Clinical trial NCT04267003: Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia
Official title: Transcranial Direct Current Stimulation (tDCS) Studies of Cognition, Oscillations and GABA Levels in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
EEG
tDCS
dorsolateral prefrontal cortex
cognitive control
transcranial direct current stimulation
GABA
MR spectroscopy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: People with schizophrenia often have problems with attention, learning and memory and other cognitive abilities that interfere with their work and school performance. Unfortunately, even our best treatments often do not significantly reduce these cognitive problems. The current study investigates whether or not delivering a very small electrical current to people's foreheads (called, transcranial direct current stimulation; (tDCS)) might improve functioning in the front part of the brain and reduce these cognitive problems in people with schizophrenia. tDCS is non-invasive and has been shown to improve cognitive functioning in some preliminary studies. The current study will investigate whether giving tDCS during a task is more effective than giving it during rest (Aim 1), whether delivery of tDCS to the front of the head is more effective than delivery to the back of the head (Aim 2), and whether tDCS delivery will alter levels of a major inhibitory neurotransmitter in the brain (GABA; Aim 3) that is important to cognitive functioning and may be disrupted in people with schizophrenia. Although this study is not intended to diagnose, cure or treat schizophrenia or any other disease, if results are positive it will encourage future large-scale studies to determine if tDCS can become an effective treatment for cognitive problems in people with 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.

Inclusion Criteria for Patients with Schizophrenia Only:

* Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
* No medication changes in the prior month
* No medication changes anticipated in the upcoming month
* Stable outpatient or partial hospital status
* Normal IQ (\>70; IQ will be measured by administering the Wechsler Abbreviated Scale of
* Intelligence (WASI) test)
* Must not be currently taking the antipsychotic clozapine

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: EEG Correlates of Language and Cognitive Control
timeFrame: Assessment will begin immediately following stimulation and last for about 1.5 hours.
measure: Behavioral Response
timeFrame: Assessment will begin immediately following stimulation and last for about 1.5 hours.
measure: Behavioral Response
timeFrame: Assessment will begin immediately following stimulation and last for about 1.5 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Imaging Research Center
state: California
Study officials:
References: