Yorkhill, Glasgow, United Kingdom

Telemonitoring in Cochlear Implant Patient Care

In December 2020, the French Medical Device and Health Technology Evaluation Committee (CNEDiMTS) voted in favour of the integration of telemonitoring in cochlear implant users' follow-up thus adding a range of new possibilities to a standard health care routine. According to the official recommendations of the French National Authority for Health, a patient implanted for a sufficiently long time should be seen annually at the implantation reference center. This periodicity might appear too low, in which case a patient will have to organise an unscheduled check-up appointment. Such appointments are a source of various problems: firstly, they disorganise the routine of the reference centers not adapted for emergency and semi-emergency situations; secondly, the patient might encounter substantial travelling fees (only 22 refence centers in France), especially if an implant component to replace is out of stock. Having an utility of remote patient monitoring is also beneficial in situations where the access to health care system is restricted, for example, the recent pandemic of Covid 19. Cochlear™ has recently designed an at-home based patient testing tool, Remote Check application, permitting to complete a series of hearing test from a compatible smartphone. The results are then sent to the implantation reference center and evaluated by healthcare professionals. The data is securely stored on Cloud accessible to authorised clinicians via MyCochlear site. Although the feasibility and the accuracy in detecting technical problems of remote follow-up of people with cochlear implant had been already assessed, its impact on health care system is still unknown. Hence, this project will be the first to evaluate an interest of implementing remote monitoring in following adults with cochlear implantation. The main objective of the study is - to determine if the use of telemonitoring through Remote Check application reduces significantly a number of unscheduled check-up appointments in the reference centre during 1 year follow-up period for a patient with a cochlear implant Cochlear™ in comparison to traditional health care approach. The secondary objectives are: - To compare a number of scheduled appointments during a period of Remote Check use versus a historical period of a traditional follow-up - To compare a number of indispensable unscheduled visits (unavoidable with or without Remote Check use) with a number of unnecessary ones (avoidable with Remote Check) - To measure the compliance of the Remote Check application use - To assess quantitatively and qualitatively a number of implant failures/dysfunctions identified with Remote Check - To evaluate for each study participant time spent by clinician to treat Remote Check analysis data uploaded to My Cochlear data base - To assess patients satisfaction of Remote Check implementation in their healthcare routine - To evaluate the quality of life specific to the Deaf before and after Remote Check use The study implies four visits for each patient. The inclusion visit (V0) is a routine check-up appointment in the implantation reference center. After the patient is informed and his/her consent is collected, the Remote Check application will be activated on his/her processor. Two next follow-up visits, V1 (V0+ 5 mois (± 0.5 mois)) and V2 (V0 + 11 mois (± 0.5 mois)), are remote visits with hearing test performed through Remote Check application. Final visit, V3 (V0 + 12 mois (± 0.5 mois)), corresponds to patient's annual check-up appointment. In case a problem with processor's functioning is detected during V2, it will be resolved at V3. Equipment verification will be also performed to detect failures missed by Remote Check.

Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults

Bell's palsy (idiopathic peripheral facial palsy) is the most common cause of facial palsy, which is related to the inflammation of the facial nerve, possibly induced by herpesvirus reactivation. Its first-line treatment comprises corticosteroids, antiviral therapy and physiotherapy. In most severe cases (grade IV to VI on House-Brackmann scale), facial motricity may remain altered or develop synkinesis or post-paralytic spasm, thus tremendously affecting quality of life. The recovery of Bell's palsy is currently evaluated either by Sunnybrook Facial Grading System, House-Brackmann scale or Chevalier's method. It is nonetheless unpredictable, especially at the early stage of the disease. If the first-line treatment fails to provide a fast recovery, facial nerve decompression surgery may be proposed. Being rather complex and risky, this technique shows a lower efficiency if delayed from the onset. Surgical indication is based upon clinical and radiological criteria as well as electrophysiological measurements (electromyography - EMG and electromyoneurography - EMNG). EMG and ENMG methods have a somewhat limited predictive value, since 20 to 40% patients with severe Bell's palsy can recover without surgical treatment. Moreover, these measurements are not widely accessible and, in severe cases, they should be performed between 9 and 20 days from the onset. The surgery, in order to increase its success rate, should be performed in maximum 30 days, ideally in 14 days from the onset. Therefore, diagnostic and treatment of severe Bell's palsy face a double challenge: a narrow time window to provide a diagnostic and therapeutic strategy, and the need of a reliable prognostic methods to exclude the possibility of spontaneous recovery and thus to justify the surgical approach. Mass Spectrometry assay allows simultaneous detection of numerous proteins, to screen for inflammatory and neurodegenerative biomarkers at acute stage of Bell's palsy. Some of these proteins might appear of a prognostic value and will help to develop more reliable and personalised treatment approach of severe Bell's palsy. The primary objective of the study is to identify prognostic blood biomarkers related to the facial motricity recovery at 3 months from onset of severe Bell's palsy in adults. The secondary objectives are identification of the biomarkers related to the recovery speed in the first three months, and to the initial severity of Bell's palsy; evaluation of diagnostic performance of selected biomarkers; creation of a blood collection for further research on selected biomarkers. 130 patients referred by accident and emergency department will be enrolled during their appointments at the ENT Department of the University Hospital of Montpellier. BIOFIPS study implies 4 visits, with the overall duration of 3 months per patient. After patient information and consent, routine clinical examination, audiometric testing, tympanometry, acoustic reflex testing and Bell's palsy scoring will be performed. Patients will receive a medical prescription for a blood test an MRI to exclude other causes of facial palsy. At time of inclusion and 1 month after, they will be proposed to have a blood sampling for proteomic analysis. Then 125 biomarkers on a Peptiquant™ kit will be analysed by mass spectrometry, and prognostic biomarkers will be selected regarding to the clinical recovery of Bell's palsy.

Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.

After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). Project will monitor 30 chronic and 30 healthy subjects over one week period using two wrist worn sensors . The main objective is to objectively quantify by actimetry, over 7 days, the real functional use of the paretic upper limb in the activities of daily living of post-stroke hemiparetic subjects in chronic phase, by the functional use ratio between the two arms (UseRatio).

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

For both groups: At inclusion visit : - Patient information and signature of consent form - Randomisation - Previous medical history - Clinical exam - Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) : - Self-assessment of ADCT - Date of dupilumab injections - Batch number of dupilumab - Amount of topical corticosteroids Visits at M4, M8 and M12 will be performed for : - Clinical exam - Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events - Collect out-of-pocket expenses (M4 and M12).

Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Immediate Versus Delayed Treatment With Azathioprine or Rituximab in Anti-MOG Antibodies Associated Acute Demyelinating Syndromes in Children: a Randomized Controlled Clinical Trial

