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临床试验/NCT07197502
NCT07197502招募中不适用

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 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Borderline Symptom List 23 (BSL-23)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Transcranial Magnetic Stimulation (TMS) (Device)

结局指标

主要结局

Borderline Symptom List 23 (BSL-23)

时间窗: Baseline (Day 1) and Post treatment (Day 17)

Borderline Symptom List 23 (BSL-23)

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

时间窗: Baseline (Day 1) and Post treatment (Day 17)

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

Difficulties in Emotion Regulation Scale (DERS)

时间窗: Baseline (Day 1) and Post treatment (Day 17)

Difficulties in Emotion Regulation Scale (DERS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew F. Leuchter

Principal Investigator

University of California, Los Angeles

研究点 (2)

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