Spinal Cord Injury

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 effectiveness and safety of Recombinant Botulinum Toxin Type A (YY001) injections for treating upper limb spasticity in adults who have had a stroke. This randomized, double-blind, multi-center phase II/III study compares YY001 with BOTOX4 and a placebo to better understand treatment options for this condition. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) with a dose of 200-400 units, BOTOX4 with a dose of 200 units, or a placebo prepared with saline. The study includes three groups: the experimental group receiving YY001, an active-controlled group receiving BOTOX4, and a placebo-controlled group. Each participant receives only one injection during the treatment period. During the study, participants will be monitored at 1, 4, 8, and 12 weeks after treatment through assessments such as the Modified Ashworth Scale (MAS) for spasticity, Physician's Global Assessment, and Disability Assessment Scale (DAS). Researchers will also track any adverse events and the presence of antibodies to the treatment. The primary outcome is the change in MAS score at week 4. The study lasts at least 12 weeks with ongoing safety and efficacy follow-up.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Spinal cord injury (SCI) occurs when trauma or other factors damage the spinal cord, disrupting communication between the body and brain. This can lead to changes in body awareness called disembodiment, where sensations feel different or limbs seem out of place. The study aims to explore how SCI affects embodiment, its impact on daily life, and the related brain activity using functional magnetic resonance imaging (fMRI). Both individuals with SCI and healthy participants will take part in this research. Participants will be divided into groups: some with SCI will undergo a detailed behavioral assessment of embodiment and sensory-motor symptoms, while others will also have brain activity measured through fMRI during a task involving a modified rubber hand illusion. Healthy controls will perform similar behavioral assessments, with some also undergoing fMRI. The fMRI task includes watching virtual legs being touched while their own legs are stroked to assess the feeling of embodiment. Each participant will attend one examination lasting about 2 to 2.5 hours, including approximately 55 minutes inside the MRI scanner. Researchers will evaluate responses to questionnaires measuring body feelings, pain, emotions, cognition, and daily functioning. Brain activity and embodiment strength will also be assessed. The study will monitor various physical, psychological, and quality of life aspects to understand how SCI changes body awareness.

Researchers are evaluating the effectiveness of a smart upper limb rehabilitation system combined with exoskeleton robot devices and an Internet of Things (IoT) application for home-based training in patients recovering from stroke and those with spinal cord injuries. The study aims to improve motor function, daily living activities, and quality of life by remotely monitoring rehabilitation progress and assisting patient movements. Participants are adults aged 20 to 79 years with specific cognitive and physical criteria depending on their condition. Participants are randomly assigned to one of two groups: the TIGER group, which uses a tenodesis-induced-grip exoskeleton robot system, or the TOT group, which receives task-oriented training. Each group follows a home-based training program for 4 weeks. For stroke patients, training is 30 minutes twice daily, 5 days a week; for spinal cord injury patients, training is 40 minutes once daily, 5 days a week. The TIGER system offers passive range of motion warm-up and functional training, while the TOT group practices sensorimotor techniques and functional tasks. Participants will undergo assessments before and after the intervention, including motor function tests like the Fugl-Meyer Assessment and Box and Block Test, range of motion measurements, and quality of life evaluations. Researchers will monitor progress in motor activity, independence, and satisfaction with assistive technology. The total study duration spans from baseline through 4 weeks of training, with outcome measures collected at baseline and after the intervention period.

Researchers are studying brain activation patterns in stroke patients during mirror movement to understand upper limb function. This observational study focuses on patients who have had their first stroke, either cerebral infarction or cerebral hemorrhage, with specific muscle strength and muscle tone conditions. The study takes place in a hospital rehabilitation ward where patients receive detailed information and provide informed consent before participation. The study involves two types of hand movements: mirror image and healthy hand movement. In the mirror image intervention, patients place their affected hand in a mirror box and observe the reflection of the healthy hand moving, imagining the affected hand performing the same actions. In the healthy hand movement intervention, patients quickly open and grasp their healthy hand while focusing on the affected hand. The primary outcome is brain activation measured by functional near-infrared spectroscopy (fNIRS) after one week of hand function rehabilitation training. Participants will be closely monitored throughout the trial with full communication and support from the research team. The study involves observing brain activation and hand movement activity with attention to patients' questions and responses. The total participation period includes the initial week of rehabilitation training followed by assessments to measure the brain's response to the interventions.

