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Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFC rTMS | Experimental | repetitive transcranial magnetic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFC rTMS | Device | repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton depression rating scale (HDRS) | measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major Depression Inventory (MDI) | measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores | 2 weeks, 4 weeks, 12 weeks |
| Clinical global impression (CGI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg | Regensburg | Germany |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D010554 | Personality Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms
| 2 weeks, 4 weeks, 12 weeks |
| Depression module of the Patient health questionnaire (PHQ-D) | measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores | 4 weeks, 12 weeks |
| Barratt impulsiveness Scale (BIS) | measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores | 4 weeks, 12 weeks |
| Numeric rating scale of pain | Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10 | 2 weeks, 4 weeks |
| nicotine use | number of smoked cigarettes per day (the higher the value the higher the use) | 2 weeks, 4 weeks, 12 weeks |
| Hamilton depression rating scale (HDRS) | measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores | 2 weeks, 4 weeks, 12 weeks |
| Borderline Symptom List (BSL-23) | measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores | 2 weeks, 4 weeks, 12 weeks |