- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05245643
Deep Brain Stimulation for Severe Anorexia Nervosa (STIMARS)
STIMulation cérébrale Profonde Chez Des Patients Souffrant d'Anorexie Mentale Résistante et Sévère
Study Overview
Status
Conditions
Intervention / 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:
A. 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marc ZANELLO, MD, PhD
- Phone Number: +33 1 45 65 73 45
- Email: m.zanello@ghu-paris.fr
Study Locations
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Paris, France
- Recruiting
- Viviane AWASSI
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Contact:
- Marc ZANELLO, Dr
- Email: m.zanello@ghu-paris.fr
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Contact:
- Viviane AWASSI
- Email: info-recherche@ghu-paris.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- Pregnant or breastfeeding woman.
- Previous DBS.
- Trusted person and/or family object to patient's participation.
- Contraindication to general anesthesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Patients with severe and resistant Anorexia Nervosa
12 consecutive patients fulfilling the inclusion criteria and consenting to participate in the research, recruted in the three inclusion centers.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of serious adverse event
Time Frame: Through study completion (2 years)
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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. |
Through study completion (2 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of protocol acceptability
Time Frame: At the end of the inclusions (2 years after study start)
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Number of patients meeting inclusion criteria and accepting treatment / Number of patients meeting inclusion criteria and offered treatment
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At the end of the inclusions (2 years after study start)
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BMI Monitoring
Time Frame: Through study completion (each month), during 2 years
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Variation of BMI.
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Through study completion (each month), during 2 years
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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
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Pupillometry according to GHU PARIS Sainte Anne Clinique des Maladies Mentales et de l'Encéphale protocol.
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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
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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
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The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears.
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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
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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
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measure of temporal discounting, the tendency for people to prefer smaller, immediate monetary rewards over larger, delayed rewards
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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
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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
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Measures the ability to detect rules in sequences of stimuli.
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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
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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
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assess executive function
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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
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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
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measure habit tendencies, the likelihood of making erroneous responses for devalued outcome
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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
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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
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measure the ability to display flexibility in the face of changing schedules of reinforcement
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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
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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
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screening assessment for detecting cognitive impairment
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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
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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
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Assess the verbal episodic memory
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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
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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
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measure of constructional praxis and visual recall
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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
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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
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detect states of depression and anxiety
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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
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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
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Rate the severity of obsessive-compulsive disorder symptoms
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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
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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
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Measures the current intensity of patients' specific attitudes, behaviors, and plans to commit suicide on the day of the interview.
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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
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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
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measure of health status
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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
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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
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Rate subjectively the social, occupational, and psychological functioning of an individual
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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
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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
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Assess caregiving burden in clinical and research settings
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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
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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
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measure of constructional praxis and visual recall
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D21-P014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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