OFC rTMS in Emotionally Unstable and Depressed Patients
ORIENT
Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedDecember 9, 2022
December 1, 2022
2.4 years
February 5, 2020
December 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton depression rating scale (HDRS)
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
4 weeks
Secondary Outcomes (8)
Major Depression Inventory (MDI)
2 weeks, 4 weeks, 12 weeks
Clinical global impression (CGI)
2 weeks, 4 weeks, 12 weeks
Depression module of the Patient health questionnaire (PHQ-D)
4 weeks, 12 weeks
Barratt impulsiveness Scale (BIS)
4 weeks, 12 weeks
Numeric rating scale of pain
2 weeks, 4 weeks
- +3 more secondary outcomes
Study Arms (1)
OFC rTMS
EXPERIMENTALrepetitive transcranial magnetic stimulation
Interventions
repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Regensburg
Regensburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 6, 2020
Study Start
February 14, 2020
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
December 9, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share