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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04267003
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 47 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Direct Current Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2020
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: DLPFC Stimulation + Task
    Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during cognitive task completion.
  • Experimental: DLPFC Stimulation + Rest
    Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex during rest.
  • Sham Comparator: Sham Stimulation + Task
    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.
  • Sham Comparator: Sham Stimulation + Rest
    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.

Primary Outcome Measure

EEG Correlates of Language and Cognitive Control [ Time Frame: Assessment will begin immediately following stimulation and last for about 1.5 hours. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Imaging Research CenterSacramentoCalifornia95817
Molly Bainbridge
916-734-3749
Cameron Carter, M.D. (PRINCIPAL_INVESTIGATOR)

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