Schizophrenia Clinical Trial
Official title:
Improving Cognition in Schizophrenia Using Transcranial Direct Current Stimulation
This study will examine the benefits of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving neurocognitive and social cognitive functions in schizophrenia. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in healthy individuals and several clinical populations. In this pilot study, the investigators will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia. Each participant will arrive for three visits, with approximately one week between each visit. During the first visit, participants will be interviewed about their psychiatric symptoms, personal life experiences, and emotional well being by a specially-trained interviewer. On each of the three visits, participants will receive one of three stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current). Immediately following the stimulation, participants will be asked to complete measures of mental abilities, including tests presented on a computer screen and paper-and-pencil tests. During each visit, participants will also undergo a standard measure of brain activity (EEG) while listening to tones. The first visit will last approximately five hours, and the other two visits will last approximately four hours each. The project will take approximately two years to complete.
The investigators plan to recruit 40 individuals diagnosed with Schizophrenia. Participants
will range from 18-55 years old. We will select stable, medicated patients who have not been
hospitalized nor had any changes in their antipsychotic medications during the previous two
months. Participants will not be tested within 12 hours of taking medications that may affect
cognition (such as benzodiazepines and anticholinergics). All medications will be recorded.
The investigators expect most of the patients to be relatively chronic (mean illness
chronicity approximately 15 years, based on previous studies), although we will not select
for chronicity.
All participants will provide written informed consent after receiving a full explanation of
the procedures according to approvals by the Institutional Review Boards. They will arrive
for three visits. In the first visit, they will be consented, complete the diagnostic
interview, the rating scales, and will undergo one of three randomly assigned stimulation
conditions: 1) anodal tDCS, 2) cathodaltDCS, and 3) sham stimulation. They will also undergo
an electroencephalography (EEG) procedure, in order to more directly assess the effect of
tDCS on brain function. This visit will take approximately five hours to complete, and breaks
will be given as needed. Immediately following stimulation, participants will complete
neurocognitive, social cognitive, and EEG measures. There will be two 20-minute stimulation
sessions, with a break of one hour between the sessions. After each session, participants
will be asked to complete a portion of the basic cognitive, social cognitive, and EEG
measures, so that half of the measures will be completed after the first 20 minute
stimulation session and the other half will be completed after the second 20 minute
stimulation session. The order of administration of the neurocognitive, social cognitive, and
EEG measures will be randomized across participants within each group. During the second and
third visits, participants will undergo the remaining two stimulation conditions, one
randomly assigned condition each visit. These visits will take approximately four hours to
complete, and each visit will be separated by at least one week from the previous visit.
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