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STUDY PROTOCOL article
Front. Psychiatry
Sec. Neurostimulation
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1554346
Nucleus accumbens deep brain stimulation in adult patients suffering from severe and enduring anorexia nervosa (STIMARS): protocol for a pilot study
Provisionally accepted
Philibert DURIEZ 1 Giorgia Antonia SIMBOLI 1 Philippe DOMENECH 1 Anne BUOT 1 Casey HALPERN 2 Marie FADIGAS 1 Yann MONGIN 3 Aurore GUY-RUBIN 3 Romain CARRON 4 Catherine OPPENHEIM 1 Philip GORWOOD 1
Johan Pallud 1
Marc ZANELLO 1*- 1 Groupe Hospitalier Universitaire Paris, Paris, France
- 2 Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- 3 Clinique Villa Montsouris, Paris, France
- 4 Hôpital de la Timone, Marseille, Provence-Alpes-Côte d'Azur, France
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 incriminates implicates neural circuitry implicating 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, nonrandomized 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, caretaker 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 treatmentresistant anorexia nervosa to support future larger-scale clinical trials.Trial registration. The study was registered on clinicaltrials.gov on April 14, 2022 as "Deep Brain Stimulation for Severe Anorexia Nervosa (STIMARS)", with the identifier NCT05245643.
Keywords: feeding and eating disorders, Treatment-resistant, Electric Stimulation Therapy, ventral striatum, Safety, Intraoperative Complications, Postoperative Complications, habits
Received: 01 Jan 2025; Accepted: 04 Mar 2025.
Copyright: © 2025 DURIEZ, SIMBOLI, DOMENECH, BUOT, HALPERN, FADIGAS, MONGIN, GUY-RUBIN, CARRON, OPPENHEIM, GORWOOD, Pallud and ZANELLO. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Marc ZANELLO, Groupe Hospitalier Universitaire Paris, Paris, France
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