Treatment of Borderline Personality Disorder With rTMS

NCT07197502 | Recruiting FDA Device

• 1 other identifier: 23-001340
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This project studies the effectiveness of brain stimulation on borderline personality disorder (BPD) symptoms. This study is blinded, randomized and will enroll up to 30 participants. Participant will be consented for the study remotely via a secure internet platform called Zoom. Participants will undergo up to 2 MRI scans, 2 brain wave recording sessions and up to 30 brain stimulation treatments, and complete symptom assessments and cognitive behavioral tasks on a computer. Participation requires minimum of 17 in person visits over the course of 2.5 months. Participants are randomly assigned active or sham brain stimulation. Participants who received sham brain stimulation have the option to receive additional 15 active brain stimulation session.

Conditions

Borderline Personality Disorder; Borderline Personality; BPD - Borderline Personality Disorder

Keywords

BPD; rTMS; TMS; Borderline Personality Disorder

Outcome Measures

Primary Outcomes (3)

• Borderline Symptom List 23 (BSL-23)

  Borderline Symptom List 23 (BSL-23)

  Baseline (Day 1) and Post treatment (Day 17)

• Clinical Global Impression for Borderline Personality Disorder (CGI-BPD)

  Clinical Global Impression for Borderline Personality Disorder (CGI-BPD)

  Baseline (Day 1) and Post treatment (Day 17)

• Difficulties in Emotion Regulation Scale (DERS)

  Difficulties in Emotion Regulation Scale (DERS)

  Baseline (Day 1) and Post treatment (Day 17)

Study Arms (2)

Active

EXPERIMENTAL

Subjects in this group will receive active TMS treatment at vlPFC delivered by a magnet called A/P (active/placebo) coil. The A/P coil supports double-blinding of treatment. The coil has two sides, one of which is shielded so that no energy is imparted to the brain when the shielded side is applied to the subject's head. Small skin electrodes are applied to the scalp under the coil that impart a small microcurrent to the scalp simulating the sensation of active treatment. The operator receives a code from the device instructing them which side of the coil to use for each subject, ensuring complete treatment blinding.

Device: Transcranial Magnetic Stimulation (TMS)

Sham- followed by Active treatment

EXPERIMENTAL

Patients will be randomized to receive active or sham at vlPFC. Subjects assigned to the sham-controlled condition will be offered the opportunity to cross-over to open - label TMS treatment at the conclusion of the double-blind phase. This phase will serve as an incentive to recruitment because it ensures that all subjects (even those initially receiving sham stimulation) will eventually be eligible to receive active treatment. Rating scale scores will be obtained in the open-label extension just as scheduled in the controlled phase to gather additional information on efficacy of the active intervention.

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. Using pulsed magnetic fields, transcranial magnetic stimulation therapy stimulates the part of the brain thought to be involved with mood regulation. These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil.As these magnetic fields move into the brain, they produce very small electrical currents. These electrical currents activate cells within the brain, causing them to rewire, a process called neuroplasticity.

Active; Sham- followed by Active treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Age of 18-65 * DSM-5 Diagnosis of BPD based upon a psychiatric evaluation and ZAN-BPD * Fluent English speaker * Signed informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Semel Institute for Neuroscience and Human Behavior at UCLA

Los Angeles, California, 90024, United States

RECRUITING

Semel Institute/ UCLA TMS

Los Angeles, California, 90024, United States

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Elizabeth Pinkerton

CONTACT

310-794-0331; EPinkerton@mednet.ucla.edu

Research Coordinator

CONTACT

TMSResearch@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 29, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-09

Locations

US (2)