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RECRUITING

NCT05245643

Deep Brain Stimulation for Severe Anorexia Nervosa

Sponsor: Centre Hospitalier St Anne

View on ClinicalTrials.gov

Summary

The somatic complications as well as the suicidal risk make Anorexia Nervosa (AN) the psychiatric disease with the highest mortality rate: the standardized mortality ratio is higher than 4 and 1 in 5 patients with AN who dies has committed suicide. Approximately 20% of patients suffering from AN evolves into a chronic form without prolonged remission. These patients are at high risk of serious complications (somatic and psychiatric). The peak incidence of AN lies between 15 and 19 years: patients suffering from severe and resistant AN are therefore mostly young people. At present, there is no treatment for severe and resistant AN. New insights in AN pathophysiology revealed that AN patients develop a kind of "addiction" to thinness which contributes to weight loss despite negative consequences. In parallel, Deep Brain Simulation (DBS) is now widely performed for movements disorders with good results and low morbidity. DBS is also currently under investigations for other indications such as obsessional compulsive disorder or pharmacoresistant epilepsy. Some case series reported promising results of DBS for severe and resistant AN. The aim of this study is to investigate the safety of nucleus accumbens chronic stimulation for patients enduring severe and resistant AN. Secondary objective is to evaluate patient's acceptance of this new treatment.

Official title: STIMulation cérébrale Profonde Chez Des Patients Souffrant d'Anorexie Mentale Résistante et Sévère

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-04-14

Completion Date

2028-06-01

Last Updated

2024-07-10

Healthy Volunteers

Conditions

Anorexia Nervosa

Interventions

DEVICE

Abbott Infinity Deep Brain Stimulation System

DBS is robot-assisted, with 3D intraoperative imaging control, under general anesthesia. Target is defined thanks to preoperative dedicated MRI with 2 independent experts' assessment.

Inclusion Criteria: 1. Diagnosis of Anorexia nervosa according to DSM V criteria. 2. Age 18 to 65 years. 3. Chronic, treatment-resistant anorexia nervosa, defined as: * Anorexia nervosa evolving for at least 7 years. * Inability to maintain a BMI ≥ 17kg/m² for 2 months following hospitalization in a center specialized for the management of patients suffering from eating disorders according to the criteria of the French Federation of Anorexia and Bulimia nervosa and the Directorate General of Care Provision (Direction Générale de l'Offre de Soins - DGOS, in French). Failure of at least 2 hospitalizations in a specialized center during the history of the disease. * Inability to maintain a BMI ≥ 17kg/m² for more than 3 consecutive months during an outpatient treatment conducted by a team specialized for the care of patients suffering from eating disorders according to the criteria of the French Federation of Anorexia and Bulimia and the Directorate General of Care Provision (Direction Générale de l'Offre de Soins - DGOS, in French) in the year preceding the inclusion. Failure of at least 2 outpatient treatments conducted by a specialized team during the AN care. 4. Impaired psychological, social and occupational functioning defined by a score ≤ 45 on the Global Assessment of Functioning Scale. 5. Anorexia nervosa is judged to be the primary disorder if there are psychiatric comorbidities such as depression, anxiety disorder, obsessive-compulsive disorder, or personality disorder by at least two independent experts. 6. The patient is able to comply with the operational and administrative requirements of the study and is able to complete the protocol forms. 7. Patient provides written informed consent. 8. Patient is drug-free or on a medication that has been stable for at least 6 weeks at the time of study entry. 9. If female subject and of childbearing age: use of an effective method of contraception. 10. Membership in a health insurance plan or beneficiary. Exclusion Criteria: 1. Presence of an Axis I disorder that is primary to anorexia nervosa. 2. Presence of a personality disorder that could compromise compliance with post-surgical follow-up assessed by 2 independent experts 3. Presence of severe neurological pathology or significant MRI abnormalities (excluding anorexia-related atrophy). 4. Cognitive and intellectual ability to understand the risks and constraints of the technique or to give informed consent. 5. Albumin levels \<30g/L. 6. Presence of medical contraindications to undergo implantation of a DBS system or to realize an MRI (pacemaker). 7. Pregnant or breastfeeding woman. 8. Previous DBS. 9. Trusted person and/or family object to patient's participation. 10. Contraindication to general anesthesia.

Locations (1)

Viviane AWASSI

Paris, France