Clinical trial NCT03077347: The Effects of tDCS on the Neuronal Mechanisms of Cognitive Control in Schizophrenia
Official title: The Effects of Transcranial Direct Current Stimulation on the Neuronal Mechanisms of Cognitive Control in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Transcranial Direct Current Stimulation
tDCS
Cognitive Control
fMRI
Dorsolateral Prefrontal Cortex
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Sham Stimulation followed by Direct Current Stimulation or Vice-Versa
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to better understand the neural correlates of cognitive control (CC) deficits in schizophrenia and determine how these mechanisms can be modulated by transcranial direct current stimulation (tDCS). CC is a critical neurocognitive process that is required for flexible, directed thought and action based on goals and intentions. Identifying and developing paradigms to improve CC is therefore a mental health priority. Current theories of CC postulate that recruitment of the dorsolateral prefrontal cortex (DLPFC) is essential for this process by maintaining high-level information that it can then use to orchestrate patterns of activation in other brain networks to support optimal performance. tDCS is a safe, noninvasive method of modulating regional brain excitability via brief (15-20 m) application of a weak (1-2 mA) current. The goal of the proposed experiments is to combine tDCS with functional magnetic resonance imaging (fMRI) to test the hypotheses that 1) acute tDCS over the DLPFC can improve performance during a CC task (the dot pattern expectancy (DPX) variant of the AX-Continuous Performance Task) in schizophrenia patients and healthy control subjects, and 2) acute tDCS over the DLPFC can increase recruitment of the DLPFC during the DPX. Effects of tDCS on brain functional connectivity (during CC as well as during the resting state) will also be examined, as well as effects on an episodic memory task. The current study will be the first to use functional magnetic resonance imaging (fMRI) to examine the effects of tDCS on the neuronal mechanisms of CC in schizophrenia, and has potentially important implications for therapeutic development for this treatment refractory yet disabling aspect of the illness.


Eligibility criteria: Inclusion Criteria

* Sufficient English literacy so as to be able to understand and complete cognitive tasks.
* The ability to give valid informed consent.
* Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (for patient group)
* Stable outpatient or partial hospital status (for patient group)

Exclusion Criteria

* Psychiatric medication changes in the prior month (for patient group)
* No psychiatric medication changes anticipated in the upcoming month (for patient group)
* Intelligence Quotient (IQ) \< 70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test.
* People under the age of 18
* Pregnant Women
* Prisoners
* Pacemakers
* Implanted brain stimulators
* Implanted defibrillator
* Metallic implants
* Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
* Dreadlocks or other hair styles hindering the placement of tDCS electrodes
* Cranial pathologies
* Head trauma
* Epilepsy
* Mental retardation
* Neurological disorders
* 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).
* Other than nicotine, no subjects reporting substance dependence in the past six months and no substance abuse in the past month

Primary outcomes:
measure: Dorsolateral Prefrontal Cortex Response
timeFrame: Assessment will begin immediately following stimulation and last for up to an hour.
measure: Behavioral Response
timeFrame: Assessment will begin immediately following stimulation and last for up to an hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Imaging Research Center, University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Cameron Carter, M.D.
role: STUDY_DIRECTOR
References: