The Effect of Transcranial Direct Current Stimulation on Human Brains: A Neuroimaging Study
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this project is to examine brain function before, during, and after the
      administration of tDCS (Transcranial Direct Current Stimulation). The brain can perform its
      job well or poorly depending on many things. The investigators will be using computer tasks
      and paper and pencil questionnaires to measure the relationship between brain performance and
      the administration of tDCS. In addition, the study team will be using functional magnetic
      resonance imaging (fMRI) and related imaging techniques to see how your brain works and
      compare it with the results we collected from the paper and pencil questionnaires. This study
      will enroll both schizophrenia patients as well as healthy volunteers without any major
      psychiatric disorder or physical illness.
    

Detailed description: 
      This is a placebo condition controlled double blind randomized prospective study where the
      study team plan to acquire clinical, neurocognitive and imaging data in schizophrenia
      patients and healthy controls. Those who are eligible for the study will be consented, and
      will be randomized into either group A or B. The length of the study is four weeks. Subjects
      in both groups will undergo the same procedure, except that while subjects from group A
      unbeknownst to them will receive only a sham stimulation of tDCS (placebo condition), the
      subjects from group B will receive real tDCS stimulation. Real tDCS stimulation will involve
      ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the
      right suborbital region) on 5 weekdays of two consecutive weeks, while sham will contain 20
      minute sessions as well, but only the first minute will be with 2mA, then unbeknownst to the
      subject, the unblinded research assistant will turn off the stimulation. The subjects will be
      told that they can be given either a sham or real stimulation and will be asked at the end of
      the experiment to fill out a visual analog scale indicating their guess about being in the
      real or sham arm. Following the first two weeks of the study, there will be a follow up
      period of two weeks when no stimulation or sham will be administered. Subjects, raters,
      clinicians and most of the research persons will all be kept blind in regards to their
      placebo or stimulation status until the end of the study. Research persons analyzing
      neuroimgaing data will break blindness after subject leaves the study, to continuously
      monitor neuroimaging findings.
    

Intervention name(s): Transcranial direct current stimulation; Transcranial direct current stimulation - Sham
Intervention type(s): Device; Device
Intervention description(s): Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp.; Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp.
Other intervention name(s): tDCS; tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other