Anorexia NervosaSTIMARSNCT05245643
Deep Brain Stimulation for Severe Anorexia Nervosa
A study testing Abbott Infinity Deep Brain Stimulation System in people with Anorexia Nervosa, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Abbott Infinity Deep Brain Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2022to 10 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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).
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- Pregnant or breastfeeding woman.
- Previous DBS.
- Trusted person and/or family object to patient's participation.
- Contraindication to general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STIMulation cérébrale Profonde Chez Des Patients Souffrant d'Anorexie Mentale Résistante et Sévère
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.
Read the detailed description
Main objective:
To selectively target for neuromodulation the key structures known to be involved in the motivational aspect of food intake, i.e. the nucleus accumbens, while evaluating safety and tolerance in the specific setting of AN patients (monitoring of serious adverse events [SAE])
Secondary objectives:
- Evaluation of patient's acceptance,
- Effect of DBS on weight stabilization (maintenance of patients' BMI above 14kg/m2),
- Effect of DBS on pupillometry in patients with severe and resistant AN,
- Effect of DBS on intermediate clinical variables such as loss of cognitive flexibility, overestimation of delayed rewards, and central coherence defect,
- Effect of DBS on psychiatric comorbidities of patients suffering from severe and resistant AN.
Prospective multicenter study: interventional cohort
Practical conduct:
- If all the inclusion criteria are met, proposal to participate in the study allowing a time window of 2 weeks of reflection before giving consent, B. Joint neurosurgeon/psychiatrist information consultation with delivery of a consent form, C. Preoperative assessment carried out after a delay of at least 2 weeks (anaesthesia consultation, brain MRI and neurocognitive assessment), D. Admisison in neurosurgery for one week to perform the DBS procedure. Post-operative CT Scan. The stimulation is turned on for all patients upon discharge from the hospital , E. Joint follow-up visit with the referring physician (once a month) and the neurosurgeon (once every 2 months) for 12 months F. Two neurocognitive assessments during follow-up visit : one early and one late postoperative (respectively at 5 and 11 months)
Inclusion period: 24 months Duration of preoperative assessment and reflection phase: 3 months Duration of participation (treatment + follow-up): 12 months Total duration: 40 months
Statistical analyses:
Descriptive results are presented as means ± standard deviations for continuous data and as percentages for categorical data.
The unpaired and paired t-test because of repeated measures in the same subjects, the Fisher's exact test will be use. A p<0.05 will be considered as statistically significant. A binomial sequence test is performed after each patient inclusion to check that the rate of SAE remains inferior to 25%.
- Conditions
- Anorexia Nervosa
- Being tested
- Abbott Infinity Deep Brain Stimulation System
- Keywords
- Disease Resistance, Deep brain stimulation, Neuropsychological Tests, Patient Acceptance of Health Care
- Medical subject headings
- Anorexia Nervosa, Disease Resistance, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Infinity Deep Brain Stimulation SystemDevice
Also called DBS of both nucleus accumbens
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Abbott Infinity Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (2 years)
Secondary outcomes (19)
Measure of protocol acceptability
Number of patients meeting inclusion criteria and accepting treatment / Number of patients meeting inclusion criteria and offered treatment
Measured: At the end of the inclusions (2 years after study start)
BMI Monitoring
Variation of BMI.
Measured: Through study completion (each month), during 2 years
Pupillometry variation
Pupillometry according to GHU PARIS Sainte Anne Clinique des Maladies Mentales et de l'Encéphale protocol.
Measured: 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
The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears.
Measured: 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
measure of temporal discounting, the tendency for people to prefer smaller, immediate monetary rewards over larger, delayed rewards
Measured: 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 The Brixton Spatial Anticipation Test
Measures the ability to detect rules in sequences of stimuli.
Measured: 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 the Trail Making Test
assess executive function
Measured: 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 the slips-of-action task
measure habit tendencies, the likelihood of making erroneous responses for devalued outcome
Measured: 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 the Wisconsin Card Sorting Test
measure the ability to display flexibility in the face of changing schedules of reinforcement
Measured: 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 the Montreal Cognitive Assessment
screening assessment for detecting cognitive impairment
Measured: 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 the Dubois' five words testing
Assess the verbal episodic memory
Measured: 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 the Rey-Osterrieth Complex Figure Test (ROCFT)
measure of constructional praxis and visual recall
Measured: 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 the Hospital Anxiety and Depression scale
detect states of depression and anxiety
Measured: 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 the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Rate the severity of obsessive-compulsive disorder symptoms
Measured: 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 the Scale for Suicide Ideation
Measures the current intensity of patients' specific attitudes, behaviors, and plans to commit suicide on the day of the interview.
