OFC rTMS in Emotionally Unstable and Depressed Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Personality Disorder, Borderline, Personality Disorder; Unstable, Depression

Intervention / Treatment
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* Device: OFC rTMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFC rTMS<br>repetitive transcranial magnetic stimulation | Device: OFC rTMS<br>* repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS