Schizophrenia Clinical Trial
Official title:
Evaluation of the Efficacy of Transcranial Direct Current Stimulation in the Treatment of Cognitive Symptomatology in the Early Stages of Psychosis: Study Protocol of a Double-blind Randomized Controlled Trial
Background: Cognitive deficits are a core symptom of schizophrenia even at the early stages
of psychosis. To date, there has been reliable evidence that cognitive deficits are
associated with outcomes in schizophrenia and early treatment could help to reduce the
prominent disabling cognitive symptomatology which most schizophrenia patients still
experience persistently. Outcomes in studies of repetitive transcranial magnetic stimulation
in schizophrenia patients suggest the possibility that application of transcranial
direct-current stimulation (tDCS) with inhibitory stimulation over the left temporo-parietal
cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect
positive and negative symptoms, respectively. Positive effects of tDCS have also been
reported on cognitive symptoms. The present study protocol hypothesis is that the development
and utilization of potentially effective neuroenhancement tools such as a non-invasive brain
stimulation technique like tDCS for the treatment and rehabilitation of cognitive impairment
in early stages of Schizophrenia may contribute to the elucidation of the nature of the
complex and dynamic processes in the brain during the early stages of the disease, and may
lead to a better outcome.
Objectives: The aim of the present study protocol is to evaluate the efficacy of tDCS in the
treatment of cognitive symptomatology in the early stages of psychosis.
Methods: Sixty patients in the early stages of psychosis will be randomly allocated to
receive 20 minutes of active 2-mA tDCS or sham stimulation once a day on 10 consecutive
weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the
cathode over the left temporo-parietal cortex. Neuropsychological and psychiatric assessments
will be performed at the time of consent (baseline), at 1 and 3 months following the end of
the intervention (maintenance effect).
The design of the present study protocol is a double-blind placebo controlled randomised
clinical trial.
After being randomly allocated, the experimental group will receive a 20 minutes of active
2-mA tDCS once a day on 10 consecutive weekdays. The control group will receive a sham
stimulation (placebo), which chosen parameters consists in after 40 seconds of real
stimulation (2 mA), only a small current pulse occurred every 550 msec (110 mA over 15 msec)
through the remainder of the 20-minute period.
Neuropsychological and psychiatric assessments will be performed at the time of consent
(baseline), and at 1 and 3 months following the end of the intervention (maintenance effect).
The primary outcome will be cognitive function and the second outcomes will be the positive
and negative symptoms. Outcome assessments will be performed by trial research staff. Primary
and second outcomes assessors (neuropsychologists and psychiatrists) and patients will be
blinded to randomized allocation after assignment to interventions.
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