Acute Spinal Cord Injury

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.

This research aims to learn more about vitamin C deficiency in patients with either acute or chronic diseases. It focuses on understanding how symptoms change over time and how well patients tolerate treatment. The study involves patients diagnosed with vitamin C deficiency either by lab tests or based on symptoms such as fatigue, infections, bleeding gums, joint pain, and poor wound healing. The study observes patients treated with Vitamin C Injektopas® 7.5 g, given for an expected average of about 3 weeks for acute diseases or 12 weeks for chronic diseases. Two groups are included: those with acute underlying diseases and those with chronic underlying diseases, both receiving this vitamin C therapy during the study period. Participants will be followed to assess changes in general and disease-specific symptoms, as well as treatment tolerability and overall effectiveness from the patient's perspective. Researchers will also record the number of vitamin C infusions and measure quality of life for chronic disease patients. The study duration ranges up to approximately 12 weeks, with evaluations at the last visit to understand symptom improvement and treatment impact.

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.

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.

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.

Researchers are evaluating the use of abdominal functional electrical stimulation (FES) to improve bowel management time for people living with chronic spinal cord injury (SCI). The study aims to assess whether this stimulation can also enhance bowel-related quality of life, participant-reported bowel function, bowel management strategies, bladder symptoms, and reduce unplanned hospital admissions. Participants' experiences and perspectives about the stimulation sessions and device use will also be explored. All participants in this trial will receive abdominal functional electrical stimulation, where electrodes are applied to the abdomen during bowel routines to assess its effects. The intervention lasts for 10 weeks, with daily monitoring of bowel management time and safety. Stimulation dose is tracked during weeks 3 to 7, and participants complete various questionnaires at weeks 1, 3, 7, and 10 to evaluate quality of life, bowel function, bladder symptoms, and intervention acceptability. Participants will be involved in daily bowel management assessments and safety monitoring over the 10-week period. They will complete several questionnaires about their bowel and bladder symptoms, quality of life, and intervention experience at specific weeks. The study uses video-enabled smart devices and videoconferencing software to support data collection. The primary outcome measured is bowel management time, with multiple secondary outcomes to understand the broader impact of the stimulation.