Clinical trials

The goal of this clinical trial is to improve non-invasive identification of epileptogenic networks in drug-resistant epileptic patient. The investigators aim to compare epileptogenic network identification with stereo-EEG (used as glod standard) with the identification of the same network using advanced MRI (rs-fMRI, microstructural analysis of white matter, ...). The main goals are to: 1. Compare the accuracy of network identification. 2. Analyse the effect of the MRI sequences on candidates selection and target identification. Participants will already have been selected for stereoEEG and will undergo a supplementary MRI (about 1h) with the additional MRI sequences. Follow-up MRI are scheduled for patient undergoing a second, therapeutic epileptic surgery.

This study aims to evaluate whether adding a continuous mist of saltwater (saline nebulization) to warmed, humidified air can improve the properties of mucus in the lungs compared to humidified air alone. Some patients with chronic lung diseases produce large amounts of thick mucus, which can be difficult to clear and may worsen breathing. Making this mucus easier to move and remove could help improve comfort and breathing. In this study, 35 adult patients hospitalized for lung conditions with excessive mucus production will participate. Each patient will receive both treatments on two different days, in a random order: Heated humidified air alone Heated humidified air combined with continuous saline nebulization This design allows each patient to serve as their own comparison. At the beginning and end of each session, a physiotherapist will help patients clear their airways, and mucus samples will be collected. Each treatment session will last 4 hours. The collected mucus will be analyzed in a laboratory to measure how thick, sticky, or elastic it is, and how much force is needed to move it. The main goal is to determine whether the combined treatment makes mucus easier to clear. The study will also assess patient comfort, breathing difficulty, ease of clearing mucus, and sleep quality after treatment. The results of this study may help improve airway care for patients with chronic lung diseases by identifying more effective ways to manage excessive mucus.

The use of mechanical insufflation-exsufflation (MI-E) in children with neuromuscular diseases (NMD) is recommended by international guidelines and societies and well documented. Many authors have shown that MI-E is safe and effective for airway clearance and has a significant benefit in reducing the duration of the airway clearance session in children with respiratory infections and atelectasis or in the postoperative period. However, its use in paediatrics is still poorly supervised and learning the technique is too often therapist- and/or patient-dependent. The use of a protocol or means of help to guide the initiation and learning of MI-E would allow better use, better adaptation of the settings and potentially better compliance with the treatment. The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone.This randomized controlled study will first include healthy children, aged 6 to 12 years, with no history or recent respiratory infection affecting lung function or other chronic diseases. In a second phase, the investigators will test the use of the learning process in children with neuromuscular diseases. The investigators hope that the results of this study will provide a better framework for the learning and effectiveness of MI-E. Furthermore, if the results are positive, this will allow better support for the use of MI-E in chronic treatments and help to ensure that this costly treatment for hospitals and public health is used efficiently.

Acute low back pain is a common reason for emergency department visits (4.39% \[95% CI: 3.67-5.18\]). Drug treatment options are limited and largely ineffective. Paracetamol and opioids are no better than placebo for acute low back pain. Only NSAIDs and muscle relaxants have a slightly beneficial effect on pain, but muscle relaxants have an unfavorable benefit-risk ratio. Given this situation, it is necessary to explore new non-pharmacological treatment options to relieve the pain of these patients. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological therapy that involves applying an electrical current through the skin. Using one or two pairs of electrodes attached to the skin, TENS delivers painless, low-intensity electrical pulses to a painful area or along the path of a nerve. TENS works by selectively activating large-diameter, non-nociceptive afferent fibers to induce segmental analgesia. In addition, TENS increases the concentration of endorphins in the bloodstream and cerebrospinal fluid. The use of TENS has been studied primarily in chronic low back pain. A 2007 Cochrane systematic review concluded that TENS appears to reduce pain and improve range of motion in subjects with chronic low back pain. The use of TENS in the emergency department has been little studied. To our knowledge, there are no high-quality studies comparing TENS versus placebo for acute low back pain in patients presenting to an emergency department. This study aims to investigate the analgesic efficacy of TENS compared to placebo in the treatment of acute low back pain in the emergency department.

