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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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Departement of psychiatry, University Hospital
Brno, Czech Republic, Czechia
Start Date
May 1, 2014
Primary Completion Date
October 1, 2016
Completion Date
October 1, 2016
Last Updated
May 5, 2014
40
ESTIMATED participants
Transcranial Magnetic Stimulation
DEVICE
Transcranial Magnetic Stimulation with sham coil
DEVICE
Lead Sponsor
Brno University Hospital
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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