Nucleus accumbens deep brain stimulation in adult patients suffering from severe and enduring anorexia nervosa (STIMARS): protocol for a pilot study.

IF 3.2 3区 医学 Q2 PSYCHIATRY
Frontiers in Psychiatry Pub Date : 2025-03-20 eCollection Date: 2025-01-01 DOI:10.3389/fpsyt.2025.1554346
Philibert Duriez, Giorgia Antonia Simboli, Philippe Domenech, Anne Buot, Casey Halpern, Marie Fadigas, Yann Mongin, Aurore Guy-Rubin, Romain Carron, Catherine Oppenheim, Philip Gorwood, Johan Pallud, Marc Zanello
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Abstract

Background: Affecting adolescent and young adults, anorexia nervosa (AN) has the highest death rate of all mental disorders. Effective treatment options are lacking and a significant proportion of patients develop severe and chronic forms of the disease with long-lasting functional impairment. Neurobiology of AN implicates the nucleus accumbens as a core structure of the ventral striatum highly connected to the prefrontal cortex, the insula and the limbic system. Several studies reported promising results of deep brain stimulation for treatment-resistant AN. The aim of this study was to investigate the safety and efficacy of bilateral nucleus accumbens deep brain stimulation in severe and enduring AN.

Methods and analysis: This is a prospective, multicentre, single-arm, open-label, non-randomized pilot trial of bilateral nucleus accumbens deep brain stimulation for severe and enduring AN. Patients will be followed up for 24 months after deep brain stimulation. The main objective of this study is to measure the safety and feasibility of nucleus accumbens deep brain stimulation in this population. The recruitment rate will be collected prospectively. Potential deep brain stimulation efficacy will be monitored by changes in: 1) health-related quality of life; 2) weight; 3) eating disorder symptomatology; 4) neuropsychological changes of cognitive flexibility, habits formation, emotional processing and central coherence; 5) psychiatric comorbidities (anxiety, depression, obsession). Local field potential recordings during an exposure task will be proposed to the patients. Additionally, caregiver quality of life will be assessed.

Discussion: We present the design and rationale for a pilot study investigating the safety of nucleus accumbens deep brain stimulation for treatment resistant anorexia nervosa. This trial will provide an estimated effect size of nucleus accumbens deep brain stimulation for treatment-resistant anorexia nervosa to support future larger-scale clinical trials.

成人严重和持久神经性厌食症(STIMARS)患者的伏隔核深部脑刺激:一项试点研究方案。
背景:影响青少年和年轻人的神经性厌食症(AN)是所有精神障碍中死亡率最高的。缺乏有效的治疗方案,很大一部分患者发展为严重和慢性形式的疾病,并伴有长期的功能损害。AN的神经生物学暗示伏隔核是腹侧纹状体的核心结构,与前额皮质、脑岛和边缘系统高度相连。一些研究报告了深部脑刺激治疗难治性AN的有希望的结果。本研究旨在探讨双侧伏隔核深部脑刺激治疗重度和持续性AN的安全性和有效性。方法与分析:这是一项前瞻性、多中心、单臂、开放标签、非随机的双侧伏隔核深部脑刺激治疗严重和持续性AN的先导试验。脑深部电刺激后随访24个月。本研究的主要目的是衡量伏隔核深部脑刺激在这一人群中的安全性和可行性。招聘率将进行前瞻性统计。潜在的脑深部刺激效果将通过以下方面的变化来监测:1)健康相关的生活质量;2)重量;3)进食障碍症状学;4)认知灵活性、习惯形成、情绪加工和中枢连贯的神经心理变化;5)精神合并症(焦虑、抑郁、强迫症)。在暴露任务期间,将向患者提出局部场电位记录。此外,还将评估护理者的生活质量。讨论:我们提出了一项初步研究的设计和基本原理,该研究旨在调查伏隔核深部脑刺激治疗难治性厌食症神经的安全性。该试验将提供伏隔核深部脑刺激治疗难治性厌食症神经的估计效应大小,以支持未来更大规模的临床试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Frontiers in Psychiatry
Frontiers in Psychiatry Medicine-Psychiatry and Mental Health
CiteScore
6.20
自引率
8.50%
发文量
2813
审稿时长
14 weeks
期刊介绍: Frontiers in Psychiatry publishes rigorously peer-reviewed research across a wide spectrum of translational, basic and clinical research. Field Chief Editor Stefan Borgwardt at the University of Basel is supported by an outstanding Editorial Board of international researchers. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. The journal''s mission is to use translational approaches to improve therapeutic options for mental illness and consequently to improve patient treatment outcomes.
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