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The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized aiTBS active - sham | Experimental | counterbalanced crossover with sham neuronavigated stimulation |
|
| Conventional (F3) aiTBS active - sham | Active Comparator | counterbalanced crossover with sham neuronavigated stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuronavigated aiTBS | Device | Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC) |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale) | Administer Rating Scale | 6 weeks |
| heart rate and its variability in RR slope and RMSSD values | Potential marker of treatment response | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale) | Administer Rating Scale | 6 weeks |
| Beck Depression Inventory (BDI-2 scores in units of scale) | Self Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Goya-Maldonado, MD | University Medical Center Göttingen (UMG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen) | Göttingen | Germany |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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The investigators compare study outcomes using aiTBS in personalized stimulation targets vs conventional F3 stimulation targets in parallel arms, each arm controlled by its respective sham stimulation in a counterbalanced crossover design.
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| 6 weeks |
| DMN decoupling / other networks in rho and z values | Potential markers of treatment response | 4-6 weeks |
| epi / genetic markers of neuroplasticity in ng | Potential markers of treatment response | 5-6 weeks |