OFC rTMS in Emotionally Unstable and Depressed Patients (ORIENT)

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

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 Overview

• Status: Completed
• Conditions: Depression; Personality Disorder, Borderline; Personality Disorder; Unstable
• Intervention / Treatment: Device: OFC rTMS

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany
    • University of Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OFC rTMS; repetitive transcranial magnetic stimulation	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton depression rating scale (HDRS)	measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Barratt impulsiveness Scale (BIS)	measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores	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	2 weeks, 4 weeks
nicotine use	number of smoked cigarettes per day (the higher the value the higher the use)	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	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	2 weeks, 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Regensburg

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: rTMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Personality Disorders; Depression; Disease; Borderline Personality Disorder
• Other Study ID Numbers: 19-1615-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No