Clinical Research Directory

Functional Outcomes and Control Using Synchron BCI - Canada

Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)

Cenobamate in the Intensive Care Unit

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH. Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

A Multicenter Pediatric Deep Brain Stimulation Registry

There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.

A Retrospective Survey-based Multicenter Study to Delineate the Molecular and Phenotypic Spectrum of Epilepsy-dyskinesia Syndromes

The Epilepsy-Dyskinesia Study aims to advance the understanding of the clinical and molecular spectrum of epilepsy-dyskinesia syndromes, monogenic diseases that cause both movement disorders and epilepsy. Addressing challenges in rare disease research -such as small, geographically dispersed patient populations and a lack of standardized protocols- the study employs a multinational retrospective survey endorsed by the International Parkinson and Movement Disorder Society. This survey seeks to collect comprehensive data on clinical features, disease progression, age of onset, genetic variants, and concurrent neurological conditions, standardizing data collection across countries to provide a unified understanding of these conditions. Through retrospective review and molecular data analysis, the study aims to identify patterns and correlations between movement and seizure disorders, uncovering genotype-phenotype relationships. The initiative\'s goals are to enhance understanding of epilepsy-dyskinesia syndromes, inform precision medicine approaches, and foster international collaboration.

Comparison of the Effects of Mirror Therapy,rTMS and Robotic-assisted Hand Therapy in Stroke Patients

The aim of the study is to investigate the comparison of the effects of mirror therapy, Repetitive Transcranial Magnetic Stimulation and robot-assisted hand therapy added to conventional neurological rehabilitation on upper extremity function, quality of life and pain in stroke.

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

The objective is to explore the potential short and long-term impact of the EXOPULSE Mollii Suit and EXOPULSE Suit on subjects with CP, MS, stroke, fibromyalgia or other neurologic disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvements in the Berg/Pediatric Balance Scale (BBS/PBS) as a measurement of balance and risk of falls.

The "What Is Important to Us" Communication Intervention Pilot Clinical Trial

The objective of this study is to conduct a pilot randomized controlled trial (RCT) of a photo-narrative communication intervention developed by our study team with patients/parents of children with severe neurological impairment (SNI) and their pediatric intensive care unit (PICU) clinicians to assess feasibility, acceptability, and early efficacy.

Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes

Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.

Advanced Imaging Holistic Omics Biobank

Imaging methods today represent the pillar of prevention, diagnosis, patients monitoring and treatment. Improvement in technology led the development of increasingly high-performance scanners whose potential has not yet been fully explored. In particular, recently introduced photon counting CT scanner and new high filed MRI offers a lake of latent information derived from the images (e.g. spectral data from CT) of potentially great interest and potentially able to provide new insight but that are currently mostly unexplored .These features are also called "opportunist features" because they are in each exam and can be freely derived from images without changing the study protocol used for clinical practice examination but extracted a posteriori from the images representing a precious source of deep characterization of the patients, equally or even more than a genomic analysis, with possible high relevance in the field of screening and prevention, being able to contribute to defining signatures indicating a particular risk of remotely developing a specific pathological condition. The prospective collection of clinical and imaging data from subjects undergoing diagnostic tests with advanced technology has the potential to increase knowledge of the pathophysiological mechanisms of different pathological conditions, to explore and validate the diagnostic-predictive value of opportunistic features not currently used in practice clinical, to increase the diagnostic and prognostic accuracy of CT and MRI examinations and to provide a unique pool for scientific research. Previous relevant experience was conducted in the United Kingdom (UK biobank) where data from over 500,000 patients have been collected in the last 10 years, providing an enormous pool for spontaneous and funded scientific research. This project (UK biobank), although of enormous scientific value, is currently obsolete in terms of the imaging technology used.

Ask Questions About Clinical Trials

The overall goal of this study is to assess the implementation of the Ask Questions about Clinical Trials (ASQ-CT) brochure, a patient-focused communication tool previously demonstrated to improve patient-provider communication about clinical trials. Participants will be given the ASQ-CT brochure at Time 1 (baseline) and participants will complete a questionnaire at three timepoints, baseline (Time 1), Pre-Research Visit (Time 2), and Post-Research Visit (Time 3).

Longitudinal Assessment of Protein Markers in the Cerebrospinal Fluid of Patients With Central Nervous System Involvement

In the context of adult pathology, research into biomarkers in cerebrospinal fluid (CSF) has already identified proteins that are commonly used for the early diagnosis of certain neurodegenerative diseases. However, the lack of data available in the literature on pediatric diseases has limited the use of biomarkers in routine practice in children. Importantly, our group has pioneered the establishment of CSF biomarkers in children (e.g., measurement of interferon alpha in CSF by ultra-sensitive digital ELISA), which will undoubtedly be used in routine clinical practice in the future. In light of these arguments, the establishment of a CSF biobank will have major clinical implications, given the rarity of the diseases treated and the number of patients followed.

