Telese

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are studying how the autonomic nervous system is involved in patients with relapsing-remitting and primary progressive multiple sclerosis. The study aims to understand if characteristics of autonomic dysfunction can help improve treatment for symptoms like blood pressure changes and temperature control issues that affect patients lives and rehabilitation. It also explores how nerve fiber impairments relate to disease severity and progression, and whether different types of multiple sclerosis show distinct patterns of nerve involvement. Participants will be hospitalized at the Maugeri Clinical Institute of Telese Terme for rehabilitation treatment. They will undergo tests including cardiovascular reflex testing and a skin biopsy to measure sensory and autonomic nerve fibers. Clinical scales assessing autonomic symptoms and pain related to small fiber neuropathy will also be used. The study compares findings between relapsing-remitting and primary progressive multiple sclerosis groups, as well as with control data. During the study, participants will have cardiovascular reflex and sudomotor function tests at recruitment. Skin biopsies will quantify peripheral nerve fibers, and patients will complete questionnaires about their symptoms. Researchers will monitor nerve function and symptom severity to better understand autonomic involvement in multiple sclerosis. The trial began in 2021 and is expected to end in 2027, with no specified maximum age for participation.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Researchers are evaluating whether a high-tech rehabilitation circuit is more effective than traditional rehabilitation methods for improving function, especially balance control, in patients with acute neuromuscular diseases NMDs. The study focuses on conditions such as Guillain-Barre9 Syndrome GBS, Critical Illness Myopathy CIM, and Critical Illness Polyneuropathy CIP, aiming to improve motor function, fatigue, muscle loss, cognitive engagement, and overall quality of life. The study compares two groups one receiving high-tech rehabilitation using robotic verticalization systems, virtual reality devices, stabilometric platforms, and robotic treadmills, and a control group receiving standard rehabilitation care. The high-tech group is further divided into three phases based on balance ability measured by the Berg Balance Scale, with treatments tailored accordingly. The intervention lasts up to 60 days. Participants will undergo assessments of balance, motor function, walking ability, muscle strength, fatigue, and quality of life at multiple time points during the 60-day treatment period. Researchers will measure changes in balance using the Berg Balance Scale as the primary outcome. Secondary outcomes include functional independence, trunk control, walking tests, and patient perception of the rehabilitation technology. Safety and adherence will also be monitored throughout the study.

This research aims to evaluate whether a rehabilitation program that uses advanced technologies like robotic systems, virtual reality, and stabilometric platforms is not worse than traditional rehabilitation in reducing fatigue and improving balance, motor skills, and quality of life in adults with chronic neuromuscular diseases such as ALS, CIDP, and Charcot-Marie-Tooth disease. The study is designed as an interventional, randomized, double-blind trial to compare these two rehabilitation approaches. Participants will be assigned to one of two groups the robotic treatment group or the control group. The robotic group will engage in motor and cognitive exercises using devices such as VRRS EVO for virtual reality, GEA MASTER or PROKIN Technobody platforms for balance training, and Walkerview Technobody robotic treadmills for aerobic exercises, combined with usual physiotherapy. The control group will receive traditional rehabilitation treatments as per standard clinical practice. Treatment effects will be measured over a 60-day period. During the study, participants will undergo various assessments including fatigue severity, walking and mobility tests, quality of life surveys, patient perception questionnaires, and disease-specific functional rating scales at multiple time points from baseline to day 60. Researchers will monitor changes in these measures to determine the impact of the high-tech rehabilitation compared to traditional methods. The total participation time includes multiple visits and evaluations during the study timeline ending in March 2026.

