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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04259554
Other study ID # 19-1615-101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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