Researchers are evaluating a low-cost augmented reality platform for balance training in patients with balance disorders caused by degenerative injuries or cerebrovascular diseases. The study aims to determine if the system is usable, acceptable, safe, and if it improves balance. The trial is a usability study conducted by the Hospital Universitari Vall d'Hebron Research Institute. The intervention has two phases: the first phase lasts four weeks with supervised balance training sessions at the hospital, conducted for 60 minutes, three times a week. If patients meet inclusion criteria, the intervention continues for two additional weeks at home with a family member trained to assist as a training partner. The platform uses different exercise protocols accessed through RGSweb, including balance and sit-to-stand exercises with visual targets and movement tracking. Participants undergo three assessments: before treatment (Day 0), after the hospital phase (Week 4), and after the home phase (Week 6). Evaluations include usability scales, adherence measures, balance tests like the Berg Balance Scale, postural sway, sit-to-stand tests, balance confidence, and quality of life questionnaires. Safety is monitored throughout, and adherence is tracked during both hospital and home interventions.

Researchers are studying a surgically implanted functional electrical stimulation (FES) system designed to improve stability of the trunk and hips in people with spinal cord injuries, paralysis, tetraplegia, or paraplegia. This system uses small electric currents to make muscles contract, aiming to help users sit more steadily, breathe better, reach farther, push a wheelchair, or roll in bed. The study is conducted by the VA Office of Research and Development and focuses on how this neuroprosthesis affects posture and mobility. The study involves one surgical procedure to implant electrodes into the trunk and hip muscles. These electrodes connect to an 8-channel stimulator implanted in the abdomen. After surgery, participants spend two to six weeks at home with limited activity to allow healing. Following this, they undergo exercise and training to begin using the neuroprosthesis functionally. Participants will be assessed in the lab for strength, balance, and functional abilities both with and without the system, while the implanted device’s technical performance is also monitored. Participants will be involved for up to 36 months, during which researchers will measure the effects of trunk stimulation on posture control, breathing, pressure distribution while seated, reach ability, stability, and personal mobility. They will also work on designing a simple position controller. The study includes post-operative training and follow-up visits to track progress, device function, and safety over time.

Researchers are exploring the effects of different types of stimulation—magnetic stimulation to activate the brain, electrical spinal cord stimulation, and electrical muscle stimulation—on people with spinal cord injury (SCI) and able-bodied individuals. The study focuses on activating muscles in the arms, legs, and trunk to understand how these stimulations impact neuromotor function in these groups. Participants will receive interventions including intermittent theta burst stimulation (iTBS), functional electrical stimulation (FES), and transcutaneous spinal cord stimulation (TSCS). Each treatment uses devices that apply magnetic or electrical pulses to activate specific brain regions, spinal cord areas, or muscles. There is also a sham iTBS group where a magnetic coil is placed but no stimulation is given. Each participant will attend at least 9 sessions over two months, with each visit lasting about 2 to 3 hours. Participants are grouped based on their injury status and ambulatory ability. During the study, participants will undergo assessments including the nine-hole peg test, foot tapping test, Function in Sitting Test for people with SCI, and Motor Evoked Potential measurements. These tests will be conducted at the start and throughout the two-month period to monitor changes. The study will evaluate how the different stimulations affect motor function and neuromuscular responses over time.

Researchers are evaluating whether a cognitive training program can improve processing speed in individuals who have recently experienced an acute traumatic spinal cord injury (SCI). This pilot randomized controlled trial aims to address cognitive difficulties such as attention, memory, and information processing speed, which can significantly impact rehabilitation outcomes and quality of life. The study focuses on early intervention to potentially enhance overall health and well-being for people with acute SCI. Participants are randomly assigned to one of two groups: an experimental group or a placebo control group. Both groups complete pre-specified game-like computerized tasks using an internet-based cognitive training portal. These sessions occur three times per week, lasting 60 minutes each, over a total of 12 weeks. The study uses a quadruple masking design to reduce bias. During the study, participants undergo assessments at baseline, immediately after treatment (week 13), and at long-term follow-up (week 25). Researchers measure processing speed using tests such as the Useful Field of View (UFOV), Letter & Pattern Comparison (LPC), and Symbol Digit Modalities Test (SDMT). Quality of life related to spinal cord injury is also evaluated. The total participation period spans approximately six months, including treatment and follow-up evaluations.