A5009969155- Pain Mechanisms and Treatments
- Myasthenia Gravis and Thymoma
- Traffic and Road Safety
- Sleep and Work-Related Fatigue
- Vehicle emissions and performance
- Muscle Physiology and Disorders
- Fibromyalgia and Chronic Fatigue Syndrome Research
- Ion channel regulation and function
- Pain Management and Placebo Effect
- COVID-19 Clinical Research Studies
- Sleep and related disorders
- Eating Disorders and Behaviors
- Musculoskeletal pain and rehabilitation
- Forensic Toxicology and Drug Analysis
- Intensive Care Unit Cognitive Disorders
- Medical Research and Treatments
- Analytical Chemistry and Sensors
- Pediatric Pain Management Techniques
- Heart Rate Variability and Autonomic Control
- Mechanical Circulatory Support Devices
- Epilepsy research and treatment
- Parkinson's Disease and Spinal Disorders
- Respiratory Support and Mechanisms
- Cerebral Palsy and Movement Disorders
- Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Centre for Human Drug Research
2019-2025
Leiden University Medical Center
2021-2025
Leiden University
2022
The perception of pain is difficult to assess due the complex combination various components related nociception, experience, and cognition. There are currently no biomarkers affective component in healthy volunteers. Using Virtual Reality (VR), it may be possible changes when adding an painful stimulation. In this two-visit feasibility study, we effect a simulated wound VR on electrical detection (PDT) tolerance (PTT) threshold 24 male study participants. simulation presented copy research...
Abstract Dynamic balance assessments such as walking adaptability may yield a more realistic prediction of drug‐induced falls compared with postural stability measurements, often result from limited gait adjustments when walking. The Interactive Walkway (IWW) measures but sensitivity to medication effects is unknown. If proven sensitive and specific, IWW could serve biomarker for targeted fall‐risk in early clinical drug development. In this three‐way crossover study, 18 healthy elderly...
Sleep deprivation has been shown to increase pain intensity and decrease thresholds in healthy subjects. In chronic patients, sleep impairment often worsens the perceived intensity. This increased perception is result of altered nociceptive processing. We recently developed a method quantify monitor processing by simultaneous tracking psychophysical detection recording evoked cortical potentials during intra-epidermal electric stimulation. this study, we assessed sensitivity after an...
Facioscapulohumeral dystrophy (FSHD) is a progressive muscle disorder leading to significant disability. Currently, FSHD symptom severity assessed by clinical assessments such as the score and Timed Up-and-Go test. These are limited in their ability capture changes continuously full impact of disease on patients' quality life. Real-world data related physical activity, sleep, social behavior could potentially provide additional insight into might be useful assessing treatment effects aspects...
Facioscapulohumeral muscular dystrophy (FSHD) is a progressive neuromuscular disease. Its slow and variable progression makes the development of new treatments highly dependent on validated biomarkers that can quantify disease response to drug interventions.We aimed build tool estimates FSHD clinical severity based behavioral features captured using smartphone remote sensor data. The adoption monitoring tools, such as smartphones wearables, would provide novel opportunity for continuous,...
NMD670 is a first-in-class inhibitor of skeletal muscle-specific chloride channel ClC-1, developed to improve muscle weakness and fatigue in neuromuscular diseases. Preclinical studies show that ClC-1 inhibition enhances excitability, improving contractility strength. We describe the first-in-human, randomized, double-blind, placebo-controlled study, which evaluated safety, pharmacokinetics, pharmacodynamics single multiple doses healthy male female subjects. Single-ascending (50-1,600 mg)...
Measuring muscle velocity recovery cycles (MVRCs) is a method to obtain information on cell excitability, independent of neuromuscular transmission. The goal was validate MVRC as pharmacodynamic (PD) biomarker for drugs targeting excitability. As proof-of-concept, sensitivity detect effects mexiletine, voltage-gated sodium channel (Nav ) blocker, assessed. In randomized, double-blind, two-way crossover study, single pharmacologically active oral dose 333 mg mexiletine compared placebo in 15...
Abstract Drug development for mood disorders can greatly benefit from the of robust, reliable, and objective biomarkers. The incorporation smartphones wearable devices in clinical trials provide a unique opportunity to monitor behavior non-invasive manner. this study is identify correlations between remotely monitored self-reported assessments objectively measured activities with depression severity often applied trials. 30 unipolar depressed patients 29 age- gender-matched healthy controls...
Aim We assessed whether total sleep deprivation (TSD) in combination with pain tests yields a reliable method to assess altered thresholds, which subsequently may be used investigate (novel) analgesics healthy subjects. Methods This was two‐part randomized crossover study 24 men and women. Subjects were 1:1 first complete day of nonsleep‐deprived nociceptive threshold testing, followed directly by TSD night morning sleep‐deprived or the returning 7 days later for testing. A validated test...
Selective voltage-gated sodium channel blockers are of growing interest as treatment for pain. For drug development such compounds, it would be critical to have a biomarker that can used proof-of-mechanism. We aimed evaluate whether drug-induced changes in conductance detected the peripheral nerve excitability profile 18 healthy subjects. In randomized, double-blind, 3-way crossover study, effects single oral doses 333 mg mexiletine and 300 lacosamide were compared with placebo. On each...
Introduction Drivers should be aware of possible impairing effects alcohol, medicinal substance, or fatigue on driving performance. Such are assessed in clinical trials, including a task related psychomotor tasks. However, choice between predicting tasks must made. Here, we compare performance with on-the-road driving, simulator and using the effect sleep deprivation. Method This two-way cross over study included 24 healthy men minimum experience 3000km per year. Psychomotor tasks, simulated...
Abstract Introduction Daridorexant is a dual orexin receptor antagonist approved for the treatment of adult patients with insomnia disorder. Following single-dose administration at bedtime to healthy non-elderly and elderly subjects, pharmacodynamics (PD) safety were investigated in middle night (MOTN) after forced awakening noise stimulus. Methods Double-blind, placebo-controlled, randomized, 3-way crossover study (placebo, 25, 50 mg daridorexant evening) 36 male female subjects (1:1...
Background: Daridorexant is a dual orexin receptor antagonist approved for the treatment of chronic insomnia disorder. Aims: Investigate auditory awakening threshold (AAT), postural stability, and cognitive function during night following evening administration daridorexant 25 50 mg. Methods: Double-blind, placebo-controlled, randomized, 3-way (placebo, 25, mg) crossover study in 36 healthy male female nonelderly adult elderly subjects (1:1 sex/age ratio). Four hours after bedtime...
Objective Sleep deprivation is known to affect driving behavior and may lead serious car accidents similar the effects from e.g., alcohol. In a previous study, we have demonstrated that use of machine learning techniques allows adequate characterization abnormal after alprazolam and/or alcohol intake. present extend this approach sleep test model for new interventions. We aimed classify deprivation, and, by using model, tested if could also pick up resulting other interventions.Methods Data...
<sec> <title>BACKGROUND</title> Facioscapulohumeral muscular dystrophy (FSHD) is a progressive neuromuscular disease. Its slow and variable progression makes the development of new treatments highly dependent on validated biomarkers that can quantify disease response to drug interventions. </sec> <title>OBJECTIVE</title> We aimed build tool estimates FSHD clinical severity based behavioral features captured using smartphone remote sensor data. The adoption monitoring tools, such as...