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

Not Applicable

Recruiting

• Conditions: F60.31; F32; Depressive episode

• Registration Number: DRKS00020413
• Lead Sponsor: VR-Klinikum Düsseldorf, Kliniken der Heinrich-Heine-Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>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.