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The major target of the study is to confirm the safety and efficacy of our augmented protocol of theta-burst TMS in schizophrenia. Our aim is to confirm the beneficial effects of rTMS treatment on multiple aspects of the disorder such as (1) clinical aspect in terms of PANSS, (2) cognitive aspect such as emotion recognition (ER) and working memory (WM) / distractor filtering (DF) performance, and (3) neurobiology in terms of electrophysiology correlates of ER, WM and DF such as ERPs, event related theta synchronization, resting state theta power, and network connectivity. Response prediction to (theta-burst) TB-rTMS will be the exploratory part of the study.
Response prediction will be based on spectral slope, individual alpha peak, and frontal alpha asymmetry, calculated from baseline resting-state EEG in the closed-eye condition (the open-eye condition may also be used). Baseline resting-state fMRI will also be used to predict responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theta-burst rTMS | Experimental | Theta-burst repetitive transcranial magnetic stimulation |
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| Sham stimulation | Sham Comparator | Sham stimulation of the same location |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Theta-burst stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale, Negative subscore | The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. It is the gold standard in the treatment monitoring of schizophrenia.The scale has three subscales : positive, negatve and general symptom score. We use the negative subscore as primary outcome. Its minimum and maximum scores are 7 and 49 respectively. Higher values indicate worse outcome. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests | They will be used to assess working memory. Digits Recalled is the primary outcome measure ranging between 2 and 10. Lower values indicate worse outcome. | 4 weeks |
| Cognitive functioning/Executive functioning - Wisconsin Card Sorting test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy | Budapest | Budapest | 1083 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38632647 | Derived | Csukly G, Orban-Szigeti B, Suri K, Zsigmond R, Herman L, Simon V, Kabaji A, Bata B, Harsfalvi P, Vass E, Csibri E, Farkas K, Rethelyi J. Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial. Trials. 2024 Apr 17;25(1):269. doi: 10.1186/s13063-024-08106-9. |
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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 |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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The test will be used to measure cognitive flexibility/Executive functioning. Number of persevarative errors is the major outcome variable of the test, its minimum is 0, while it has no theroretical maximum value. Higher values indicate worse outcome. Punishment sensitivity (P) from the reinforcement learning model of WCST will also be used as outcome variable. Its minimum value is 0 and it has no theoretical maximum value. Lower values indicate worse outcome. |
| 4 weeks |
| Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test ' | The total score is the primary outcome, which ranges between 0 and 37 points. Lower values indicate worse outcome. | 4 weeks |
| Social cognition 2 - The 'Faux Pas' test. | Measures Theory of Mind (ToM), and the primary outcome measure is the total score, which ranges between 0 and 1. Lower values indicate worse outcome. | 4 weeks |
| Facial Emotion Recogniton - Karolinska Directed Emotional Face set | Facial expression recognition task. Subject have to identify emotional expressions from photographs of 8 male and 8 female subjects. The pictures are chosen from Karolinska Directed Emotional Face set. There are 3 photographs from each faces (happy, neutral, and sad). Hit rate is the primary outcome measure, which ranges from 0% to 100%, and lower values indicate worse outcome. A 64-channel high-density EEG is recorded during the task, and ERPs (e.g., n170) are calculated for each emotion condition and EEG channel. | 4 weeks |
| Safety in terms of adverse events | Safety in terms of the number of serious adverse events (SAE). A Serious Adverse Event is any untoward medical occurrence that:
| 4 weeks |