Paralysis

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use. Participants will: * Wear a sensor that records everyday activities and mobility. * Perform measures of mobility and different activities of participation using their own brace. * Perform measures of mobility and different activities of participation using the Nomad powered KAFO

Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. One of the most serious consequences is motor paralysis caused by metastatic epidural spinal cord compression (MESCC), which can severely impair patients' quality of life and limit their ability to receive subsequent anti-tumor therapy. Although surgical decompression and stabilization are recognized as effective strategies for relieving spinal cord compression and restoring spinal integrity, the neurological prognosis for patients who present with paralysis remains uncertain and heterogeneous. This prospective, single-center, observational cohort study aims to evaluate the early and mid-term neurological recovery trajectories in patients with paralysis caused by spinal metastases, and to identify perioperative clinical factors associated with favorable or poor functional outcomes. The study will be conducted at Shanghai Changzheng Hospital, a tertiary care academic center with extensive experience in spinal oncology and multidisciplinary cancer care. The investigators plan to consecutively enroll adult patients (aged 18-80) diagnosed with spinal metastatic tumors who present with motor paralysis and are deemed appropriate surgical candidates by a multidisciplinary tumor board. Participants will undergo surgical decompression and stabilization based on individualized tumor location and spinal instability. The study does not involve any investigational drug or device. All surgical procedures and adjuvant treatments (such as radiotherapy or systemic therapy) will be delivered according to standard of care. Preoperative evaluations will include spinal imaging (MRI, CT), neurological scoring using the ASIA Impairment Scale, and assessments of systemic condition, spinal instability (SINS), and epidural compression severity (ESCC scale). Participants will be followed at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery to monitor neurological recovery, pain control, bowel/bladder function, treatment complications, and survival. The primary outcome is the improvement in motor function at 1 month postoperatively, quantified by changes in ASIA motor scores. Secondary outcomes include longer-term neurological recovery, progression of bowel and bladder function, quality of life, complication rates, disease progression, and survival outcomes. Additional analyses will explore the impact of variables such as timing of surgery, tumor histology, location of compression, and performance status on recovery. This study will employ both univariate and multivariate statistical methods to identify independent predictors of postoperative neurological improvement, using logistic regression and time-to-event analyses. A total of 150 participants will be recruited, based on power analysis accounting for key covariates and anticipated dropout rates. Through this prospective clinical registry and analysis, the study aims to provide evidence-based data to guide clinical decision-making in the management of MESCC with paralysis. The findings will help inform surgical indications, optimize timing of intervention, and support the development of prognostic tools for patient counseling. Given the limited life expectancy of many patients with advanced cancer, maximizing early neurological recovery may directly impact patient autonomy, eligibility for systemic therapy, and overall quality of life.

This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries. In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities. During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors. The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.