Depression, Personality Disorder, Borderline, Personality Disorder; Unstable
Conditions
Keywords
rTMS
Brief summary
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.
Interventions
DEVICEOFC rTMS
repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)
Sponsors
University of Regensburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ICD-10: F60.30 or F60.31 * depressive symptoms and HAMD-21 score of at least 7 * sex: female and male * residence in Germany and German speaking * written informed consent
Exclusion criteria
* meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump) * neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma) * participation in another study parallel to the Trial * other mental or somatic illness which is not compatible with participation according to the principal investigator * pregnancy or breastfeeding period * psychiatric confinement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton depression rating scale (HDRS) | 4 weeks | measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Depression Inventory (MDI) | 2 weeks, 4 weeks, 12 weeks | measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores |
| Clinical global impression (CGI) | 2 weeks, 4 weeks, 12 weeks | measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms |
| Depression module of the Patient health questionnaire (PHQ-D) | 4 weeks, 12 weeks | measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores |
| nicotine use | 2 weeks, 4 weeks, 12 weeks | number of smoked cigarettes per day (the higher the value the higher the use) |
| Numeric rating scale of pain | 2 weeks, 4 weeks | Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10 |
| Hamilton depression rating scale (HDRS) | 2 weeks, 4 weeks, 12 weeks | measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores |
| Borderline Symptom List (BSL-23) | 2 weeks, 4 weeks, 12 weeks | measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores |
| Barratt impulsiveness Scale (BIS) | 4 weeks, 12 weeks | measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores |
Countries
Germany
Outcome results
None listed