Issy Les Moulineaux

This research aims to find out how common cardiac amyloidosis is in older adults aged 80 years and above who have been hospitalized for heart failure and have thickening of the heart muscle (left ventricular hypertrophy). Patients will be recruited from 31 geriatric or cardiology centers over 24 months. Each participant will have a baseline visit where medical history, clinical data, frailty status, genetic testing, and heart ultrasound data will be collected. Bone scans using 99mTc-DPD or 99mTc-HMDP will be done during or after hospitalization to check for amyloidosis in the heart muscle. After the initial visit, participants will receive follow-up phone calls every 3 months for 12 months to track hospitalizations, nursing home admissions, and death. The main measure is the number of patients diagnosed with cardiac amyloidosis based on bone scintigraphy at the start of the study.

Alcohol Use Disorder (AUD) is a major preventable cause of death in France, yet only a small percentage of patients receive approved medications to reduce alcohol use or maintain abstinence. This research aims to compare two psycho-physical interventions for AUD: Mindfulness Based Relapse Prevention (MBRP) and an unguided meditative relaxation program. The study is based on the idea that MBRP may be more effective in reducing relapse and alcohol consumption than relaxation methods without guidance, especially since some patients do not fully benefit from cognitive and behavioral therapies (CBT).

Depression affects a significant portion of the population worldwide, with major depressive episodes (MDE) being a key feature of both Major Depressive Disorder (MDD) and bipolar disorder (BD). The study aims to evaluate the clinical impact and economic aspects of using the EDIT-Bae blood test to improve diagnosis and management of patients with bipolar disorder and major depression. This test may help reduce the average 7-year delay in diagnosing bipolar disorder, which is critical for timely and appropriate treatment. The study involves two groups of patients: one group will have the EDIT-Bae blood test with results available to guide treatment, while the control group will have the test but will not receive the results until the study ends. The EDIT-Bae test uses blood sample analysis and AI-based software interpretation to differentiate between bipolar disorder and major depression. Participants will be followed over six months, with four visits scheduled during this period. Participants will undergo assessments including symptom evaluations and monitoring of depressive symptoms over four months to measure improvement. The study will track health outcomes, diagnosis accuracy, and economic factors related to patient care. Safety and treatment effects will be observed throughout the six-month study duration to understand the benefits and impact of the EDIT-Bae test on managing major depressive episodes.

Sarcopenia is a condition characterized by the progressive loss of muscle mass and strength in older adults, leading to higher risks of falls, frailty, functional decline, and mortality. This research aims to develop a new diagnostic method for sarcopenia using high-definition surface electromyography (HD-sEMG) technology, which captures muscle activation signals. The study is multicentric, descriptive, cross-sectional, and involves parallel groups, focusing on people aged 75 years and older who are suspected of having sarcopenia based on the SARC-F screening questionnaire score. Participants will undergo muscle signal recording using HD-sEMG on the rectus femoris muscle during knee extension exercises either lying down or standing up from a chair, depending on their functional ability. Additional assessments include quadriceps muscle ultrasound performed at the bedside using a wireless handheld device and evaluation of physical activity using a questionnaire adapted for seniors. Body composition will be measured by bioimpedancemetry and, when possible, by dual X-ray absorptiometry (DEXA). Muscle strength will be tested through handgrip strength, and physical performance will also be assessed. During the study, participants' medical records will be reviewed for relevant clinical data. The primary outcome is the diagnostic score derived from electromyographic signals collected over seven days to differentiate sarcopenic from non-sarcopenic elderly individuals. The inclusion period will last 18 months, with an additional 3-month follow-up, totaling 21 months. This study seeks to provide a non-invasive and portable tool for sarcopenia diagnosis and monitoring, combining muscle mass and functional evaluation in older adults.

Chronic insomnia affects a significant portion of the French population, with around 15% to 20% experiencing this condition. The study aims to evaluate the effectiveness of auriculotherapy, specifically cryo-auriculotherapy, for treating chronic insomnia. This condition is typically managed by general practitioners using medications such as benzodiazepines and Z-drugs, but concerns exist regarding their long-term use due to side effects and dependency risks. The study focuses on patients diagnosed with chronic insomnia according to DSM-5 criteria and monitored in outpatient clinics at Foch Hospital or other participating centers. Participants will be divided into two groups: one receiving cryo-auriculotherapy using a device with nitrous oxide on 10 ear points, and the other receiving a sham treatment with the same device but without nitrous oxide. Each group will have three treatment sessions spaced one month apart. This setup allows comparison between real and sham interventions to assess the impact on sleep improvement. During the study, researchers will track insomnia improvements after three months of treatment. Participants will complete questionnaires like the Insomnia Severity Index, and adherence to treatment and study protocols will be monitored. Safety and any side effects will also be observed throughout the study period, which includes regular assessments to measure treatment effectiveness and participant well-being.

Researchers are evaluating the feasibility of a bronchopulmonary cancer screening program using thoracic CT scans within a dedicated, effective, and structured network in the Ile de France region. The study focuses on organizing screening based on criteria from the NELSON study, aiming to optimize early detection and management of bronchopulmonary cancer among eligible participants aged 50 to 74. The screening process involves several steps: first, identifying and recruiting eligible individuals; second, including participants through an online self-questionnaire and an inclusion visit at health centers; and third, performing an initial chest CT scan with dual interpretation. If cancer is suspected, participants are referred to a multidisciplinary team, and smokers are offered support through tobacco cessation units. Follow-up care and continued screening are also organized as part of the program. Participants will undergo assessments including eligibility consultations, chest CT scans, and follow-up visits coordinated by health center physicians. Researchers will monitor the rate of the first chest CT scan for bronchopulmonary cancer screening over 36 months. The study includes centralized image reading, interpretation, and management of cases. Safety and adherence are ensured through structured follow-up and referral systems within the network.

