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Intermittent theta-burst stimulation (iTBS) as concomitant treatment for borderline personality disorder - a pilot study

Intermittent theta-burst stimulation (iTBS) as concomitant treatment for borderline personality disorder - a pilot study - DBTTMS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020413
Enrollment
60
Registered
2020-01-13
Start date
2021-01-22
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F60.31 F32

Interventions

Group 1: Patients with a primary diagnosis of borderline personality disorder, who are receiving an inpatient, dialectical behavioural therapy based psychiatric treatment will be treated with intermit

Sponsors

LVR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: - Borderline Personality Disorder (DSM V) assessed through a standardized clinical interview (SKID V PD) - sufficient knowledge of German - Age: 18-45 - No prior treatment with DBT - If medicated stable treatment with the medication for 2 weeks before commendement of the brain stimulation treatment. Medication should remain stable during the 4-weeks of brain stimulation. - Receiving inpatient or day-clinic, standardized, DBT-based treatment - Participants must be able to give consent to participate - Negative pregnancy test and being prepared to use contraception for the duration of brain stimulation treatment

Exclusion criteria

Exclusion criteria: - history of seizures or epilepsy - metallic implants of the skull - extensive tatoos on the head - significant brain tumors or brain malformations - cerebrovascular events - traumatic brain injury - neurodegenerative disorders - brain surgery - deep brain stimulation - Pacemaker - severe somatic disorders - other psychiatric comorbidities (measured by Mini-DIPS-OA) except Depression - acute suicidality (MADRS Score >4 for Item 10) - tinnitus - pregnancy - claustrophoby - treatment with antiepileptic drugs - taking benzodiazepines in doses exceeding 1mg Lorazepam per day - patients under legal guardianship who require their guardian's approval to provide consent - treatment with electroconvulsive therapy in the current episode - current or prior treatment with deep brain stimulation, vagus nerv stimulation or other intracranial implants

Design outcomes

Primary

MeasureTime frame
Improvements in borderline symptoms, reduction in impulsivity, changes in self-compassion measured using clinical questionnaires and cognitive tasks. These measures will be assessed before start of the stimulation, a number of measures weekly during the stimulation and all measures again at the end of the 4-weeks of stimulation.

Secondary

MeasureTime frame
Reduction in depressive symptoms, improvements in general functionality measured using clinical questionnaires that will be administered before starting the treatment, a number of measures weekly during the treatment, and all measures again at the end of the 4-week stimulation treatment. Additionally, an optional fMRI scan will be carried out before starting the stimulation to predict treatment response using machine-learning based analyses. Furthermore, blood samples will be taken before and after the 4 week stimulation treatment to measure changes in metanephrine and heart rate variability will also be assessed before and after the Treatment optionally.

Countries

Germany

Contacts

Public ContactMilenko Kujovic

LVR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität

milenko.kujovic@lvr.de+49(211)922-2735

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026