The METAB-BELGROW-LAGH study aims to prospectively evaluate the metabolic outcomes of Belgian children diagnosed with growth hormone deficiency (GHD) over a three-year period following the initiation of treatment with either daily recombinant human growth hormone (rhGH) or weekly long-acting growth hormone (LAGH). Patients will be stratified according to their IGF-1 levels. The primary objective is to assess the metabolic outcomes of children treated with daily rhGH over the first three years. The secondary objectives include comparing the metabolic outcomes between patients treated with daily rhGH and those treated with weekly LAGH, and characterizing metabolic profiles based on IGF-1 levels. To achieve these objectives, both standard-of-care (SOC) and additional data will be collected at scheduled follow-up visits (baseline, 6, 12, 24, and 36 months), including clinical, auxological, and biological parameters. Additional metabolic markers, inflammatory and endothelial biomarkers will be assessed. In a subset of patients, carotid intima-media thickness (cIMT) and body fat distribution (via DEXA-scan) will also be measured.

Lower EEG alpha band power is currently extensively studied as a potential biomarker of brain vulnerability. No previous study has evaluated whether there was a difference in EEG power spectrum ranges between propofol and sevoflurane, the two main anesthetic agents for maintenance of general anesthesia, in order to define a cut-off value for the prediction of a higher risk of postoperative delirium. * Primary objective: comparison of EEG alpha power (dB) during maintenance of anesthesia with propofol and sevoflurane using data available in the NeuroSense® depth-of-anesthesia monitoring * Secondary objectives: comparison of other EEG frequency bands during maintenance of anesthesia with propofol and sevoflurane using data from the NeuroSense® depth-of-anesthesia monitoring

The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are: * Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD? * Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS? Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.

Many medical specialties and paramedical fields are increasingly using point-of-care ultrasound (PoCUS). In daily practice, thoracic and abdominal pain constitute a significant portion of emergency department consultations. PoCUS can be employed in various ways during thoracic and abdominal physical examinations. Most scientific societies advocate for its use to address specific clinical questions rather than to provide a definitive diagnosis. The integration of PoCUS into clinical examinations raises the question of its effectiveness in improving the diagnostic approach, rather than its diagnostic accuracy alone. Given the broad spectrum of differential diagnoses for thoracic and abdominal pain, this multicenter prospective study protocol aims to evaluate how PoCUS enhances the diagnostic approach for patients presenting with these symptoms in the emergency department. To assess the contribution of PoCUS, three members of an adjudication committee will blindly choose between two case report forms reporting the planned diagnostic approach for each patient: one completed before PoCUS and the other after its use by the investigator handling the case. The hypothesis that PoCUS improves the diagnostic approach by 60% will be reached if 60% of the improved diagnostic approaches favor the case report form filled out after PoCUS.

The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are : * Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ? * Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster? * Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ? Participants will : * Complete auto-questionnaires * Pass hetero-evaluations * Undergo an electrophysiological battery

The study is experimental and aims to (a) compare the viscoelastic properties of bronchial secretions obtained in patients suffering from obstructive respiratory disease, and (b) to compare the viscoelastic properties of bronchial secretions obtained in patients before and after application of a respiratory physiotherapy or exercise as usually prescribed. After agreement, the sputum of the participants will be collected according to the method used in clinical routine.Experiments (collection and analysis of sputum) will be conducted at the Saint-Luc University Clinic.

Neurological pathologies cause important and permanent disabilities in every day life. These pathologies can follow stoke, affecting two people per one thousand each year or cerebral palsy, affecting two births per one thousand each year. To date, the diagnosis and the rehabilitation of motor and cognitive problems has been carried out separately by different domains. For example, physiotherapists have focused on motor problems and neuropsychologists have focused on cognitive functions. However, a number of studies have demonstrated a link between motor and cognitive abilities in adults and children. The present study has three main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients (all ages), (2) to understand the link between motor and cognitive abilities in patients and healthy participants and, (3) to propose new types of therapies based on the link between motor and cognitive functions.

