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| ID | Type | Description | Link |
|---|---|---|---|
| 61300 | Other Identifier | Department of Psychiatry, Faculty of Medicine, Masaryk University, Brno, Czech Republic |
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| Name | Class |
|---|---|
| Masaryk University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Active Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) |
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| Transcranial Magnetic Stimulation with sham coil | Sham Comparator | Sham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | 16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. pause is between every stimulation session for safety reasons.v |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS) | Baseline, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | Patients undergoing five times EEG during the study for safety reasons. The researcher assigns patients on their health and mental condition by Visual Analogous Scale every day before and after rTMS stimulation. | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in quality of life in the Quality of Life questionaire (SQUALA) at week 3 | At baseline, Week 3 | |
| Change from baseline in cognitive functions measured by Verbal learning test, Rey- Osterrieth complex figure, D2 test, Repeating numbers memory test, London tower test, Verbal fluency test at week 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomáš Svěrák, Mgr. | Contact | +420737504353 | 362515@mail.muni.cz |
| Name | Affiliation | Role |
|---|---|---|
| Tomáš Svěrák, Mgr. | Brno University Hospital | Principal Investigator |
| Radovan Přikryl, Prof. | Brno University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of psychiatry, University Hospital | Recruiting | Brno | Czech Republic | 62500 | Czechia |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Transcranial Magnetic Stimulation with sham coil | Device | 16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. Pause is between every stimulation session for safety reasons. |
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Verbal learning test testing memory (based on Rey Auditory Verbal Learning Test), Rey- Osterrieth complex figure testing testing sensomotoric and visuospatial skills, D2 test testing attention, Repeating numbers memory test testing working memory, London Tower test testing executive functions and Verbal fluency test testing verbal fluency and recalling of words
| Baseline, Week 3 |
| Change from baseline in social functions measured by Sheehan Disability Scale (SDS) and by Personal and Social Performance Scale (PSP) at week 3 | Baseline, Week 3 |
| Change from baseline in global clinical improvement measured by Clinical Global Impression (CGI) at week 3 | Baseline, Week 3 |
| Change from baseline in alpha frequency measured by EEG at week 3 | Baseline, Week 3 |
| Change from baseline in cortical silent period measured by transcranial magnetic stimulation at week 3 | Baseline, Week 3 |