Paralysis

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.

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 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 the StrokeWear system to see how it affects clinical outcomes in people who have recently experienced a stroke. This study is a two-arm randomized clinical trial focusing on subacute stroke survivors with hemiparetic upper extremity weakness. The goal is to understand whether using the StrokeWear system combined with a motor and behavioral home intervention improves arm use compared to usual care involving a home exercise plan. Participants in the intervention group will use the StrokeWear system along with behavioral strategies designed to encourage arm use through feedback, goal setting, and daily activity planning over 6 months. They will receive weekly coaching sessions in the first month, bi-weekly in months two and three, and monthly sessions in months four to six, which can be in-person or remote. The control group will receive usual care, including standard rehabilitation and a home exercise plan, with monthly visits to update their exercises. Study participants will attend four evaluation visits: screening and enrollment, baseline, 3 months, and at the study's 6-month completion. Researchers will assess upper-extremity motor function using multiple scales such as the Motor Activity Log and Fugl-Meyer Assessment. Additional tests include the Wolf Motor Function Test and Stroke Impact Scale. Monitoring includes assessing changes in arm use, motor function, and self-efficacy. The total participation lasts for six months, with assessments at regular intervals to track progress and outcomes.

This research aims to evaluate the immune response, safety, and consistency between different batches of the LBVD vaccine compared to the combined use of Pentavalent and Inactivated Poliomyelitis vaccines in healthy infants aged 6 to 8 weeks. The study is divided into two stages: Stage 1 compares LBVD with licensed control vaccines, and Stage 2 confirms that LBVD is not inferior to control vaccines and assesses consistency across three lots of LBVD. Participants receive a three-dose primary vaccination series at 6, 10, and 14 weeks of age. The LBVD vaccine is administered as an intramuscular injection into the thigh. The control group receives co-administration of Pentavalent and Inactivated Polio vaccines. Stage 1 focuses on initial comparisons, while Stage 2 includes multiple LBVD lots to evaluate lot-to-lot consistency. Throughout the study, infants will be monitored for immune protection levels and antibody concentrations four weeks after completing the vaccination series. Safety is tracked by observing immediate reactions within 30 minutes, solicited side effects within 7 days, and other adverse events within 4 weeks post-vaccination. The study follows infants from 6 weeks through 8 weeks of age, including all vaccine administrations and safety assessments.

Researchers are evaluating the safety and immune response of a new vaccine called VLP-Polio in healthy infants and toddlers. This phase I/II study is randomized, double-blind, and controlled, aiming to explore different dosing levels of the vaccine compared to a control vaccine. The trial focuses on infants starting from 6 weeks old up to toddlers aged 12 to 18 months who have already received their primary polio immunization. Participants in the toddler group will receive a single dose of either a high dose of VLP-Polio or a control vaccine. Infants will be randomly assigned to one of four groups receiving either a low-adjuvant, medium, or high dose of VLP-Polio or a control vaccine. Infants will get three doses spaced 28 days apart, plus a booster dose between 12 to 18 months of age. The study enrolls participants in descending age groups and ascending dosing levels. Throughout the study, blood and mucosal samples will be collected to evaluate immune responses. Researchers will monitor for side effects within 7 days after each vaccination and track any serious adverse events throughout the trial. The main outcomes include measuring antibodies against different types of poliovirus before vaccination and after the third dose. The total participation duration varies by age group but includes follow-up periods up to about 20 to 22 months of age.

Researchers are evaluating the safety and usefulness of a new delivery device designed to inject LCTOPC1, a cell therapy, into the spinal cord of people with spinal cord injuries (SCI). LCTOPC1 aims to replace or support cells lost or damaged due to trauma, with the goal of improving quality of life and helping restore or enhance function in individuals with cervical or thoracic SCI. This Phase 1b, open-label, multi-center study focuses on both subacute and chronic SCI patients with specific injury types and locations. The study involves a one-time injection of 10 million LCTOPC1 cells administered via the novel delivery device directly to the injured spinal cord tissue. Participants include those with subacute injuries occurring 21 to 42 days before treatment and those with chronic injuries from 1 to 5 years prior. The first four participants will be enrolled sequentially after safety criteria are met. The injection is given during an elective surgical procedure, and the study monitors safety over a long-term period. Participants will undergo close monitoring for safety, including assessments of adverse events related to the device and injection procedure up to 30 days, and additional evaluations of adverse events related to LCTOPC1 and immunosuppression up to 90 days. MRI scans will assess any changes in spinal cord condition at 90 days. The study plans to follow participants for up to 10 years after treatment to track long-term safety and outcomes.

Researchers are investigating the use of vagus nerve stimulation (VNS) combined with rehabilitation to improve arm movement after an ischemic stroke. This clinical trial compares active VNS paired with rehabilitation against a sham VNS with no electrical stimulation, also combined with rehabilitation, to assess their effects on upper extremity motor function in stroke patients. The study is conducted with a triple-blind, randomized, sham-controlled design and aims to evaluate both safety and efficacy.

This trial studies adults aged 18 to 70 with recent spinal cord injuries to compare a new robotic wearable exoskeleton for walking rehabilitation against conventional therapy. It aims to find out if robotic therapy improves walking ability and reduces healthcare and caregiver burden and costs more effectively than standard care within the Spanish Healthcare System. Participants will be randomly assigned to receive either the ABLE Exoskeleton or conventional therapy involving joint mobilization, muscle strengthening, and walking re-education with aids. Both groups undergo 24 rehabilitation sessions, three times a week, over 8 weeks. Assessments take place before, during, and after treatment, with a follow-up 2 months later. During the study, participants will have clinical, functional, physiological, psychological, and socioeconomic evaluations including walking ability, balance, motor scores, endurance, bladder/bowel function, pain, spasticity, and quality of life. Caregiver burden and healthcare costs are also measured. Safety and progress are monitored at multiple timepoints up to 2 months post-treatment.