OFC rTMS in Emotionally Unstable and Depressed Patients

University of Regensburg15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Personality Disorder, Borderline Personality Disorder; Unstable Depression

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores

Time frame: 4 weeks

Secondary Outcomes

Major Depression Inventory (MDI)

measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores

Time frame: 2 weeks, 4 weeks, 12 weeks

Clinical global impression (CGI)

measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms

Time frame: 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

Time frame: 4 weeks, 12 weeks

Barratt impulsiveness Scale (BIS)

measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores

Time frame: 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

Time frame: 2 weeks, 4 weeks

nicotine use

number of smoked cigarettes per day (the higher the value the higher the use)

Time frame: 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

Time frame: 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

Time frame: 2 weeks, 4 weeks, 12 weeks

OFC rTMS in Emotionally Unstable and Depressed Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes