Nottwil

Spinal cord injury (SCI) happens when the spinal cord is damaged by trauma or other causes, disrupting how sensory information travels from the body to the brain. This disruption can affect embodiment, which is the brain's processing of body awareness and physical sensations, sometimes causing disembodiment. People with SCI may experience unusual body sensations, such as feeling a limb is in a different position, which can affect daily life, mental health, and rehabilitation. The understanding of embodiment changes in SCI is limited, so this study aims to explore these changes and their impact, including brain activity measured by functional magnetic resonance imaging (fMRI). Both individuals with SCI and those without will participate. The study involves two main assessments: a detailed behavioral evaluation of embodiment and its effects on daily living, considering pain, emotions, anxiety, sleep quality, life satisfaction, and cognition; and brain imaging using MRI. The MRI procedure includes structural scans, resting-state, and task-based fMRI using a modified rubber hand illusion task. During this task, participants lie in the MRI with bent legs while viewing virtual legs being stroked on a screen, and their own leg is stroked simultaneously. They report how strongly they feel the virtual legs are their own, measuring embodiment. Participants will attend a single examination lasting 2 to 2.5 hours, including about 55 minutes inside the MRI scanner. During the visit, researchers will conduct the behavioral assessments and MRI scans. The main outcome measured is the score on the Body Feelings and Illusions questionnaire at baseline. Safety and ability to complete procedures will be monitored throughout. This study includes adults aged 18 to 60 years who meet the specific criteria for SCI or healthy controls.

Researchers are evaluating the safety and early effectiveness of ARC-IM Therapy, which uses epidural electrical stimulation, to help improve walking and other ambulatory functions in people with subacute and chronic spinal cord injury (SCI). This trial focuses on individuals with spinal cord injuries caused by trauma, including those with injuries sustained less than 6 weeks ago or more than 1 year prior. All participants will receive ARC-IM Therapy delivered by the ARC-IM Lumbar System, which sends electrical impulses to the lower spinal cord region. The treatment aims to support recovery of walking ability by stimulating the lumbosacral spinal area. The study includes people aged 18 to 65 years with various levels of SCI severity and requires ongoing adherence to the treatment and study procedures. Participants will be closely monitored for safety, including any serious or related adverse events from the time of device implantation up to 6 years. The study also involves regular evaluations of physical and psychological condition, ambulatory function, and overall health status. Follow-up assessments will help researchers understand the therapy's impact and any risks over the long term.

Researchers are evaluating how well a new skin and nasal cleaning treatment with polyhexanide works compared to the usual treatment with mupirocin and chlorhexidine to reduce the presence of Staphylococcus aureus bacteria before elective spine surgery. This pilot randomized controlled trial aims to see if the polyhexanide regimen is feasible, tolerable, and effective in lowering bacterial colonization. The study focuses on adults scheduled for elective spinal surgery who carry this bacteria without symptoms. Participants are randomly assigned to one of two groups. One group applies Prontoderm4 Nasal Gel and uses Prontoderm4 Foam for whole-body washing daily for five days before surgery. The other group applies Bactroban4 Nasal ointment and washes with Lifo-Scrub4 daily for five days before surgery. These treatments are provided in the preoperative phase to compare their impact on bacterial reduction. During the study, researchers monitor how many participants are successfully randomized, as well as other feasibility and tolerability outcomes. They measure the decrease in bacterial colony-forming units and changes in the nasal and skin microbiome. These assessments help determine the potential of the new treatment. The average study duration is about two years, focusing on pre-surgery preparation and bacterial decolonization effectiveness.

Researchers are studying how voltage gated sodium channels called NaV1.7 contribute to pain in people with neuropathic pain and chronic pain after surgery. The goal is to understand pain mechanisms better by examining how these channels affect nerve responses and pain sensations in affected skin areas. The study involves using slow, sinus-like electrical stimulation of the skin to activate unmyelinated nerve fibers that may involve NaV1.7 channels. This electrical stimulation may cause pain even at low currents in patients, unlike in healthy individuals. The study also uses laser-evoked potentials and sensory testing to characterize pain around surgical scars. Pain questionnaires will be collected to assess participants' pain experiences. Participants will undergo electrophysiological tests of their peripheral nerves while researchers measure changes in pain intensity during the electrical stimulation. The study will evaluate how the nerves respond and how this relates to pain levels. This approach aims to improve understanding of pain mechanisms and potentially predict responses to treatments like lidocaine patches. Participants will be monitored closely throughout the assessments.

Researchers are investigating the effects of combining a powered exoskeleton with functional electrical stimulation (FES) for people with chronic spinal cord injury (SCI). SCI can cause loss of motor, sensory, and vegetative functions, making recovery of walking, balance, and mobility important goals. While powered exoskeletons and FES have both shown benefits in improving walking and secondary health issues, no well-designed randomized trials have compared the combined approach to exoskeleton therapy alone. Participants will receive treatment using the EksoNR powered exoskeleton, a wearable robotic device that supports standing and walking over ground. One group will receive therapy combining this exoskeleton with FES delivered by the RehaMove2 device, which uses electrical impulses to stimulate muscles. The hybrid approach aims to reduce muscle fatigue and enhance mobility by supplementing muscle power with motorized assistance. The study compares this combined therapy to exoskeleton use alone. During the study, participants' preferred walking speed will be measured before and after training using a 10-meter walk test. Researchers will assess improvements in walking function and monitor secondary health parameters. The study includes participants with chronic, incomplete SCI who can stand and walk with or without aids. Safety and effectiveness will be evaluated shortly after the intervention to determine the potential benefits of this combined therapy.

Researchers are comparing two types of functional electrical stimulation (FES) leg exercises in people with spinal cord injury (SCI) to evaluate their effects on leg aerobic fitness and leg strength. This study involves adults aged 18 to 75 years with motor complete SCI between vertebrae C7 and T10 who are more than six weeks post-injury. The goal is to determine which FES training approach is more effective for improving fitness and strength in this population. Participants are randomly assigned to one of two groups: the high-intensity short duration group (HI-SHORT) or the low-intensity long duration group (LO-LONG). Both groups will perform FES-evoked leg exercises using the Hasomed RehaStim exercise ergometer three to four times a week for 6 to 8 weeks, completing 24 therapy sessions. The HI-SHORT group does 10 intervals of 2 minutes each with rest periods in between, while the LO-LONG group performs 20 to 40 minutes of continuous exercise at a lower intensity. Exercise intensity is adjusted individually based on neuromuscular stimulation. Participants will be assessed before starting training and after 6 to 8 weeks of therapy. The main outcome being measured is aerobic fitness of the legs induced by FES. During the study, participants will need to follow instructions and perform exercises regularly. Safety measures exclude individuals with certain health issues that could interfere with exercise. This trial aims to help improve rehabilitation methods for people with spinal cord injuries.

This clinical trial investigates NG004, a human monoclonal antibody, in patients with acute incomplete cervical spinal cord injury (SCI). The study aims to assess the safety, tolerability, and pharmacokinetics of four different dose regimens of NG004. It is a first-in-human, multicenter, open-label, sequential, multiple ascending dose Phase 1 trial designed to find the maximum tolerated dose of NG004 in this patient group. Participants will receive repeated intrathecal injections of NG004, meaning the drug is administered directly into the spinal canal. The study evaluates four escalating dose levels to understand how the body processes the drug and to monitor for any side effects or adverse reactions. There is no placebo or comparator group; all participants receive the investigational treatment. Throughout the treatment period and up to six months afterward, participants will be closely monitored for any adverse events, including their type, frequency, severity, and relationship to the drug. The study includes regular clinical assessments to ensure patient stability and safety. Total participation duration includes treatment and follow-up for safety evaluation.

This research aims to evaluate the management and outcomes of tracheostomy removal in patients hospitalized at the Swiss Paraplegic Centre Nottwil. It focuses on understanding the rates of physical complications, such as those requiring treatment, reintubation, recannulation, or resulting in death, over a period of three months following the removal of the tracheal cannula. The study also seeks to describe the types of complications occurring shortly after and up to three months post-decannulation, identify predictors for these complications, explore patient perspectives, and assess individual clinical decannulation protocols. Participants are adult patients who have had a tracheostomy and were hospitalized at the Swiss Paraplegic Centre Nottwil during the data collection period. The study follows patients from the time of decannulation and observes their outcomes over three months. There are no experimental treatments or interventions being tested, as this is an observational study focused on monitoring and documenting patient outcomes after decannulation. During the study, researchers will monitor participants at multiple time points: 4 days, 1 month, and 3 months after decannulation. They will track the rate of physical complications, reintubation, recannulation, and mortality. The study also involves collecting patient feedback on their experiences with decannulation and analyzing clinical protocols to understand individual patient trajectories. Participants will be assessed through medical records and possibly interviews during the three months following decannulation.

Researchers are evaluating the effects of robot-assisted therapy using the ArmeoSpring compared to conventional occupational therapy on upper limb function in individuals with cervical spinal cord injury (cSCI). The study focuses on which therapy better improves arm and hand function. It is designed as a cross-over trial where each participant receives both types of therapy in random order, during their primary rehabilitation period between 16 and 81 days post-injury. Participants receive two therapy forms consecutively: unilateral robot-assisted therapy (RT) and unilateral conventional occupational therapy (OT). Each therapy is administered as an add-on to routine care for 6 weeks, with sessions three times a week lasting 30 minutes each. The RT uses the ArmeoSpring, a spring-based arm orthosis providing adjustable antigravity support, while OT includes strengthening, grasping, fine motor training, and activity-based tasks performed with one arm. Throughout the study, participants complete a baseline assessment, an intermediate assessment after the first therapy period, a post assessment after the second therapy period, and a follow-up assessment if within 150 days post-injury. Researchers measure grasp performance at these time points to evaluate improvements in upper limb function. The study also monitors safety and therapy adherence during the trial.

Researchers are evaluating the safety and feasibility of two versions of the TWIICE Rise, a robotic exoskeleton designed to assist walking in patients with spinal cord injuries. The study is conducted in two phases, initially testing TWIICE Rise 0.0 with five patients over six clinic sessions to gather data for device improvement. The second phase involves TWIICE Rise 1.0, which has enhanced features based on feedback, and includes ten patients undergoing ten sessions in various settings such as clinics, homes, and community environments. The TWIICE Rise exoskeleton supports lower-limb movement and is intended for use under supervision by a specially trained coach in rehabilitation centers, homes, or community settings. During phase two, participants first train in a rehabilitation center to learn walking with the exoskeleton. After demonstrating sufficient walking skills through mobility tests, they continue sessions at home and in community locations to test the device in real-life conditions. Participants will be monitored throughout the study with a focus on the incidence of serious adverse device effects and device deficiencies from enrollment until the end of the 10-week intervention. Safety and functional assessments will occur across the sessions, and patients' ability to use the device in different environments will be evaluated. The total participation duration covers the full intervention period, with close observation to ensure safety and study feasibility.