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Clinical Trials/NCT04267003
NCT04267003RecruitingNot Applicable

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

University of California, Davis1 site in 1 country160 target enrollmentStarted: January 9, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
160
Locations
1
Primary Endpoint
EEG Correlates of Language and Cognitive Control

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 47 Years (Adult)
Sex
All
Accepts 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
  • 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

Arms & Interventions

DLPFC Stimulation + Task

Experimental

Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during cognitive task completion.

Intervention: Transcranial Direct Current Stimulation (Device)

DLPFC Stimulation + Rest

Experimental

Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during rest.

Intervention: Transcranial Direct Current Stimulation (Device)

Sham Stimulation + Task

Sham Comparator

Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during cognitive task completion.

Intervention: Transcranial Direct Current Stimulation (Device)

Sham Stimulation + Rest

Sham Comparator

Placebo Comparator. 0.5-1 minutes of 2 mA direct current stimulation over dorsolateral prefrontal cortex followed by 19-19.5 minutes of sham stimulation, during rest.

Intervention: Transcranial Direct Current Stimulation (Device)

Outcomes

Primary Outcomes

EEG Correlates of Language and Cognitive Control

Time Frame: Assessment 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 Response

Time Frame: Assessment 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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