Could deep brain stimulation break the grip of severe anorexia?

NCT ID NCT05245643

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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Conditions

The condition(s) this trial relates to.

anorexia nervosa Disease Resistance Patient Acceptance of Health Care

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

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