Clinical Research Directory

Human-like Robotic Controllers for Enhanced Motor Learning

The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other co-robots. The investigators will develop models for a single joint robot (i.e. at the ankle joint) that can vary its haptic behavioral interactions at variable impedances, and replicate in a multi-joint robot (i.e. at the ankle, knee, and hip joints). The investigators will collect data from healthy participants and clinical populations to create a controller based on our models to implement in the robots. Then, the investigators will test our models via the robots to investigate the mechanisms underlying enhanced motor learning during different human-human haptic interaction behaviors (i.e. collaboration, competition, and cooperation. This study will be carried out in healthy participants, participants post-stroke, and participants with spinal cord injury (SCI).

Evaluation of an Advanced Lower Extremity Neuroprostheses

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.

The Impact of Injustice Appraisals on Psychosocial Outcomes Following Spinal Cord Injury: A Longitudinal Study

The primary objectives of this study are to: (1) determine the longitudinal course and impact of injury-related injustice appraisals among civilians and Veterans who have recently acquired a spinal cord injury (SCI), and (2) use qualitative inquiry to gain a rich, contextual understanding of appraisals of injustice during the first year after acquired SCI. The long-term goal of this research is to inform the development of new treatment approaches targeting appraisals of injustice.

Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury

The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain. Researchers will compare EC5026 to placebo. Participants will be asked to: * Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days. * Undergo physical exams, vital signs assessments, ECGs, and blood draws * Complete assessments of pain, sleep, functional status, and perception of change

Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury

The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm. It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI). This study requires 30 visits, and each visit will last approximately 1.5 hours.

Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury

This research study aims to explore people's understanding of physical activity behavior and perceptions of what a physical activity program should include for supporting initiation and continuous participation. This study will enroll up to 30 adults (18 or over) with spinal cord injury. The study will use a discrete choice experiment (DCE) design that implements both quantitative (development of preference survey) and qualitative approaches (systematic review; test of preference survey).

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

QUESTION. Does duroplasty improve outcome after spinal cord injury? WHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury. WHY SPINAL CORD INJURY? Spinal cord injury is a devastating condition that causes permanent disability such as paralysis, numbness and loss of bladder and bowel control. Currently, there are no treatments shown to improve outcome after spinal cord injury. WHAT IS DUROPLASTY? Duroplasty is an operation that involves opening the tough membrane around the cord, called the dura, and stitching a patch of artificial dura to expand the space around the swollen cord. WHY IS DUROPLASTY BEING STUDIED? Based on our preliminary evidence, we think that the dura causes cord pressure after injury. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord. WHO IS ELIGIBLE? Adult patients with severe spinal cord injuries in the neck who will have surgery within 72 hours. WHAT TREATMENT? Those who agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Some patients will also be asked to take part in a smaller study that involves placing probes at the injury site. WHERE? Initially, we will recruit patients from U.K. Major Trauma Centres. Most assessments will be done in U.K. Spinal Injury Centres. Later on, we we also started recruiting from overseas. HOW LONG? We aim to recruit 222 - 260 patients over 4 years. Patients will be followed up for a year. WHAT DO WE ASSESS? Patients will be assessed (using questionnaires and by examination) how well they can use their hands, walk, control their bladder and bowel and their quality of life. Some of these assessments will be repeated at 3, 6 and 12 months after surgery. WHAT IS THE OPTIONAL MECHANISTIC STUDY? DISCUS includes an optional study for at least 50 patients who will take part in the randomised controlled trial. The aim of the mechanistic study is to determine how duroplasty improves outcome, i.e. whether duroplasty reduces cord compression, improves blood flow to the injured cord perfusion, improves cord metabolism and reduces cord inflammation. WHAT IS THE OPTIONAL INFORMATION STUDY? For the first two years, a study called QuinteT Recruitment Intervention (QRI) is designed to optimise patient recruitment and informed consent in the trauma setting.

Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy. The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.

Dosing of Overground Robotic Gait Training With Functional Outcomes and Neuroplasticity After Spinal Cord Injury

The DOOR SCI project examines dosing effects of robotic gait training (RGT) and transcranial magnetic stimulation (TMS) initiated during inpatient rehabilitation and continued through early outpatient rehabilitation

Spinal Stimulation + FES-Assisted Cough Training in SCI

The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.