Acquired Demyelinating Syndrome (ADS) are rare immune-mediated central nervous system (CNS) disorders that contribute to significant neurological morbidity in Europe and worldwide. ADS can affect adult and children, and the clinical spectrum is heterogenous. It begins as monophasic diseases, as often observed in acute demyelinating encephalomyelitis (ADEM), optic neuritis (ON) and transverse myelitis (TM); or as multiphasic disease with relapses such as multiple sclerosis (MS) or neuromyelitis optica spectrum disorders (NMOSD). MOG-Abs-ADS are a frequent disease in children with ADS with specific clinical and MRI pattern. Recently, myelin oligodendrocyte glycoprotein (MOG) antibodies (MOG-Abs) have been found implicated in ADS affecting children with a frequency up to 30%-45% according to tested cohorts. Studies have shown that in MOG-Abs positive ADS, the most frequent clinical phenotype in children are ADEM-like presentations (ADEM, ADEM-optic neuritis, multiphasic demyelinating encephalomyelitis (MDEM) and encephalitis) and optic neuritis (ON). These presentations may vary according to the age and young children < or = 10 years old, most often, present with ADEM, whereas optic neuritis is the most common feature in children older than 10 years of age. Fewer patients present with myelitis, brainstem features, or the more recently described encephalitis with steroid-responsive seizures11. Cerebro-spinal fluid parameters are normal in most patients, although up to 50% had pleiocytosis or increased protein levels. Oligoclonal bands were present in only 10% of patients and their presence in the context of relapsing disease would rather suggest MS 5. MRI lesions are particular in MOG-Abs positive ADS: lesions are distributed in the cortex, subcortical region, deep white matter, brainstem, thalamus, basal ganglia and are characterized by poor demarcation and large size. These features have been found particularly in ADEM and MDEM and when compared to MOG-Abs negative ADS, large, hazy and bilateral lesions, an absence of small lesions and/or well-defined lesions, and involvement of more anatomical areas, often with longitudinally extensive transverse myelitis have been described. Absence of corpus callosal lesions, presence of cerebellar peduncle and leukodystrophy-like lesions were also observed in MOG-Ab-positive cases. MOG-Ab-associated optic neuritis is characterized on MRI by optic nerve head swelling, retrobulbar involvement, a long lesion length and, frequently, bilateral involvement. MOG-Abs-ADS are highly relapsing and may be associated with disabilities More than 40% of MOGAD relapse mimicking diseases such as MS or anti aquaporin 4 (AQP4-Abs) positive NMOSD with an higher relapse rate 6. In the French national retrospective study on anti-MOG-Abs positive ADS, it was observed that relapse occurred in 46% of included children with a median time of 10 months (range :1-305 months) after onset, results that are in line with studies in other European countries 9. Relapses are frequently observed during steroid weaning or within 2 months of steroid withdrawal 7, 9, 16-18. Most relapses occur in adults who are being treated with prednisolone <10 mg daily (range 0-25 mg) or in children who are receiving prednisolone <0.5 mg/kg daily. The duration of treatment might also be important. Patients whose treatment lasts for less than 3 months are twice as likely to relapse as those who are treated for longer, suggesting the need for a biomarker for the response to treatment. Several studies suggest that relapses occur in patients who remain seropositive despite treatment particularly in patients who often have high initial antibody titres. Studies in optic neuritis, the most common neurological symptom in MOG-Abs-ADS have demonstrated that severe damage to the optic nerve can be observed in MOG-Ab-associated disorders. The observed damage seems to be driven by the frequency of attacks in patients who recover from the initial episode suggesting the need of long term treatment. Moreover, although most patients with MOG-Ab-associated disease recover well from attacks, it has also been shown that up to 45% can be left with severe disability. Importantly, >70% of this disability results from the onset attack, suggesting that there is room for improvement in the acute management of MOG-Ab-associated disease, and that time to treatment might be important for the prevention of permanent disability. Recently, Bicêtre's hospital medical team have performed a multi-national collaborative study on 102 children with relapsing MOG-Abs-ADS (RADS) through a European Consortium coordinated by the coordinator of this project. In that study, it was observed that although the majority of children had low level clinical disability, 20% of affected children had cognitive impairment and investigators confirmed these results in the national cohort study where they have observed that age at onset < or = 10 years (OR, 3.72, 95%CI 1.19-11.64; p=0.024), ADEM at onset (OR 52.5, 95%CI 5.97-461.4; p<0.001), and deep grey matter lesions (OR, 17.33 95%CI 3.87-77.72; p<0.001) were associated to the presence of cognitive difficulties. Studies on prospective treatment of MOGAD are rare and current treatment is based on clinical experience with similar antibody-mediated diseases, such as AQP4-Abs positive NMOSD. Corticosteroids, intravenous immunoglobulin, immunosuppressive drugs (such as mycophenolate mofetil, azathioprine and methotrexate) and rituximab are actually used and are associated with a reduction in annual relapse rate. By contrast, immunomodulatory treatments for MS, such as interferon-β and glatiramer acetate, are ineffective. In a study of children and adults in Australia, maintenance treatment with oral prednisolone was associated with fewer treatment failures than were other treatment modalities, whereas in the European collaborative retrospective study of children with MOG-Abs, investigators were able to confirm that all treatment modalities reduced annualized relapse rates but had limited effects on disability. Due to the immense vacuum in the treatment strategies, investigators have also established established an European consensus on treatment and emphasized on the absolute need for a randomized controlled treatment trials to find an optimal therapeutical strategy in order to reduce risk of sequelae after the first attack and relapses that could reduce disabilities.

AI Performance for the Detection of Bone Fractures in Children