJ Stimulation + Rest

EXPERIMENTAL

20 minutes of 2 mA direct current stimulation during rest.

Device: Transcranial Direct Current Stimulation

Interventions

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.

dlPFC/TPJ Stimulation + Rest

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Imaging Research Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 22, 2021
• Study Start: September 14, 2021
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: May 17, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)