Recent work has confirmed the diagnostic performance of pseudo-CT sequences for detecting osteolytic lesions. Their integration into whole body MRI (WB MRI) could transform the diagnostic approach to MM, by allowing a combined assessment of bone marrow involvement, tissue viability and osteolysis, during a single non-irradiating imaging examination. Since the preliminary work mentioned above, optimizations have been made to the pseudo-CT sequences, including the addition of deep learning (correcting noise in the images) and the correction of chemical shift artifact (linked to the coexistence of hydrated tissue and fatty tissue), which carry real hope of improving their diagnostic potential and accuracy.

The goal of this exploratory interventional study aims to evaluate the performance of "pseudo-scanner" MRI sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

It is possible to perform a pelvimetry by MRI as a substitute to pelvimetry by CT, hence sparing the patient from a dose of irradiation.

This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Secondary objectives include evaluating the effects of HFT on dyspnea, patient comfort, and secretion appearance. The study will take place at Cliniques Universitaires Saint-Luc, with adult tracheostomized patients undergoing standard care.

This study aims to evaluate the relevance of using point-of-care lung ultrasound (LUS) in modifying the physiotherapist's treatment plan for patients hospitalized in a general ward.

This is a pilot clinical trial to evaluate the feasibility and outcome of autologous transplantation of immature testicular tissue cryopreserved during childhood as a method of fertility preservation for prepubertal boys in case of gonadotoxic therapies. Freezing of immature testicular tissue is performed since the early 2000s and a number of our patients have now reached reproductive age. In case of childwish and azoospermia in adulthood, surgical sperm retrieval is planned and if unsucessful transplantation of the patient's own cryopreserved tissue will be performed during the same surgical intervention as a fertility restoration method.

Cardiac arrest (CA) remains a major cause of mortality and long-term neurological disability worldwide. Despite advances in resuscitation, many survivors suffer from post-cardiac syndrome encompassing PCAS brain injury (PCABI), due to primary (ischemic) and secondary (reperfusion) injury, myocardial dysfunction, systemic response, and persistent underlying causes. PCABI plays a critical role in this complex condition, which is characterized by ischemia, inflammation, and microvascular dysfunction.Current methods to predict neurological outcomes are limited, leading to challenges in clinical decision-making and the risk of premature withdrawal of life-sustaining therapies. This study aims to improve prognostication in CA patients by integrating advanced serum biomarker profiling with cerebral ultrasound (CU) techniques. The investigators hypothesize that combining these tools with clinical data will enhance the accuracy of neurological outcome predictions and deepen understanding of PCABI pathophysiology. The investigators will prospectively enroll 50 CA patients admitted to the intensive care unit at Cliniques Universitaires Saint-Luc. Serum proteomics will be performed using the Reveal panel from Olink®, which analyzes over 1,000 proteins involved in inflammation and thrombosis implicated in PCABI. Concurrently, cerebral ultrasound will assess optic nerve sheath diameter (ONSD) and cerebral blood flow velocities (CBFV) at multiple time points post-resuscitation (at admission, on day 1-2 and on day 3-5). These non-invasive bedside measurements may serve as early indicators of elevated intracranial pressure and cerebral hemodynamic abnormalities.The primary endpoint is poor neurological outcome at one month, defined by the Cerebral Performance Category (CPC) scale. Statistical analyses will evaluate the prognostic value of biomarkers and ultrasound parameters individually and in combination with established clinical predictors.This multimodal approach promises to refine prognostic accuracy, improve clinical decision-making, and identify novel therapeutic targets. Ultimately, our findings may lead to improved patient outcomes and guide future multicenter studies for validation and clinical implementation.

