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The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TB-rTMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol | Device | Theta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptoms | The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Ã…sberg Depression Rating Scale. | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroimaging characteristics | A secondary outcome measure is neuroimaging characteristics including the alpha peaks measured by EEG, the nonoscillatory component (1/f) calculated from resting EEG, and connectivity parameters measured by fMRI. These markers will play a part in response prediction. | 120 days |
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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 | Pest County | 1083 | Hungary |
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| Patient profile |
The patient profile encompasses demographics and clinical characteristics, namely age, sex, level of education, history of other psychiatric conditions, comorbidities, and medications. Together with neuroimaging characteristics, these will be used for response prediction. |
| 120 days |
| Cognitive functioning/Spatial working Memory | The test will be used measure spatial working memory. Memory span is the major outcome variable of this test (the longest number of elements correctly retraced). Higher values indicate better outcomes. Its minimum value is 0 and it has no theoretical maximum value. | 120 days |
| Cognitive functioning/Executive function | The test will be used measure executive functioning. Number of mistakes is the major outcome variable of this test (mistakes arise when subjects fail to differentiate a distractor from the continuous task). Higher values indicate worse outcomes. Its minimum value is 0 and it has no theoretical maximum value. Time Frame: 120 days | 120 days |
| Cognitive functioning/reaction time | The test will be used measure executive functioning and reaction time. Average reaction time is the major outcome variable of this test. Higher values indicate worse outcomes. | 120 days |
| Clinical symptoms based on self-report questionnaires | Beck depression inventories are to be used to monitor clinical symptoms of depression | 120 days |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood 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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