Measured: 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 the Short Form (36) Health Survey
measure of health status
Measured: 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 the Global Assessment of Functioning
Rate subjectively the social, occupational, and psychological functioning of an individual
Measured: 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 the Zarit Burden Interview
Assess caregiving burden in clinical and research settings
Measured: 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
The Taylor Complex Figure Test (TCFT)
measure of constructional praxis and visual recall
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start14 Apr 2022
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multicenter study: interventional cohort for surgical treatment (deep brain stimulation) in severe and resistant Anorexia Nervosa
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245643
- Sponsor's protocol ID
- D21-P014
- Acronym
- STIMARS
- Status last verified
- Jul 2026
- First submitted
- 26 May 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STIMulation cérébrale Profonde Chez Des Patients Souffrant d'Anorexie Mentale Résistante et Sévère
- ClinicalTrials.gov ID
- NCT05245643
- Acronym / sponsor ID
- STIMARS / D21-P014
- Conditions
- Anorexia Nervosa
- Keywords
- Disease Resistance, Deep brain stimulation, Neuropsychological Tests, Patient Acceptance of Health Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main objective:
To selectively target for neuromodulation the key structures known to be involved in the motivational aspect of food intake, i.e. the nucleus accumbens, while evaluating safety and tolerance in the specific setting of AN patients (monitoring of serious adverse events [SAE])
Secondary objectives:
- Evaluation of patient's acceptance,
- Effect of DBS on weight stabilization (maintenance of patients' BMI above 14kg/m2),
- Effect of DBS on pupillometry in patients with severe and resistant AN,
- Effect of DBS on intermediate clinical variables such as loss of cognitive flexibility, overestimation of delayed rewards, and central coherence defect,
- Effect of DBS on psychiatric comorbidities of patients suffering from severe and resistant AN.
Prospective multicenter study: interventional cohort
Practical conduct:
- If all the inclusion criteria are met, proposal to participate in the study allowing a time window of 2 weeks of reflection before giving consent, B. Joint neurosurgeon/psychiatrist information consultation with delivery of a consent form, C. Preoperative assessment carried out after a delay of at least 2 weeks (anaesthesia consultation, brain MRI and neurocognitive assessment), D. Admisison in neurosurgery for one week to perform the DBS procedure. Post-operative CT Scan. The stimulation is turned on for all patients upon discharge from the hospital , E. Joint follow-up visit with the referring physician (once a month) and the neurosurgeon (once every 2 months) for 12 months F. Two neurocognitive assessments during follow-up visit : one early and one late postoperative (respectively at 5 and 11 months)
Inclusion period: 24 months Duration of preoperative assessment and reflection phase: 3 months Duration of participation (treatment + follow-up): 12 months Total duration: 40 months
Statistical analyses:
Descriptive results are presented as means ± standard deviations for continuous data and as percentages for categorical data.
The unpaired and paired t-test because of repeated measures in the same subjects, the Fisher's exact test will be use. A p<0.05 will be considered as statistically significant. A binomial sequence test is performed after each patient inclusion to check that the rate of SAE remains inferior to 25%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multicenter study: interventional cohort for surgical treatment (deep brain stimulation) in severe and resistant Anorexia Nervosa
| Arm | Type | Receives |
|---|---|---|
| Patients with severe and resistant Anorexia Nervosa | Other | Device: Abbott Infinity Deep Brain Stimulation System12 consecutive patients fulfilling the inclusion criteria and consenting to participate in the research, recruted in the three inclusion centers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of Anorexia nervosa according to DSM V criteria.
- Age 18 to 65 years.
- Chronic, treatment-resistant anorexia nervosa, defined as:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott Infinity Deep Brain Stimulation SystemAlso: DBS of both nucleus accumbensDBS is robot-assisted, with 3D intraoperative imaging control, under general anesthesia. Target is defined thanks to preoperative dedicated MRI with 2 independent experts' assessment. | Device | Patients with severe and resistant Anorexia Nervosa |
Primary outcome
Rate of serious adverse event
Time frame: Through study completion (2 years)
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.
19 secondary outcomes
Measure of protocol acceptability
Time frame: At the end of the inclusions (2 years after study start)
BMI Monitoring
Time frame: Through study completion (each month), during 2 years
Pupillometry variation
Time frame: 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
Time frame: 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
Time frame: 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 The Brixton Spatial Anticipation Test
Time frame: 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 the Trail Making Test
Time frame: 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 the slips-of-action task
Time frame: 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 the Wisconsin Card Sorting Test
Time frame: 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 the Montreal Cognitive Assessment
Time frame: 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 the Dubois' five words testing
Time frame: 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 the Rey-Osterrieth Complex Figure Test (ROCFT)
Time frame: 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 the Hospital Anxiety and Depression scale
Time frame: 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 the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 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 the Scale for Suicide Ideation
Time frame: 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 the Short Form (36) Health Survey
Time frame: 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 the Global Assessment of Functioning
Time frame: 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 the Zarit Burden Interview
Time frame: 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
The Taylor Complex Figure Test (TCFT)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott Infinity Deep Brain Stimulation System in people with Anorexia Nervosa, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of serious adverse event (time frame: Through study completion (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.