Deep Brain Stimulation for Severe Anorexia Nervosa

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

This study is testing if Deep Brain Stimulation can help people with severe anorexia who haven't responded to other treatments by focusing on parts of the brain that control food motivation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre Hospitalier St Anne (other)
• Locations: 1 site (Paris)
• Trial ID: NCT05245643 on ClinicalTrials.gov

What this trial studies

This study investigates the use of Deep Brain Stimulation (DBS) to treat patients with severe and treatment-resistant Anorexia Nervosa (AN). It aims to target specific brain structures involved in the motivation for food intake, while assessing the safety and tolerance of the procedure. The study will evaluate various outcomes, including weight stabilization, cognitive flexibility, and psychiatric comorbidities, through a multicenter interventional cohort approach. Participants will undergo a thorough preoperative assessment and will be monitored closely post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a chronic, treatment-resistant form of Anorexia Nervosa.

Not a fit: Patients who do not meet the criteria for chronic, treatment-resistant Anorexia Nervosa or those with a BMI above the specified threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from severe and resistant Anorexia Nervosa.

How similar studies have performed: While DBS has shown success in treating movement disorders, its application for Anorexia Nervosa is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Paris

• Viviane AWASSI — Paris, France (RECRUITING)

Study contacts

• Study coordinator: Marc ZANELLO, MD, PhD

Conditions: Anorexia Nervosa, Disease Resistance, Deep brain stimulation, Neuropsychological Tests, Patient Acceptance of Health Care