OFC rTMS in Emotionally Unstable and Depressed Patients

Not Applicable

Completed

• Conditions: Depression; Personality Disorder, Borderline; Personality Disorder; Unstable
• Interventions: Device: OFC rTMS

• Registration Number: NCT04259554
• Lead Sponsor: University of Regensburg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-02-14
• Primary Completion: 2022-07-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFC rTMS	OFC rTMS	repetitive transcranial magnetic stimulation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Depression module of the Patient health questionnaire (PHQ-D)	4 weeks, 12 weeks	measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores
nicotine use	2 weeks, 4 weeks, 12 weeks	number of smoked cigarettes per day (the higher the value the higher the use)
Major Depression Inventory (MDI)	2 weeks, 4 weeks, 12 weeks	measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores
Hamilton depression rating scale (HDRS)	2 weeks, 4 weeks, 12 weeks	measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Borderline Symptom List (BSL-23)	2 weeks, 4 weeks, 12 weeks	measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores
Clinical global impression (CGI)	2 weeks, 4 weeks, 12 weeks	measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms
Barratt impulsiveness Scale (BIS)	4 weeks, 12 weeks	measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores
Numeric rating scale of pain	2 weeks, 4 weeks	Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10

Trial Locations

Locations (1)

University of Regensburg; 🇩🇪 Regensburg, Germany