Deep Brain Stimulation for Severe Anorexia Nervosa

NCT05245643 | Recruiting DMC

• 1 other identifier: D21-P014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

Disease Resistance; Deep brain stimulation; Neuropsychological Tests; Patient Acceptance of Health Care

Outcome Measures

Primary Outcomes (1)

• Rate of serious adverse event

  A serious adverse event is defined as any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalization or causes prolongation of existing hospitalization Results in persistent or significant disability/incapacity May have caused a congenital anomaly/birth defect Requires intervention to prevent permanent impairment or damage. In this study, SAE are permanently monitored. After each patient inclusion, SAE rate is calculated: it has to remain inferior to 25% of the included population.

  Through study completion (2 years)

Secondary Outcomes (19)

• Measure of protocol acceptability

  At the end of the inclusions (2 years after study start)

• BMI Monitoring

  Through study completion (each month), during 2 years

• Pupillometry variation

  Through study completion: during the preoperative (2 weeks before the surgery), early postoperative (1 month after the surgery), late postoperative (4 months after the surgery) and end of study (11 months after the surgery) neurocognitive assessments

• Scores of Eating Disorder Inventory-2

  Through study completion: during the preoperative (2 weeks before the surgery), early postoperative (1 month after the surgery), late postoperative (4 months after the surgery) and end of study (11 months after the surgery) neurocognitive assessments

• Scores of Delayed Discounting Task

  Through study completion: during the preoperative (2 weeks before the surgery), early postoperative (1 month after the surgery), late postoperative (4 months after the surgery) and end of study (11 months after the surgery) neurocognitive assessments

Study Arms (1)

Patients with severe and resistant Anorexia Nervosa

OTHER

12 consecutive patients fulfilling the inclusion criteria and consenting to participate in the research, recruted in the three inclusion centers.

Device: Abbott Infinity Deep Brain Stimulation System

Interventions

Abbott Infinity Deep Brain Stimulation System DEVICE

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.

Also known as: DBS of both nucleus accumbens

Patients with severe and resistant Anorexia Nervosa

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Anorexia nervosa according to DSM V criteria.
• Age 18 to 65 years.
• 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.
• Impaired psychological, social and occupational functioning defined by a score ≤ 45 on the Global Assessment of Functioning Scale.
• 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.
• The patient is able to comply with the operational and administrative requirements of the study and is able to complete the protocol forms.
• Patient provides written informed consent.
• Patient is drug-free or on a medication that has been stable for at least 6 weeks at the time of study entry.
• If female subject and of childbearing age: use of an effective method of contraception.
• Membership in a health insurance plan or beneficiary.

You may not qualify if:

• Presence of an Axis I disorder that is primary to anorexia nervosa.
• Presence of a personality disorder that could compromise compliance with post-surgical follow-up assessed by 2 independent experts
• Presence of severe neurological pathology or significant MRI abnormalities (excluding anorexia-related atrophy).
• Cognitive and intellectual ability to understand the risks and constraints of the technique or to give informed consent.
• Albumin levels \<30g/L.
• Presence of medical contraindications to undergo implantation of a DBS system or to realize an MRI (pacemaker).
• Pregnant or breastfeeding woman.
• Previous DBS.
• Trusted person and/or family object to patient's participation.
• Contraindication to general anesthesia.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Viviane AWASSI

Paris, France

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Disease Resistance; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Marc ZANELLO, MD, PhD

CONTACT

+33 1 45 65 73 45; m.zanello@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicenter study: interventional cohort for surgical treatment (deep brain stimulation) in severe and resistant Anorexia Nervosa

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: February 18, 2022
• Study Start: April 14, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)