Acupuncture in Spinal Cord Injury Subjects

Of the more than 250,000 Americans with severe spinal cord injury (SCI), 42,000 are military veterans. The Department of Veterans Affairs is the largest single network of SCI care providers in the nation. Patients with SCI experience functional disabilities as well as chronic pain. Studies show that individuals with SCI report pain refractory to conventional treatments. Civilian and veteran patients with SCI have associated pain with impairments in physical and cognitive function, sleep, employment, social relationships, community re-integration and quality of life. In a survey of individuals with SCI, those who used acupuncture experienced a reduction of pain symptoms lasting hours after treatment, with 27.3% reporting pain relief for days. A pilot study on the use of auricular acupuncture for neuropathic pain associated with SCI showed a greater reduction of pain as measured by the Numerical Rating Scale (NRS). A recent review of randomized controlled trials regarding the use of acupuncture in SCI found that only two of sixteen included studies were of high quality. There was limited evidence for the use of acupuncture in motor functional recovery, bladder function recovery, and in pain control related to SCI. Further high quality studies are needed. This proposal is for a phase II randomized clinical trial.

Efficacy of a Wearable Noninvasive Neuromodulation Device

The aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. a sham control intervention on NBD symptoms in patients with SCI. The study hypotheses: * The proposed TNM treatment at a leg point will reduce NBD symptoms between baseline and post-therapy, when compared to the sham-TNM treatment. * The therapeutic effect of TNM to improve the NBD symptoms is associated with improvement of the autonomic function in SCI patients.

Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease

The investigator is evaluating data stored on the Collaborative Community Clinic data repository (IRB #201811032). Researchers seek to evaluate the effectiveness of the Collaborative Community Clinic (CCC), an occupational therapy student experiential learning clinic for uninsured or under-insured people with spinal cord injury and disease (SCI/D), using participants' initial and follow-up assessment batteries.

AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI

Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.

Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health

Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an obesity rate of over 90% and a metabolic syndrome rate of 60%. These results are significantly higher than in the general population. As such individuals with SCI typically have systemic inflammation and an accelerated trajectory towards cardiometabolic disease, and early mortality. Although the accelerated trajectory is multi-factorial, substantial evidence implicates sedentary behavior and low physical activity levels as significant contributing factors. Exercise strategies for individuals with SCI have included upper body arm crank exercise (ACE), functional electrical stimulation leg cycling exercise (FES-LCE), or a combination of the two (FES Hybrid Exercise). These modalities have yielded modest improvements in physical fitness and cardiometabolic risk profiles in individuals with SCI. FES-LCE reportedly increased lean-to-fat mass ratio, enhanced peripheral blood flow and vasoreactivity, and increased bone mass in the paralyzed legs. In addition, FES-LCE improves metabolic function as evidenced by increased glucose disposal. There is evidence that high-intensity interval training exercise can increase muscle mass and improve cardiovascular fitness with considerably less time commitment than non-interval activities. However, given many individuals with SCI respond poorly to the onset of training a primer exercise program for the extremely deconditioned muscles is recommended for optimal results. The investigators intend to investigate the optimization of benefits by using a novel hybrid FES cycling protocol (FES legs cycling plus voluntary arms cycling) combined with high intensity interval training (HIIT) and preceded by a preparatory muscle strengthening program called "peripheral remodeling intermittent muscular exercise (PRIME) to prepare the deconditioned muscles for the more intense exercise in the hybrid HIIT-FES cycling program. The investigators hypothesize that individuals in the PRIME + hybrid HIIT-FES cycling program will demonstrate significantly greater cardiometabolic health and functional benefits than the control group receiving standard of care range of motion exercises.

Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury

The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury. The main questions this study attempts to solve: 1. What are the immediate effects of spinal cord transcutaneous stimulation on BP? 2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?

Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury

The purpose of this study is to compare two types of wearable lower-extremity exoskeletons -a self-balancing device lower-extremity exoskeleton and a user-balancing device lower-extremity exoskeleton-to better understand their effects on the physiological responses to walking and the user experience in people with spinal cord injury.

Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain

The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.

Diet and Fat Mass After Traumatic Spinal Cord Injury

This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.

Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury

The purpose of this study is twofold: (1) Develop a new evaluation scale for mental body representations (MBR, i.e., body awareness and visuospatial body maps) for adults with spinal cord injury (SCI) with and without neuropathic pain. (2) Assess the psychometric properties of usability, reliability, and validity of the new evaluation scale This is a cross-sectional observational study design. For Aim 1, this study will involve initial item generation for a novel MBR evaluation scale for SCI through email communication, and individual interviews proctored remotely through Zoom, or, if preferred by the participant, in-person. For Aim 2, the study will include a Zoom call for consenting and questionnaires, as well as an in-person visit where participants will be tested with the new SCI-BodyMap evaluation scale, and a questionnaire asking about the usability and satisfaction of the new evaluation scale.

Nerve Transfer After Spinal Cord Injury- Multi-center

Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.

ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.