This prospective clinical study compares patient-reported outcome measures (PROMs) after adaptive or conventional radiotherapy in prostate cancer. Adaptive radiotherapy (ART) aims to reduce uncertainties related to daily anatomical variations, thereby improving treatment accuracy while decreasing gastrointestinal (GI) and genitourinary (GU) toxicity. This study, conducted at Cliniques universitaires Saint-Luc (Brussels and Ottignies sites), analyzes and compares toxicities in patients treated with ART on Ethos and those treated with conventional radiotherapy on Halcyon. The primary objective of the study is to demonstrate that ART reduces gastrointestinal, urinary, and general side effects induced by radiotherapy. Additionally, the secondary objectives include assessing the duration of these effects, correlating them with dosimetric data, analyzing the management of toxicities through the Noona e-health application, as well as evaluating the use of this application by both patients and healthcare providers. The study includes men aged 18 years or older with prostate cancer undergoing curative-intent treatment, with an ECOG performance status of 0 to 1, and able to use the Noona application. Patients with a history of rectal or bladder treatment, or those who have already received pelvic radiotherapy, are excluded. Two groups are compared: patients treated with conventional radiotherapy on Halcyon (Ottignies site) and those treated with adaptive radiotherapy on Ethos (Brussels site).

The objective of the BELGICA trial is to evaluate if radiotherapy could be given in a more focused manner in patients with glioblastoma in order to reduce side effects and improve quality of life. The glioblastoma (GBM) is the most common and aggressive tumour originating from the brain, affecting approximately 600 patients per year in Belgium. The treatment consists in surgical resection of the tumour (when feasible), followed by a combination of radiotherapy and chemotherapy. Despite multimodal treatment (surgery, radiotherapy, and chemotherapy), the life expectancy of patients with GBM remains limited, with an average survival of 12-18 months and only 5% of patients surviving more than 5 years. In addition to limited survival, most patients with GBM experience impaired quality of life, both because of the disease and treatments. Radiotherapy is a treatment where radiation is used to kill cancer cells. In GBM, radiotherapy is targeted at the tumour (or tumour bed if the tumour was resected) with a safety margin around it (the "Clinical Target Volume" or CTV) to account for potential microscopic spread of the tumour. The downside of this safety margin is that a substantial amount of brain tissue is irradiated, which can lead to treatment toxicity. Reducing the CTV margin would enable to decrease the volume of brain being irradiated and could thereby allow to reduce the side effects of brain irradiation. The BELGICA trial (Achieving a BEtter outcome through Limiting the GlIoblastoma Clinical tArget volume) is a national multicentre trial which will evaluate if reducing the irradiation volume in glioblastoma is safe and allows for lowering side effects and improving quality of life.

The aim of this study is to investigate the technical feasibility of brain radiotherapy without immobilization masks using surface imaging to ensure accurate patient positioning and continuous motion monitoring.

* Primary Objective: To evaluate the effects of complementary exercise protocols in cardiac rehabilitation (CR), such as inspiratory muscle training (IMT), by assessing inspiratory muscle strength. * Secondary Objectives: To assess functional capacity, quality of life (QoL), and pulmonary function.

