Fibromyalgia

Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

Researchers are evaluating the potential effects of a 3-day course called the Lightning Process (LP) for adults with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). CFS/ME is a serious condition causing heavy symptoms, low function, and significant impact on work and social life. The study aims to explore both positive and negative effects on symptoms, disability, quality of life, and long-term work participation, addressing a challenging health and societal problem in Norway. The study randomly assigns about 100 adults with CFS/ME to either participate in the 3-day LP course or receive treatment as usual initially. The LP course includes teaching on stress theory, Positive Psychology, and techniques to regulate thoughts, feelings, and behavior to influence physiology positively. Those initially on the waiting list receive the LP course after 10 weeks. Adverse events during or after the course are monitored and managed according to protocol. Participants will be followed up with assessments including physical function at 10 weeks after the course and fatigue, pain, post-exertional malaise, mental wellbeing, overall improvement at 6 months. Work participation and sick leave are tracked at 24 months. The study involves questionnaires and evaluations to measure these outcomes, aiming to provide evidence-based knowledge for better CFS/ME care. The study runs until December 2028.

Researchers are evaluating the analgesic effect and safety of a mixed reality (MR) based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups: the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale (VAS) to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.

Researchers are investigating treatments for temporomandibular disorders (TMD), which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups: one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.

Researchers are conducting a first-in-human, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 given at different doses in healthy volunteers and surgical patients. This phase 1 trial includes both single and multiple ascending dose parts and involves healthy and surgical participants aged 18 to 55 years. The study aims to explore TT5's effects, including psychological responses and potential fluid biomarkers. The study consists of three parts: Part A tests single ascending intravenous doses of TT5 in healthy participants across up to five dose levels; Part B evaluates multiple ascending doses over seven days in healthy participants with up to three dose levels; and Part C administers intravenous doses on the same day to surgical patients in up to three dose levels. Both TT5 and placebo (vehicle) are given intravenously, and dosing schedules vary according to the study part. Participants will be monitored for adverse events, vital signs, physical exams, laboratory tests, and psychological responses using tools like the Bond and Lader Visual Analog Scale. Pharmacokinetic measurements will include plasma and urine analysis over specified days. Safety and tolerability will be assessed through day 8 for single doses and day 14 for multiple doses. The total study duration varies by cohort, with close follow-up during and after dosing to evaluate TT5's effects and safety.

Researchers are studying whether the handheld device called Grasp can help reduce pain and distress in children and adolescents aged 8 to 15 during small needle procedures. These procedures include venous puncture, insertion of a peripheral venous catheter, and local anesthesia injections before dental treatment. The study aims to compare the effects of using Grasp during these procedures with standard care to see if it helps improve the experience for young patients. Grasp is a soft silicone ball with pressure sensors that detect squeezes of different strengths and durations. When squeezed, it provides real-time visual and auditory feedback through an iPad application, playing melodies and showing dynamic curves. Participants in the intervention group will squeeze the Grasp ball repeatedly, starting at least 10 seconds before and continuing throughout the needle procedure. The control group will receive standard care without Grasp. In addition to the randomized trial, six children with type 1 diabetes will use Grasp during blood sugar measurements or insulin injections as part of exploratory use. During the study, participants will fill out questionnaires about their pain and distress before and after the procedure, as will their parents or guardians. Some participants at the dental clinic will use Grasp during further dental treatment and complete additional forms afterward. The main measure is self-reported pain immediately after the procedure, with secondary measures including distress reported by both children and parents. The study includes interviews with some participants to explore their experiences, and statistical analyses will assess the impact of using Grasp.

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

Researchers are conducting a multi-center clinical longitudinal study to better understand neuropathic pain by examining patients' brain activity and cognitive function. The study collects detailed data on pain levels, sleep quality, social support, anxiety, depression, and cognitive tasks using various scales and imaging techniques. This observational research aims to track changes in these factors during acute pain episodes in adults aged 18 to 85 years. Participants diagnosed with neuropathic pain will join the study and receive standard care from the pain department while being observed over time. The study includes evaluations using pain scales like the Visual Analogue Scale (VAS) and digital pain grading (NRS), as well as assessments of sleep, anxiety, cognitive function, and brain activity through electroencephalogram (EEG) and near-infrared brain imaging (fNIRS). Follow-up continues up to three months after enrollment to monitor changes. During the study, participants will undergo various assessments including pain scoring, cognitive tests, emotional tasks, and questionnaires on sleep and social support. Brain function will be monitored using EEG and fNIRS. Researchers will evaluate measures such as pain intensity, sleep quality, anxiety and depression levels, and cognitive abilities at one month. Participants' progress will be closely observed throughout the study period, which lasts at least three months post-enrollment.

Childhood obesity is a growing public health issue worldwide and especially in Spain, where it is more prevalent in southern regions. Factors contributing to this include dietary habits, physical inactivity, socioeconomic status, and family environment. The study aims to evaluate the impact of a nutritional intervention administered by school nurses to address childhood obesity and its health consequences, including heart and musculoskeletal issues. The study compares two groups of schoolchildren aged 6 to 16. One group receives a technological intervention using podcasts, gamification, and virtual reality to promote nutrition education and healthy behaviors. The control group receives traditional brochures with nutritional information. Both groups are monitored through various measurements and biometric data collected over a 15-month period. Participants will be assessed regularly for weight, height, body composition, circumference measures, blood pressure, and adherence to the Mediterranean diet using questionnaires. Additional evaluations include a 3D avatar system for anthropometric measures. The study includes data collection at multiple timepoints from 12 weeks up to 15 months, with ongoing monitoring to assess the effectiveness of the intervention and potential health improvements.