There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Seminal studies in motor neuroscience involving healthy subjects have revealed time-locked changes in induced power within specific frequency bands. Brain recordings were shown to exhibit a gradual reduction in signal power, relative to baseline, in the mu and beta frequency bands during an action or during motor imagery: the event-related desynchronization (ERD). This is considered to reflect processes related to movement preparation and execution and is particularly pronounced in the contralateral sensorimotor cortex. Shortly following the completion of the task, a relative increase in power, the event-related synchronization (ERS), could be observed in the beta band. ERS is thought to reflect the re-establishment of inhibition in the same area. Ever since the characterization of the ERD and ERS phenomena, there has been little to no discussion in the field of non-invasive Brain Computer Interfaces (BCI) as to whether these features accurately capture the task-related modulations of brain activity. Recent studies in neurophysiology have demonstrated that the ERD and ERS patterns only emerge as a result of averaging signal power over multiple trials. On a single trial level, beta band activity occurs in short, transient events, bursts, rather than as sustained oscillations. This indicates that the ERD and ERS patterns reflect accumulated, time-varying changes in the burst probability during each trial. Thus, beta bursts may carry more behaviourally relevant information than averaged beta band power. Studies in humans involving arm movements have established a link between the timing of sensorimotor beta bursts and response times before movement, as well as behavioural errors post-movement. Beta burst activity in frontal areas has also been shown to correlate with movement cancellation and recent studies show that activity at the motor unit level also occurs in a transient manner, which is time-locked to sensorimotor beta bursts. Although beta burst rate has been shown to carry significant information, it still comprises a rather simplistic representation of the underlying activity. Indeed, complex burst waveforms are embedded in the raw signals, and can be characterized by a stereotypical average shape with large variability around it. The waveform features are neglected in standard BCI approaches, because conventional signal processing methods generally presuppose sustained, oscillatory and stationary signals, and are thus inherently unsuitable for analysing transient activity. In contrast to beta, activity in the mu frequency band is oscillatory even in single trials. This activity is typically analysed using time-frequency decomposition techniques, which assume that the underlying signal is sinusoidal. However, there is now growing consensus that oscillatory neural activity is often non-sinusoidal and that the raw waveform shape can be informative of movement. In this project, the design of a subject-specific neurophysiological model to guide motor BCI training will be optimized using Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) for high spatial and biophysical specificity in the experimental group. Anatomical MR volumes will be used to design and 3D-print an individual head cast that will be used in the MEG scanner to stabilize the head position and minimize movements. This high-precision approach (hpMEG) has been proven to significantly improve source localization up to the level of distinguishing laminar activity, which makes it superior to EEG recording technique. An individualized hpMEG approach, as well as the widely adopted EEG, will be used to study bursts of oscillatory activity in the beta and mu frequency bands related to motor imagery and motor execution. hpMEG will yield subject-specific models of motor imagery that will be used to constrain online decoding of EEG data. This approach will be applied and validated on a group of healthy adult subjects and will then be compared against another feasibility group of patients and age-matched healthy participants. The proposed approach will be compared with a classic EEG-based BCI approach. The information will be used to optimally guide subsequent EEG-based BCI training in the control group. After a thorough investigation in healthy subjects in this project, the feasibility of the approach will be evaluated in a few stroke patients with upper-limb motor deficits. Tasks 1.1 and 1.2 aim to develop subject-specific generative models decoding movement onset and offset, the type of movement, as well as finely discretized movement amplitude during both real and imagined wrist extensions/flexions. Task 1.2 investigates how lesions of patients alter our ability to decode attempted wrist movements.
Clinical evaluation of vaccines against respiratory viruses is currently based on the analysis of systemic immune responses, whereas respiratory immunity is the first line of defense against respiratory pathogens. In addition to secretory immunoglobulin A (IgA) in mucosal fluids which are essential to neutralize the pathogens at mucosal surfaces, tissue-resident memory immune cells have been shown to be crucial in protection. Furthermore, memory immune cells in blood able to migrate to airway tissues also play a crucial role. Airway immune responses have not been studied a lot due to the lack of a standardized methodology to evaluate them in humans.
EMDR is a psychotherapeutic approach recommended by the World Health Organization (WHO) for the treatment of disorders such as post-traumatic stress disorder, anxiety, depression and, more generally, psychological distress. In all these disorders, intrusions are one of the symptoms leading to intense emotional distress. EMDR therapy, by making intrusions less emotional and less present in the mind (i.e. less vivid), would reduce psychological distress. This symptomatological reduction would be made possible by the therapist's application of alternating bilateral visual (rapid eye movements following a point from left to right), auditory (tones emitted alternately in the right ear and then in the left ear) and/or tactile (tapping with fingers on the left and right shoulders alternately) stimulations administered while the patient concentrates on his or her intrusive thoughts. Accordingly, the aim of this research is to investigate the efficacy of self-administration of Alternating Bilateral Stimulations (ABS), on the emotional intensity (emotionality) associated with negative intrusive thoughts (or intrusions).
