Fatigue

Researchers are investigating how balance and walking abilities relate to detailed movement measurements in people with Multiple Sclerosis MS. This observational study focuses on understanding the connection between clinical tests of function and objective biomechanical data. The goal is to identify which movement characteristics best reflect balance, gait, and physical performance challenges faced by individuals with MS. Participants will attend a single laboratory session where they undergo biomechanical analysis using the Vicon motion capture system. They will complete functional assessments of balance, gait, and physical performance, as well as questionnaires about fear of falling and fatigue. Spasticity in the lower limbs will also be assessed during this visit. During the session, participants will perform tests such as the mini-BESTest for balance, Functional Gait Assessment, Short Physical Performance Battery, and a 2-minute walk test. Questionnaires like the Fall Efficacy Scale and Fatigue Severity Scale will be completed. Researchers will analyze these collected data to explore how biomechanical and functional measures relate, aiming to improve assessment tools for MS rehabilitation.

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis RA. This study focuses on understanding two main factors influencing pain relief brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinibs impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

Researchers are evaluating the potential effects of a 3-day course called the Lightning Process LP for adults with Chronic Fatigue SyndromeMyalgic Encephalomyelitis CFSME. CFSME 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 CFSME 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 CFSME 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 studying the effects of AP-Brain collagen peptide on attention, focus, stress, and memory in adults aged 35 to 70 who are stressed but otherwise healthy. The study aims to find out how different doses of AP-Brain affect brain function and to identify any side effects. The trial is a randomized, open-label, parallel design sponsored by Rousselot BVBA. Participants will take either a low dose one 1g tablet or a higher dose three 1g tablets of bovine-based AP-Brain collagen peptide once daily for 56 days. The study includes two groups receiving these different doses to compare their effects on cognitive abilities and stress levels. During the study, participants will visit the study center regularly for checkups. They will complete tests that measure attention, focus, and memory and answer surveys about stress. Blood samples will be collected, vital signs checked, and brain responses monitored to understand the impact of AP-Brain. The main outcome focuses on changes in attention and focus after 56 days of treatment.

Researchers are investigating the effects of the PAX Good Behavior Game GBG in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives Count On Me, a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions impact.

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.

This trial evaluates a behavioral sleep intervention called Care2Sleep for persons with Alzheimers disease and their caregivers. The study aims to improve sleep, health, and quality of life for both members of the dyad and to assess inflammation markers in caregivers. Participants will be randomly assigned to one of three groups in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group. The trial follows a randomized controlled design over 5 years and uses Stage II of the NIH model for behavioral intervention development. The study involves five sessions of the assigned program, whether in-person or via telehealth for Care2Sleep groups, or education-only sessions without individualized recommendations for the control group. Interventions include sleep hygiene, stimulus control, sleep compression therapy, pleasurable activities, daily walking, and light exposure for Care2Sleep participants. Sessions begin after baseline assessments and randomization. Post-treatment assessments are conducted immediately after the last session and again at 6 months. Participants will undergo baseline and follow-up evaluations including sleep efficiency measured by actigraphy and Pittsburgh Sleep Quality Index scores. Additional assessments involve cognitive and behavioral measures, quality of life scales, caregiver burden, depression scales, global health, and inflammatory markers. These evaluations occur immediately after treatment and at 6 months. The total participation duration spans from baseline through the 6-month follow-up, with careful monitoring of sleep and health outcomes for both patients and caregivers.

Road traffic accidents cause significant health problems worldwide, leading to many injuries and deaths. This research evaluates the feasibility and acceptability of Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress EMDR-IGTP-OTS to reduce post-traumatic stress symptoms, depression, and anxiety, and to improve quality of life in people who survived traffic accidents. The study uses a randomized control design involving adults aged 18 to 45 years, assessing outcomes before treatment, after treatment, and at one-month follow-up. Participants will be randomly assigned to receive either the EMDR-IGTP-OTS group therapy, which combines EMDR eight-phase protocols with the Butterfly hug technique, or to a control group with no intervention. The study evaluates how well this group therapy works and how acceptable it is for people recovering from ongoing traumatic stress due to road accidents. During the study, participants are assessed at three points using the Urdu Impact of Event Scale-Revised UIES-R, Depression Anxiety Stress Scales DASS-21, and the World Health Organization Quality of Life Questionnaire WHOQOL-BREF. The research team will monitor symptom changes and quality of life improvements over four weeks. The total study duration spans from enrollment through a one-month follow-up, aiming to support trauma-focused care in diverse and resource-limited settings.

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 TT5s 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 TT5s effects and safety.