Treatment of Borderline Personality Disorder With rTMS
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT07197502
- Status
- Recruiting
Conditions
- BPD - Borderline Personality Disorder
- Borderline Personality
- Borderline Personality Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Transcranial Magnetic Stimulation (TMS) — DEVICETranscranial 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.
Study Details
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.
Key Dates
- Start date
- Mar 1, 2025
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: ActiveSubjects 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.
- Experimental: Sham- followed by Active treatmentPatients 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.
Primary Outcome Measure
Borderline Symptom List 23 (BSL-23) [ Time Frame: Baseline (Day 1) and Post treatment (Day 17) ]
Central Contacts
- Elizabeth Pinkerton310-794-0331
- Research Coordinator
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Semel Institute for Neuroscience and Human Behavior at UCLA | Los Angeles | California | 90024 | Research Coordinator |
| Semel Institute/ UCLA TMS | Los Angeles | California | 90024 | UCLA TMS Research Coordinator Andrew Leuchter, MD (PRINCIPAL_INVESTIGATOR) Reza Tadayon-Nejad, MD, PhD (SUB_INVESTIGATOR) |
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