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71 active trials for Spinal Cord Injury

Motor Learning in a Customized Body-Machine Interface

People with tetraplegia often retain some level of mobility of the upper body. The proposed study will test the hypothesis that it is possible to develop personalized interfaces, which utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs and other assistive devices. If successful the project will result into the establishment of a new family of human-machine interfaces based on wearable sensors that adapt their functions to their users' abilities.

Start: February 2013

Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.

Start: August 2019

Robotic Rehabilitation for Spinal Cord Injury

Individuals with spinal cord injury (SCI) have significant functional loss and poor quality of life. Individuals with cervical SCI are suffering much worse sickness within the SCI population. Tetraplegia resulting from cervical SCI bring a formidable emotional, physical, and financial burden in our society. Hand function is especially important to people with tetraplegia. Hand function is associated with independence in many activities, and impairments in upper extremity function can compound difficulties in many other areas, such as bowel and bladder management. Thus, it is not surprising that restoring hand function was found to be a priority for individuals with tetraplegia. Nowadays, magnetic resonance imaging (MRI) plays an essential role in the diagnosis of SCI and helps to monitor disease progression and efficacy of therapies. Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI), have shown the potential to improve the understanding of human spinal cord in healthy and pathological condition, and serve as imaging biomarkers to characterize damage degree, monitor the response to treatment, and predict the outcome of intervention. Meanwhile, multi-channel EMG (Electromyography) recordings can provide a mapping of neuromuscular activities from an electrode-array. The application of robotics in upper extremity function restoration of SCI patients has been started to help SCI patients to recovery upper extremity function. Combined DTI and fMRI to monitor the recovery of upper extremity function of SCI patients, this project will provide a tailored-made EMG driven soft-robotic hand prosthesis for tetraplegia individuals. We will provide the individuals with neuromuscular rehabilitation to preserve the residual function and to enhance the functional recovery. The eventual goal is to further design a useful robotic hand for regaining partial daily function to improve the quality of life for those individuals with tetraplegia.

Start: September 2017

Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI

Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to immediate FES-RT, to a time control beginning FES-RT after a 6 month wait, or 6 months of arms-only-RT followed by FES-RT. Measures will be made at baseline and every 3 months. The investigators work will provide results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.

Start: December 2013

A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences

The general population is aging, today 12% of the United States population is older than 65 and it is estimated that by 2020 the number of people in the United States older than 65 will outnumber children younger than 5. As the general population ages, the spinal cord injury (SCI) population is also aging and it is estimated that 14% is older than 60. Although persons with SCI are living longer, life expectancy remains below that of the general population with cardiovascular and cerebrovascular diseases accounting for more than 25% of all deaths since 1995. Similar to findings in the general population, BP dysregulation may impact cognitive function, and investigators reported poorer performance on tasks of memory and attention processing in hypotensive individuals with SCI compared to a normotensive SCI cohort. Thus, it is imperative that investigators work to minimize the impact of cognitive deficits on these aspects of life quality in persons with SCI as they age. Therefore the goals of this study are: Study 1) to compare cardiovascular, cerebrovascular and cognitive function and fMRI between older individuals with SCI (50-75 years) and older age-matched controls and Study 2) to determine 3-5 year longitudinal changes in cardiovascular, cerebrovascular and cognitive function and fMRI in relatively young individuals with SCI (28-54 years) compared to relatively young age-matched controls.

Start: December 2016

Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury

This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment. In this part of the study, the investigators will treat patients with sub-acute spinal cord injury with UC-MSC transplantation or placebo.

Start: September 2019

The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.

Start: April 2017

Coronary Artery Calcification Score and Risk Factors for Coronary Artery Disease in Persons With Spinal Cord Injury

Although conventional risk factors for coronary heart disease (CHD) have been identified and routinely used to determine risk for CHD in the general population, a systematic approach to determine population-specific risk for CHD has not been performed prospectively in those with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD are high serum concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family history of premature CHD. Coronary Artery calcification (CAC) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. Studies have shown that a strong association exists between coronary calcification and coronary heart disease. The purpose of this study is to compare the CAC scores in persons with SCI with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (CAD) and to determine the relationship between CAC scores and conventional and emerging risk factors for CAD. Additionally, postprandial lipemic (elevated levels of lipids following ingestion of food) responses among individuals with SCI and control subjects will be compared, as well as the response of inflammatory markers following a high fat meal. Participants will only be tested once for these parameters.

Start: February 2012

Collection and Characterisation of Human Olfactory Ensheathing Cells

We aim to retrieve olfactory bulbs (OBs) from suitable human donors. We have defined two groups who will qualify: Group 1 - Deceased Donors: 1A: Donors after brainstem death (DBDs) undergoing solid organ donation 1B: Donors after brainstem death (DBDs) considered unsuitable for solid organ donation Group 2 - Living Donors: Neurosurgical patients undergoing anterior cranial surgery in which the olfactory nerve (ON) is cut as part of the surgical procedure. The OB of the concomitant severed ON would be donated. We aim to optimise OB collection and Olfactory Ensheathing Cell (OEC) culture and storage. We will study the effects of patient diagnosis, age, cause of death (if applicable), co-morbidities and warm ischaemic time on cell survival and regenerative function. In future studies we aim to store OECs in a GMP facility and transplant OECs into patients with spinal cord injuries.

Start: April 2018

Improving Ambulatory Community Access After Paralysis

The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.

Start: April 2012

TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males

The aim of this study is to understand what happens to muscle and bone in spinal cord injured males after four months of training using stand training, with body weight support (BWS), with testosterone replacement therapy (TRT), and electrical stimulation (ES). Specifically, researchers will investigate nerve, muscle, and bone changes in the lower limbs in response to stand training and ES when combined with TRT compared to i) standing alone with TRT; ii) stand training alone with placebo; iii) stand training alone and ES with placebo.

Start: March 2017