Меню
Идёт набор NCT07197502

Treatment of Borderline Personality Disorder With rTMS

Без фазы С лечением Borderline Personality Disorder Borderline Personality BPD - Borderline Personality Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Magnetic Stimulation (TMS).
Кому может быть актуально
Состояния в реестре: Borderline Personality Disorder, Borderline Personality, BPD - Borderline Personality Disorder. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Transcranial Magnetic Stimulation (TMS)
    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 int

Первичные конечные точки

  • Borderline Symptom List 23 (BSL-23) [Срок оценки: Baseline (Day 1) and Post treatment (Day 17)]
  • Clinical Global Impression for Borderline Personality Disorder (CGI-BPD) [Срок оценки: Baseline (Day 1) and Post treatment (Day 17)]
  • Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: Baseline (Day 1) and Post treatment (Day 17)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Semel Institute for Neuroscience and Human Behavior at UCLA — Los Angeles
  • Semel Institute/ UCLA TMS — Los Angeles

Идентификаторы

NCT: NCT07197502 · 23-001340

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