Researchers are investigating the use of botulinum toxin injections to prevent atrial fibrillation (AF) after cardiac surgery. AF is a common complication following heart surgery, occurring in 10 to 50% of patients, and can lead to serious health problems such as strokes, increased hospital stays, and higher medical costs. Previous animal studies have shown that injecting botulinum toxin into fat pads around the heart may reduce the chance of developing AF by blocking nerve activity. A preliminary human study suggested this approach is safe and feasible, prompting this larger phase 3 trial to evaluate its effectiveness and safety during the first three weeks after surgery. In this study, participants will be randomly assigned to receive either botulinum toxin type A injections or a placebo injection into the major epicardial fat pads around the pulmonary veins during cardiac surgery. The injections are given before the main surgical stage, during extracorporeal circulation and before aortic cross clamping, to minimize ischemia time. The toxin or placebo is injected into the four visible fat pads in the heart's epicardial area. This procedure aims to reduce postoperative AF by temporarily suppressing nerve activity that can trigger irregular heart rhythms. Participants will be monitored for episodes of atrial fibrillation lasting more than 30 seconds during the first three weeks after surgery. The study includes assessments such as electrocardiograms and clinical evaluations to track heart rhythm and safety. Researchers will also observe any serious adverse events. The trial requires patients to attend several consultations and will last through the postoperative period where AF risk is highest. The goal is to determine if botulinum toxin injections can reduce the need for antiarrhythmic drugs and anticoagulants, improving postoperative outcomes.

Depression is a common illness, affecting 17% of the population over the course of a lifetime. A third of depressions relapses and progresses to recurrence and resistance to treatments. Despite the optimization of antidepressant medical strategies, 20 to 40% of depressions do not respond to treatment. This is particularly worrying as 6% of non-responder patients will die by committing suicide. The term treatment-resistant depression (TRD) is used when two or more (and often many more) well conducted antidepressant treatments from different classes have failed to achieve remission. Depression has a major impact on quality of life, socio-professional functioning and healthcare consumption. According to the World Health Organization (WHO), depression will be the second cause of healthcare costs in the world by 2020. RD alone accounts for 30 to 40% of the annual cost of depression. Sometimes, TRD is part of a bipolar illness, a psychiatric condition characterized by the alternation of depressive and maniac episodes that affects 4% of the population. In this case, the challenge is even bigger because (1) antidepressants are no well tolerated, further reducing the therapeutic options in case of resistance, (2) the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients. Bipolar RD currently accounts for 20% of all psychiatric spending. The standard treatment for TRD is electroconvulsive therapy (ECT), which results in a response in 60 to 70% of cases after a few weeks of treatment. However, the improvement is often transient and 40% of patients relapse within 6 months of the initial ECT session. Moreover, ECT is often not well tolerated because of the frequency and the intensity of the memory disorders associated, the repetition of anesthesia and hospitalizations and its social stigma. Refusals and requests to stop ECT are therefore common even when it is effective, as these constraints are sometimes experienced as being unbearable in the long-term. This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response. The literature suggests that Vagus Nerve Stimulation (VNS) has unique kinetics of efficacy in depression, particularly in preventing the long-term recurrences, and therefore responding to the lack of effective maintenance treatment in TRD. In fact, the benefits of VNS gradually accumulate over 12-24 months, which makes it complementary to more incisive treatments like ECT. Finally, its efficacy-tolerance profile appears to be similar in uni and bipolar TRD, giving VNS a potentially unique place in the therapeutic arsenal in psychiatry. VNS has been approved for over 15 years as a treatment for RD in the Unites States and Great-Britain. The hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment. The primary objective is to estimate, from a collective point of view, the incremental cost-utility ratio of VNS to treat patients suffering from RD. The secondary objectives are evaluating the efficacy and the security of the VNS, as well as positioning the VNS in comparison with ECT that is currently the standard treatment for TRD. This is a national multicenter comparative, open, randomized, controlled, two-parallel group clinical trial evaluating the medico-economic impact of VNS in resistant depression population. Patients (166) suffering from resistant depression will be enrolled over a 24-month period and will be randomized in a (1:1) ratio to receive either Vagus Nerve Stimulation (VNS) along with the Best Medical Treatment (VNS+BMT arm) or the Optimal Medical Treatment only (BMT arm). Patients meeting all eligibility criteria will be enrolled in the study. All subjects will be followed by the investigators or designee of the investigator during the whole study period by visits on site. Number of visits/participant: Both arms will attend: selection visit (VS), inclusion visit (VI) and randomization visit (R), M0, M2, M4, M6, M8, M10, M12, M14, M16, M18, M20, M22 and M24. After the inclusion visit, the experimental arm (VNS + BMT) will further attend a neurosurgical and anesthetic consultation before being hospitalized for the VNS system placement. The patient will finally be hospitalized in psychiatry for about 5 days for switching the device on. If the target intensity has not been reached during this hospitalization, an adjustment visit is planned every month for 6 months in order to progressively increase the stimulation intensity until the target or a therapeutic response. If the target or the therapeutic response is obtained, the settings adjustments rhythm will be at the indiscretion of the psychiatrist. If at the end of the 6 first visits (M1 to M6), the target intensity couldn't be reached or in absence of a satisfying clinical response, a visit will be planned every 3 months (consultation or hospitalization) to keep optimizing the VNS.