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Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia

Transcranial Direct Current Stimulation (tDCS) Studies of Cognition, Oscillations and GABA Levels in Schizophrenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04267003
Enrollment
160
Registered
2020-02-12
Start date
2020-01-09
Completion date
2026-08-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, EEG, tDCS, dorsolateral prefrontal cortex, cognitive control, transcranial direct current stimulation, GABA, MR spectroscopy

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.

Interventions

DEVICETranscranial Direct Current Stimulation

In tDCS, saline-soaked electrodes are temporary 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). To control for placebo effects, the study will utilize a sham stimulation protocol that consists of very brief constant stimulation (\~1 minute). Subjects usually cannot discern the difference between the sham and experimental stimulation protocols due to habituation.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 47 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
EEG Correlates of Language and Cognitive ControlAssessment will begin immediately following stimulation and last for about 1.5 hours.Electrophysiological data recorded during completion of cognitive control tasks. We will measure oscillatory activity from 3-80 Hz.
Behavioral ResponseAssessment will begin immediately following stimulation and last for about 1.5 hours.We will assess performance on the Dot Pattern Expectancy (DPX) task (error rates).

Countries

United States

Contacts

CONTACTMolly A Bainbridge
mebainbridge@ucdavis.edu(916) 734-8779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026