rTMS-enhanced Psychotherapy for Borderline Personality Disorder

NCT06259851 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-29

No results posted yet for this study

Summary

This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.

Conditions

  • Borderline Personality Disorder

Interventions

BEHAVIORAL

Dialectical behavioral therapy program

Dialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skills group 3 hours per week, phone coaching, and therapist consultation team 1,5 hour per week). The program takes 24 weeks in total comprising two 12-week runs of skills training. The program will be precluded with 4 individual sessions of pretreatment before the start of the main program part.

DEVICE

Prefrontal rTMS treatment

rTMS will be performed by DuoMag XT with 70BF cool coil. Patients will undergo 15 daily stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds. Gradual titration of the individual resting motor threshold (RMT) will apply, meaning probands will undergo first session with 90% RMT intensity, second session with 100% RMT intensity, third session with 110% RMT intensity. All the following sessions will use the final 120% RMT intensity. In case a session is left out because of any reason, the total duration of treatment will be prolonged by one day, so that the total number of sessions underwent is the same in all patients. Patients will receive 2000 pulses during one session (total 30000 pulses during the whole procedure) with 10 Hz frequency.

DEVICE

Sham rTMS sessions

Sham TMS will be performed by sham coil that looks identical to DuoMag XT in the active group. Patients will undergo 15 daily sham stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds.

Sponsors & Collaborators

  • Brno University Hospital

    collaborator OTHER
  • Masaryk University

    collaborator OTHER
  • Masarykova Univerzita

    lead OTHER

Principal Investigators

  • Libor Ustohal, prof, Ph.D. · University Hospital Brno

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259851 on ClinicalTrials.gov