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The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS-1800 | Experimental | The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex. |
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| iTBS-1200 | Experimental | The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS-1800 | Device | Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG & More stimulator. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 17-item Hamilton Depression Rating Scale | 17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression) | Baseline, Week 1, Week 2, Week 4 |
| Change in Montgomery-Asberg Depression Rating Scale | Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression) | Baseline, Week 1, Week 2, Week 4 |
| Change in Beck Anxiety Inventory | Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey) | Baseline, Week 1, Week 2, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate after 2-week treatment at the end of iTBS (HDRD-17 ) | Improvement > 50 % of HDRD-17 | Baseline, Week 1, Week 2, Week 4 |
| Response rate after 2-week treatment at the end of iTBS (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
Have a concomitant major, unstable medical or neurologic illness :
Intracranial implant and other ferromagnetic materials close to the head.
History of Seizures.
Cardiac pacemaker.
Pregnancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChangGungMH | Kaohsiung City | 833 | Taiwan |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
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|
| iTBS-1200 | Device | Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG & More stimulator. |
|
Improvement > 50 % of MADRS
| Baseline, Week 1, Week 2, Week 4 |
| Changes in Clinical Global Index Severity | Clinical Global Index | Baseline, Week 1, Week 2, Week 4 |
| Changes in Heart Rate Variability (HRV) band | Heart rate variability measured by Wegene 8Z11 | Baseline, Week 1, Day 3, Week 2, Week 4 |
| Changes in EEG band | Changes in EEG band before and after brain stimulation. Subject EEG activity including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands. | Baseline, Week 1, Day 3, Week 2, Week 4 |
| Change in BDNF | Changes in BDNF values | Baseline, Week 2 |
| Change in TSH | Change in TSH values | Baseline, Week 2 |
| Change in T3 | Change in T3 | Baseline, Week 2 |
| Change in T4 | Change in T4 | Baseline, Week 2 |
| Change in cortisol | Change in cortisol | Baseline, Week 2 |