Cerebellar ataxias are a group of rare neurological disorders that are clinically and genetically heterogeneous, with several hundred genes and diseases known to date. Over the last decade, their diagnosis has been revolutionised by the development of high-throughput sequencing technologies such as exome/genome sequencing (ES/GS), making it possible to obtain a molecular diagnosis in a growing number of patients. However, almost 40% of patients remain without a molecular diagnosis, raising questions about the limitations of sequencing technologies based on a technique known as short-read. One limitation of short-read is its poor ability to detect repeated motif expansions, a frequent mechanism in neurology and associated with more than thirty neurogenetic diseases. Although tools for analysing ES/GS data have gradually been developed in response to this problem, their effectiveness and reliability remain moderate. To date, the gold standard for detecting these expansions remains targeted approaches such as PCR and Southern blot, which are long, tedious and costly processes that require an independent search for each expansion, forcing clinicians to select expansions and limiting diagnostic yield. In addition, there are diseases associated with expansions so rare that no French laboratory offers a diagnostic test. The recent development of long fragment genome sequencing (long-read - lrGS) could provide a solution to all these problems. These technologies are based on a sequencing process during which DNA is preserved in the form of large molecules of several tens of thousands of bases. Regions of the genome containing expansions can therefore be studied directly in their entirety, avoiding the difficulties of reconstruction from small fragments, which is the case in short-read sequencing. In addition, lrGS can characterize the size of repeated motifs and thus detect any causal expansion in an individual in a single analysis. A number of recently published studies, particularly in neurology, have demonstrated the ability of lrGS to detect pathologies with known expansions (SCA36, C9ORF72), but also to discover new ones and thus explain the molecular basis of rare pathologies (SCA27b, NOTCH2NLC). Although these sequencing technologies have been around for a number of years, access is still restricted to research work and is limited by their higher cost. Their value as a second-line diagnostic tool has yet to be demonstrated. The investigators propose to evaluate the feasibility and diagnostic yield of Oxford Nanopore lrGS in duo or trio (patients + 1 or 2 first-degree relatives) in patients with cerebellar ataxia without molecular diagnosis after short-read GS. This will be the first study to transfer this lrGS technique to the second line, in real-life conditions, for the causal genetic diagnosis of cerebellar ataxia.
The aim is to describe the incidence, characteristics, risk factors and outcome of complications acquired under mechanical ventilation (called ventilator-associated events) according to the new CDC criteria, in a population of patients admitted in intensive care unit after cardiac arrest.
Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated. Consequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.
This is a multicenter, controlled, non-randomized interventional clinical study, with minimal risks and constraints, aimed at verifying the reliability of the French version of the VRSQ questionnaire (VRSQ-F) and the validity of the VRSQ-F score by comparing it with the SSQ score.
The goal of this clinical investigation is to evaluate the effectiveness on pain of arterial occlusion (embolization) of neovessels by microparticle in a double-blind sham controlled randomised trial in patients with persistent pain on a total knee prosthesis (TKP), inserted for gonarthrosis, despite well-conducted medical treatment. The study patient population will consist of up to 112 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or saline in the sham arm. The efficacy of embolization will be judged on the basis of the following criteria: improvement in pain, mobility, use of pain medication, adverse effects of embolization and duration of improvement. After verification of eligibility criteria, patients with painful total knee prosthesis will be randomized to either the embolization group or the control group. Embolization will be performed using microparticles (Embozene® Microspheres 100 microns from Varian), for the treatment group. For the "sham " group, only diagnostic arteriography will be performed without injection of microparticles. Subjects will be followed up at 1, 3, 6 and 12 months.
Dentin hypersensitivity (DH) results in brief, sharp pain in response to a stimulus. It often seems to be underdiagnosed but also undertreated due to the lack of consensus on the topic. DH has been shown to affects patients' quality of life. The Dentine Hypersensitivity Experience Questionnaire (DHEQ)is developed and validated : which is questionnaire assessing specifically the impact of DH on patient's quality of life. The DHEQ aims to help diagnose DH and assess the impact and subjective experience of the patient in order to better meet their expectations in terms of treatment. A French version, the DHEQ-fr, has been proposed (translation-counter-translation process and pilot study); however, it has not yet been validated (psychometric tests, test-retest). The main objective of the present study is to validate DHEQ-fr through a multicenter clinical study (three centers in France) in adult patients. The secondary objective is to compare the results of DHEQ-fr with those of the general oral health assessment index and oral health impact profil for the same patients. Patients are split between three DH groups (Schiff scores 1, 2 and 3) and a control group (non-DH). The overall sample size (all centers considered) for the DH group is 162 subjects divided into 54 subjects for each Schiff score (1 to 3; after cold air stimulation), with a control group of 54 subjects. A re-test will be performed, at 15 days, on a random sample of 60 subjects from the study population (in total: 15 non-DH subjects; 15 with a Schiff score of 1; 15 with a score of 2; 15 with a score of 3). The study of psychometric properties such as acceptability, internal consistency, reproducibility and internal structure validity will allow the validation of this French version of the DHEQ.
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients will be followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.