Treatment of Borderline Personality Disorder With rTMS (ClinicalBPD)

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Borderline Personality; Borderline Personality Disorder; BPD - Borderline Personality Disorder

Treatments: Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07197502

23-001340

Details and patient eligibility

About

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.

Full description

Borderline personality disorder (BPD) is a serious and pervasive psychiatric condition with a prevalence of 1-5% among the general population. Two core symptoms of BPD are dysfunctional emotion regulation and marked impulsivity resulting in severe psychological suffering in terms of depression and anxiety as well as maladaptive impulsive acts, particularly self-harming behaviors including suicide. Recent advances in affective neuroscience of BPD combined with progress in brain imaging and neuromodulation technologies have opened new avenues for the development of innovative, brain-based, and more effective treatments for BPD.

This project aims to test the efficacy of a novel circuit-based treatment for BPD. The investigators will utilize multimodal neuroimaging Magnetic Resonance Imaging (MRI), and electroencephalogram (EEG) and BPD-, depression- and anxiety-related clinical scales to objectively measure the impact of Transcranial Magnetic Stimulation (TMS) treatment on overall BPD as well as depressive and anxiety symptom severity. Furthermore, a battery of cognitive tasks will be used to specifically measure the effect of TMS on the neurobehavioral indicators of impulsivity and emotion regulation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Active

Experimental group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Sham- followed by Active treatment

Experimental group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)