Researchers are studying patients with amyotrophic lateral sclerosis ALS within 18 months of their first motor symptoms to understand how the autonomic and sensory nervous systems change as the disease progresses. The study aims to find out if early autonomic dysfunction relates to disease progression and survival, and whether skin biomarkers can help track the disease and evaluate future treatments. Healthy people matched by age and sex will be included for comparison. Participants include ALS patients and healthy controls. ALS patients will undergo clinical exams, questionnaires on symptoms, quality of life, pain, and neuropsychological tests. They will also have genetic screening and tests of the autonomic nervous system, including skin biopsies and cardiovascular reflex testing. Follow-up assessments, including skin biopsies and clinical scales, will be done about six months later to monitor changes. During the study, researchers will collect blood samples, conduct skin biopsies to study nerve fibers, and perform cardiovascular and sweat function tests. Questionnaires and clinical scales will help evaluate symptoms and quality of life. The main outcomes measured are the sensory and autonomic nerve innervation at recruitment and follow-up. This study will last until December 2026 and includes ongoing monitoring of participants disease progression and nervous system involvement.

Researchers are examining how different types of pain and autonomic symptoms affect people diagnosed with Parkinsons disease PD and multiple system atrophy MSA receiving care at Maugeri Clinical Scientific Institutes. The study aims to evaluate the prevalence and characteristics of pain and autonomic dysfunction, assess how rehabilitation impacts these symptoms, and understand their effect on quality of life for both inpatients and outpatients. All participants will receive a neurological exam and participate in a rehabilitation program designed to improve strength, coordination, balance, endurance, and daily living skills. Clinical scales will be used to assess disease stage, severity, motor and non-motor symptoms, cognitive function, depression, autonomic dysfunction, pain, and quality of life. The study compares patients with PD and MSA and measures outcomes before and after an average 30-day rehabilitation period. Participants will undergo evaluations at recruitment and after completing rehabilitation, including assessments of pain and autonomic symptoms. Researchers will monitor changes in clinical scores and quality of life throughout the study. This observational study will provide insights to help clinicians better manage disability and tailor rehabilitation strategies to improve patients well-being over the course of their care.

Researchers are evaluating the effects of prismatic adaptation combined with serious games on cognitive and behavioral deficits in patients who have experienced traumatic brain injury TBI. This study compares a novel rehabilitation protocol using prismatic lenses and serious games to a control rehabilitation training that uses serious games without prismatic adaptation. The goal is to assess how this new approach impacts cognitive outcomes and brain activity patterns measured by EEG. Participants will be randomly assigned to one of two groups. The experimental group will undergo prismatic adaptation sessions where they wear prismatic lenses and perform pointing exercises on a tablet, followed by cognitive training using serious games. This occurs over 10 days across two weeks, with 40-minute sessions each day. The control group will receive the same serious games without the prismatic adaptation. Both groups also receive standard cognitive rehabilitation using paper and pen exercises. Each rehabilitation session lasts about one hour, five days per week for two weeks. During the study, participants will be assessed at the start and after completing the 10 rehabilitation sessions to measure changes in cognitive and behavioral function. Assessments include neuropsychological tests and EEG recordings. After the study period, all patients will continue with standard cognitive and motor rehabilitation. The total participation time includes the initial treatment phase and follow-up assessments, with the study concluding upon discharge from the rehabilitation unit.

Researchers are studying the effects of adding music to rehabilitation training for patients with Chronic Obstructive Pulmonary Disease COPD and chronic respiratory failure CRF. This trial compares usual rehabilitation training to training supported by music, aiming to see if music can improve exercise capacity, endurance, and reduce fatigue and breathlessness. Previous studies suggest music may help reduce symptoms like anxiety and dyspnea and improve quality of life for COPD patients during exercise. Participants will be randomly assigned to one of two groups a music-supported training group or a usual training group without music. The music group listens to selected music styles with a constant rhythm designed to synchronize with cycling exercise sessions lasting about 30 minutes. Both groups perform supervised training on a cycle ergometer, with the only difference being the presence or absence of music. Training occurs 5 to 6 times per week over 12 to 14 sessions. Throughout the study, participants will undergo various assessments including lung function tests, 6-minute walk tests, muscle strength measurements, blood gas analysis, and exercise endurance tests. Heart rate, oxygen saturation, and breathlessness levels will be monitored before and after each session. The primary outcome is the change in walking test performance after up to three weeks of training, with additional evaluations of breathlessness, fatigue, and disease impact on daily activities. Safety, adherence, and reasons for withdrawal will also be tracked by the study team.