Schizophrenia Clinical Trial
Official title:
High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study
The main purpose of this study is to determine whether intensive repetitive transcranial magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in schizophrenia patients and whether it has a positive influence on their cognitive functions, social functions, quality of life, alpha frequency and cortical silent period changes. Also, this study should provide data about safety and tolerability this I-rTMS treatment in schizophrenia patients.
Patients undergo 5x EEG from safety and research reasons during the study. Stimulation coil
location (left DLPFC) is determined by magnetic resonance imaging (1,5T, 3D- TFE, voxel size
1 x 1 x 1 mm, Intera MR scanner) and stereotactic neuronavigation (Brainsight Frameless).
Patients are evaluated by several psychiatric scales. Positive and negative symptom scale
(PANSS) is applied before the first stimulation, at the end of every stimulation day and two
weeks after the last stimulation (a total 6). Other psychiatric evaluations used are
Clinical global impression (CGI), Sheehan disability scale (SDS), Personal and social
performance scale (PSP) and Montgomery-Asberg Depression Scale (MADRS), Calgary depression
scale for schizophrenia (CDSS); (MADRS and CDSS are for the exclusion of depression). These
scales were used only before the start of the first stimulation, after its completion and
two weeks after the last test.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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