Clinical trial NCT05053451: Brain Stimulation, Clinical Symptoms and Cognition
Official title: Transcranial Direct Current Stimulation (tDCS) Studies of Auditory Hallucinations, Negative Symptoms and Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
EEG
tDCS
dorsolateral prefrontal cortex
temporoparietal junction
cognitive control
auditory hallucinations
transcranial direct current stimulation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptom Severity of Auditory Hallucinations
timeFrame: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
measure: Change in Symptom Severity of Negative Symptoms
timeFrame: Assessment begins with the initial baseline interview and concludes after a 2-week follow-up assessment using the same clinical measures.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Imaging Research Center
state: California
Study officials:
References: