OFC rTMS in Emotionally Unstable and Depressed Patients

Depression Clinical Trial

— ORIENT  

Official title:

Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259554
• Other study ID #: 19-1615-101
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2022
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Depression
• Disease
• Personality Disorder, Borderline
• Personality Disorder; Unstable
• Personality Disorders

Intervention

Device:
• OFC rTMS
repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)

Locations

Country	Name	City	State
Germany	University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating scale (HDRS)	measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores	4 weeks
Secondary	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
Secondary	Clinical global impression (CGI)	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
Secondary	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
Secondary	Barratt impulsiveness Scale (BIS)	measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores	4 weeks, 12 weeks
Secondary	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
Secondary	nicotine use	number of smoked cigarettes per day (the higher the value the higher the use)	2 weeks, 4 weeks, 12 weeks
Secondary	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
Secondary	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