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OFC rTMS in Emotionally Unstable and Depressed Patients

NCT ID: NCT04259554

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2022-10-01

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.

Detailed Description

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Conditions

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Personality Disorder, Borderline Personality Disorder; Unstable Depression

Keywords

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rTMS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OFC rTMS

repetitive transcranial magnetic stimulation

Group Type EXPERIMENTAL

OFC rTMS

Intervention Type DEVICE

repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)

Interventions

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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)

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Berthold Langguth, MD, Ph.D.

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Regensburg

Regensburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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19-1615-101

Identifier Type: -

Identifier Source: org_study_id