Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Personality Disorder, Borderline
- Sponsor
- University of Regensburg
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Hamilton depression rating scale (HDRS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Berthold Langguth, MD, Ph.D.
Clinical Professor
University of Regensburg
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hamilton depression rating scale (HDRS)
Time Frame: 4 weeks
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Secondary Outcomes
- Depression module of the Patient health questionnaire (PHQ-D)(4 weeks, 12 weeks)
- nicotine use(2 weeks, 4 weeks, 12 weeks)
- Major Depression Inventory (MDI)(2 weeks, 4 weeks, 12 weeks)
- Hamilton depression rating scale (HDRS)(2 weeks, 4 weeks, 12 weeks)
- Borderline Symptom List (BSL-23)(2 weeks, 4 weeks, 12 weeks)
- Clinical global impression (CGI)(2 weeks, 4 weeks, 12 weeks)
- Barratt impulsiveness Scale (BIS)(4 weeks, 12 weeks)
- Numeric rating scale of pain(2 weeks, 4 weeks)