A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea

This retrospective observational study aims to evaluate postoperative respiratory complications (PORC) after (adeno)tonsillectomy in children with OSA. In order to increase the number of patients available for analysis, we will merge data collected at UZA with data collected at the the Department of Sleep Laboratory and Sleep Surgery at the Heim Pal National Pediatric Institute, Hungary. These colleagues performed an identical prospective data collection.

Effectiveness of Music Therapy on Level of Consciousness

It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.

Prognostic Factors to Regain Consciousness

The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation. In this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.

Hippocampal Volume and Memory Functions in Aneurysmal Subarachnoid Hemorrhage

Neuropsychological and functional long-term consequences of subarachnoid hemorrhages (SAH) represent a great challenge, since sometimes considerable cognitive deficits occur without evidence of substantial brain damage. In this study, we want to examine if the frequently observed memory deficits are associated with hippocampal atrophy.

Magnesium and Cognition After Stroke

Cognitive impairments such as memory impairments, word-finding difficulties, compromised orientation and perception are often observed in stroke patients. Low serum-mg-concentrations are associated with cognitive impairments in ischemic stroke patients one month after stroke onset. It is not clear, if cognitive impairments after stroke is caused by the mg-deficiency or by the stroke itself. Until now, no studies investigating the relationship between mg-concentration, stroke severity and cognition during treatment course are available. Thus, this study aimed to investigate the relationship between mg-concentration and cognition of stroke patients.

Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain

The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.

Registry and Natural History of Epilepsy-Dyskinesia Syndromes

The Registry and Natural History of Epilepsy-Dyskinesia Syndromes is focused on gathering longitudinal clinical data as well as biological samples (blood, urine, and/or skin/tissue) from male and female patients, of all ages, who have a genetic diagnosis of epilepsy-dyskinesia syndromes. Through prospective review and molecular data analysis, the study aims to identify patterns and correlations between movement and seizure disorders, uncovering genotype-phenotype relationships. The initiative's goals are to enhance understanding of epilepsy-dyskinesia syndromes, inform precision medicine approaches, and foster international collaboration.

Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population

ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized techniques, and very few neurological patients. It seems appropriate to focus on neurological patients and to examine the influence of position on the detection of detrusor overactivity in these patients. The point here is to reexamine the ICS recommendations, which are not designed for neurological patients. Indeed, many patients suffering from Multiple Sclerosis (MS) or Parkinson's disease are unable to sit or stand for the duration of the urodynamic examination. The investigators would like to assess whether exploring sphincter disorders in the supine position is still interpretable. This would enable us to define ICS good practice recommendations for a neurological population.

Effect of Transcranial Direct Current Stimulation in Altered States of Consciousness

Transcranial Direct Current Stimulation (tDCS) is a non-invasive, painless brain stimulation treatment that uses low-intensity direct electrical currents to stimulate specific parts of the brain. Transcranial Direct Current Stimulation (tDCS) can both facilitate anodic stimulation and inhibit cathodic stimulation specific brain areas since many neurological and psychiatric disorders are connected to hypoactivity or hyperactivity in specific areas of the nervous system. This phenomenon is based on two processes: the reorganization of functional neural circuits and their reconstruction. In light of the studies mentioned above, it is presumed that Transcranial Direct Current Stimulation (tDCS) can be a valuable tool to facilitate the process of neuroplasticity in individuals with chronic neurological diseases and in patients with impaired consciousness following severe brain injury. A previous study demonstrated that a single session of transcranial direct current electrical stimulation could temporarily improve signs of consciousness in patients in a minimally conscious state (MCS)

An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.

This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites within the United States. Study subjects must meet a set of inclusion and exclusion criteria. Potential subjects arriving at the study sites will be evaluated for enrollment. It is the Principal Investigator's (PI) responsibility to enroll only subjects who satisfy the inclusion/exclusion criteria. Recruitment can occur by subject presentation at the sites for elective standard screening, word-of-mouth, flyers, healthcare professional (HCP) referrals, advertisement online, or any other means, subject to approval by the associated institutional review board (IRB) or ethics committee (EC) when applicable.

COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

Investigating Health Impacts of Exposure to Harmful Algal Blooms

The goals of this project are to study the biological effects of environmental toxins (ET), in particular aquatic toxins such as brevetoxins (PbTx) and microcystin or their metabolites. This study is designed to examine the effects of the body from harmful algae blooms (HAB) as well as possibility of an association between exposure to the marine toxin, brevetoxin (PbTx), which is released from K. brevis during the red tide bloom, and the prevalence of neurological illnesses.

Psychometric Properties of the Turkish Version of the Modified Mini Mental State Examination

One of the most commonly used screening tests for the mental status of adults is the Standardized Mini Mental State Examination (MMSE). The MMSE is designed to screen for cognitive dysfunction, assess the severity of impairments, and identify changes over time. In the country of the researchers, the Turkish adaptation of the MMSE for children has not been done and the validity and reliability of the Turkish version has not been demonstrated. This paper aims to investigate the pschiatric features of the MMSE for Turkish pediatric population.