Could deep brain stimulation break the grip of severe anorexia?
NCT ID NCT05245643
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial investigates whether deep brain stimulation (DBS) — a surgical technique that uses implanted electrodes to regulate brain activity — can be a safe treatment for people with severe, long-lasting anorexia nervosa that has not responded to other therapies. The study will enroll 12 adults aged 18 to 65 who have had anorexia for at least 7 years and cannot maintain a healthy weight. The main goal is to check for serious side effects; researchers will also see if patients accept this approach and whether it helps with weight and other measures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- deep brain stimulation of the nucleus accumbens using the Abbott Infinity Deep Brain Stimulation System
- What this could lead to
- If it works, this could offer a new treatment option for people with severe, treatment-resistant anorexia nervosa, a condition with no approved therapies.
- What could go wrong
- This is a very small, early safety trial with only 12 participants. Brain surgery carries risks of infection, bleeding, and other serious complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
12 people
The number who actually took part.
- Started
-
Apr 2022
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anorexia nervosa are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Viviane AWASSI
Paris, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pudding snack reveal how the brain misreads the stomach?
- Could the gut microbiome hold clues to eating disorder recovery?
- Can a parent support group help teens with both autism and anorexia?
- Lab-Grown brain cells could unlock Anorexia's secrets
- Can science unlock the secrets of the naturally lean?
- Can a memory drug break the grip of Anorexia's rigid habits?