Acute low back pain is a frequent cause of emergency department admissions (4.39% \[95% CI: 3.67-5.18\])1. Drug therapeutic options are limited and ineffective. Paracetamol and opioids are no better than placebo for acute low-back pain 2,3. Only NSAIDs and muscle relaxants have a slightly beneficial effect on pain, but muscle relaxants have an unfavorable risk-benefit balance.2 In this situation, it is necessary to turn to new non-drug therapeutic options to relieve pain of these patients. Transcutaneous electrical nerve stimulation (TENS) is a non-drug therapy that involves applying an electrical current through the skin. Through one or two pairs of electrodes stuck to the skin, TENS delivers painless, low-intensity electrical impulses to a painful area or a nerve pathway. TENS acts by selectively activating large-diameter non-nociceptive afferent fibers to induce segmental analgesia4. In addition, TENS increases the concentration of endorphins in the bloodstream and cerebrospinal fluid5. The use of TENS has been studied mainly in chronic low-back pain. A 2007 Cochrane systematic review concluded that TENS appears to reduce pain and improve range of motion for subjects with chronic low back pain6. The use of TENS in emergency departments has been little studied. A 2018 pilot study of 110 patients admitted to the emergency department with acute or chronic pain observed a reduction in pain (from an average of 8.50 on the numerical pain scale \[EN\] \[7.52 - 9.48\] to 4.67 \[3.51 - 5.89\]) after TENS use and functional improvement in 83% of patients7. The Gulacti study, carried out in 2022, investigated the use of TENS to treat pain of patients admitted to the emergency department with a renal colic attack : the mean reduction in VAS score at 15 and 30 minutes was significantly greater for the TENS group than for the placebo group (mean reduction in VAS score at 15 minutes was 33.3 ± 17.6 (95% CI : 28.3 to 38.3) for the TENS group and 14.9 ± 11.6 (95% CI: 11.6 to 18.2) for the placebo group \[mean difference: 18.4 (95% CI: 12.5 to 24.4, P \< 0.0001)\]. The mean reduction in VAS score after 30 minutes was 63.7 ± 21.1 (95% CI: 57.7 to 69.7) for the TENS group and 14.9 ± 16.2 (95% CI: 19.5 to 10.3) for the placebo group (mean difference: 48.8, 95% CI: 41.4 to 56.3, P \< 0.0001)8. A single study of 76 patients focused on acute low-back pain during patient transport to emergency departments. The authors recorded a significant reduction (p= 0.01) in pain during transport of the TENS group (79.2 ± 6.5 mm VAS to 48.9 ± 8.2 0 mm VAS), while pain scores remained unchanged for the placebo group (75.9 ± 16.4 mm VAS and 77.1 ± 11.2 mm VAS)9. To our knowledge, there is no high-quality study of TENS versus placebo for acute low back pain of patients admitted to an emergency department. 1. Primary objective: Study the analgesic efficacy of TENS compared to placebo in the treatment of acute low back pain at the emergency department. 2. Secondary objective: 1\. Compare the number of patients who will show a \> 50% reduction of their initial pain. 2\. Compare the number of patients requiring rescue treatment. 3. Compare the occurrence of side effects among groups. 4. Compare patient satisfaction after 30 minutes. 5. Compare patient comfort level after 30 minutes. Main criterion: Comparison of the proportion of patients with \>30% reduction of initial pain after 30 minutes of treatment Secondary criterion: 1. Proportion of patients with \> 50% reduction of their initial pain after 30 minutes of treatment. 2. Proportion of patients requiring morphine titration for pain relief. 3. The rate of side-effects associated with the use of TENS. 4. The level of satisfaction measured by numerical satisfaction scale ranging from 0 (not at all satisfied) to 10 (extremely satisfied) EN. A patient will be considered very satisfied if he/she presents a satisfaction level ≥ 8. 5. The level of comfort will be assessed by a comfort scale ranging from 0 (not at all comfortable) to 10 (very comfortable patient).

Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.

An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Propofol, the intravenous anesthetic of choice (rapid-acting and short-acting), and remifentanil (an ultra-short-acting opioid analgesic) are generally combined. The potential impact of these agents used for egg retrieval on egg fertilization and embryo quality is of interest. Indeed, certain drugs such as propofol could accumulate in the follicular fluid. The few studies conducted to date show contradictory results. While a harmful effect appears to be reported in experimental studies on mice, this effect is uncertain in clinical studies. Given this uncertainty, any method aimed at reducing propofol consumption in this context may be of interest. Virtual reality hypnosis (VRH) is a digital tool that has already been shown to be effective in reducing preoperative anxiety during oocyte retrieval. Furthermore, VRH has also demonstrated analgesic effects. The primary objective of this study is to compare VRH with a control group (usual sedation) on propofol consumption during oocyte retrieval. Secondary objectives are to compare preoperative anxiety, APAIS score, catastrophizing score, remifentanil consumption, intra- and/or post-operative nausea and vomiting, post-procedural analgesic consumption, time perception during the procedure, fertilization parameters, and pregnancy rate at 12 weeks. The degrees of absorption, dissociation, immersion, and presence for the VRH group will also be noted.