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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT02127879
Study type Interventional
Source Brno University Hospital
Contact Tomáลก Sverák, Mgr.
Phone +420737504353
Email 362515@mail.muni.cz
Status Recruiting
Phase N/A
Start date May 2014
Completion date October 2016

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