Brain Stimulation, Clinical Symptoms and Cognition

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053451
• Other study ID #: 1607658
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: April 10, 2024

Study information

• Verified date: April 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Imaging Research Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.