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Clinical Trials/NCT07197502
NCT07197502RecruitingNot Applicable

CLINICAL TRIAL: Treatment of Borderline Personality Disorder by Targeting Ventrolateral Prefrontal-amygdala Circuit With Network-based Neuronavigated Transcranial Magnetic Stimulation

University of California, Los Angeles2 sites in 1 country30 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Borderline Symptom List 23 (BSL-23)

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: Transcranial Magnetic Stimulation (TMS) (Device)

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.

Intervention: Transcranial Magnetic Stimulation (TMS) (Device)

Outcomes

Primary Outcomes

Borderline Symptom List 23 (BSL-23)

Time Frame: Baseline (Day 1) and Post treatment (Day 17)

Borderline Symptom List 23 (BSL-23)

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

Time Frame: Baseline (Day 1) and Post treatment (Day 17)

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

Difficulties in Emotion Regulation Scale (DERS)

Time Frame: Baseline (Day 1) and Post treatment (Day 17)

Difficulties in Emotion Regulation Scale (DERS)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrew F. Leuchter

Principal Investigator

University of California, Los Angeles

Study Sites (2)

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