OFC rTMS in Emotionally Unstable and Depressed Patients (ORIENT)

University of Regensburg (UR)

Status

Completed

Conditions

Personality Disorder; Unstable

Depression

Personality Disorder, Borderline

Treatments

Device: OFC rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT04259554

19-1615-101

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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