Actively Recruiting
Deep Brain Stimulation for Severe Anorexia Nervosa
Led by Centre Hospitalier St Anne · Updated on 2024-07-10
12
Participants Needed
1
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Deep Brain Stimulation for Severe Anorexia Nervosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Anorexia nervosa according to DSM V criteria.
- Age 18 to 65 years.
- Chronic, treatment-resistant anorexia nervosa with illness lasting at least 7 years.
- Inability to maintain a BMI 17 kg/m8 for 2 months after hospitalization in a specialized eating disorder center, with failure of at least 2 hospitalizations.
- Inability to maintain a BMI 17 kg/m8 for more than 3 consecutive months during outpatient treatment by a specialized team in the previous year, with failure of at least 2 outpatient treatments.
- Impaired psychological, social, and occupational functioning with a Global Assessment of Functioning score 45.
- Anorexia nervosa is the primary disorder if there are psychiatric comorbidities, confirmed by two experts.
- Ability to comply with study requirements and complete protocol forms.
- Written informed consent provided.
- Drug-free or on stable medication for at least 6 weeks before study entry.
- If female and of childbearing age, use of effective contraception.
- Membership in a health insurance plan or beneficiary.
You will not qualify if you...
- 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 two experts.
- Severe neurological conditions or significant MRI abnormalities (excluding anorexia-related atrophy).
- Inability to understand risks and give informed consent.
- Albumin levels below 30 g/L.
- Medical contraindications to DBS implantation or MRI (e.g., pacemaker).
- Pregnant or breastfeeding women.
- Previous deep brain stimulation treatment.
- Trusted person or family objects to participation.
- Contraindications to general anesthesia.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Viviane AWASSI
Paris, France
Actively Recruiting
Research Team
M
Marc ZANELLO, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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