View clinical trials related to Tetraplegia.
Filter by:The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.
This research study is being done to develop a brain controlled medical device, called a brain-machine interface or BMI, that will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts. Developing a brain-machine interface (BMI) is very difficult and currently only limited technology exists in this area of neuroscience. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb. The device being used in this study is called the NeuroPort Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One NeuroPort Array consists of a small grid of electrodes that will be implanted in brain tissue with a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude though the scalp to allow for connection with the computer equipment. The investigators hope to learn how safe and effective the NeuroPort Array is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands. To accomplish this goal, two NeuroPort Arrays will be used.
The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons with tetraplegia. Despite the known challenges to the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F) causes body core temperature to decrease in persons with tetraplegia and if that decrease is related to a decrease in mental performance. After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are: Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately 1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of the persons with tetraplegia will show a decline in mental performance (memory or clear-headedness) while only some of AB controls will show a decline. The second aim of this study is to determine if a 10 mg dose of an approved blood pressure raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core temperature and (2) prevent or delay the decline in mental performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in the same group. Hypotheses (3 & 4): The changes in blood flow to the skin caused by taking a one-time dose of midodrine will lessen the decline in Tcore and prevent or delay the decline in mental performance compared to the changes in Tcore and mental performance during cool temperature exposure without midodrine in the group with tetraplegia.
This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a randomized or experimental study, no specific hypotheses are proposed. The data collected will enable us to answer the following research questions: 1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS stimulus parameters, abandonment of DPS and related reasons). 2. What mechanical problems have DPS users encountered (system failure, repairs needed)? 3. What are the frequency of and reasons for rehospitalization following DPS implant? 4. What levels of care are needed at home to manage the DPS? 5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste, swallowing)?
The cervical spine is most commonly injured, accounting for 53.4% of spinal injuries. More than 40% of all spinal injuries occur at either C4, C5 or C6 levels leading to variable loss of function in the upper extremities. Traditionally, patients sustaining a cervical spine injury were followed for 2 years to ensure that recovery had stabilized before offering upper extremity reconstruction. This type of reconstruction includes active muscle transfer, tendon transfer and joint fusion. Patients are most commonly assessed immediately at the time of injury. Muscle testing is commonly performed using Medical Research Grading System (MRC). Although complete neurologic stabilization may not be complete until 2 years post-injury, in the group with initial grade 0 muscle strength after the acute phase of injury, expectations of improved muscle strength to or beyond grade 3 after 4-6 months is minimal. And grade 3 muscle strength is felt to be the minimum useful functional strength in a muscle group. The investigators propose an early nerve reconstruction approach to the tetraplegic patient with dysfunction of the upper extremity to augment the available tendon transfers. A comparative pilot study is proposed to determine the effectiveness of supinator branch to posterior interosseous nerve (PIN) transfer in 5 patients with cervical spine injury. Patient who fits inclusion criteria will be offered the opportunity to be involved in the study and reviewed at 6 months from injury. If the patient still has not regained Grade 3 power in finger or thumb extension, they will be randomized to be in a surgical group or non-surgical group. If informed consent is obtained, then surgery will be completed between 6-9 months from the patient's original cervical spine injury. The patient will be followed at regular intervals post-operatively with expectation of 18-24 month follow-up. Measures will be used pre and post-operatively for comparison. Measures will include MRC muscle grade (EDC), range of motion, Disability of the Arm, Shoulder, and Hand Questionnaire (DASH), and The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) (Kalsi-Ryan, 2011).
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.
Corsets are often used in the management of patients with a spinal cord injury. They may help to rigidify the patients' trunk which might help some patients to sit upright; their use may also reduce the sensation of dyspnea some patients have while sitting upright. Due to spinal cord injury, abdominal muscles are weakened which can contribute to alter the respiratory function of the patients. But the corset by rigidifying the abdominal wall can improve the efficiency of the respiratory muscles in some patients and reduce dyspnea in the sitting position for some patients. However, when patients with spinal cord injury are followed over time, one can observe that some patients discontinue corset use. The investigators observed that the patients who pursue the corset use still have a significant improvement of their respiratory function with the corset while the patients who have discontinued the use have improved their respiratory function in the upright position (without the corset). As of now, the investigators do not know whether the use of the corset is discontinued because of a spontaneous improvement of the respiratory function or whether discontinuing the use of the corset may help to develop abdominal spasticity and therefore to improve respiratory function. The investigators seek to investigate this issue in order to optimize the management of patients who present spinal cord injury.
The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device. The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
Sleep-disordered breathing (SDB) occurs in 2% to 4% of the non-disabled adult population and is characterized by periods of complete breathing cessation (apnea) or marked reductions in airflow (hypopnea) during sleep. By contrast, the diagnosis of SDB affects as many as 83% of persons with tetraplegia within one year of their injury. While some consider daytime somnolescence from poor sleep quality a 'tolerable annoyance', SDB can decrease near-term physical performance and mental alertness, decay memory and intellectual processing, invoke mood disturbances, decrease healthrelated quality of life(HRQoL), and cause vehicular or occupational injury. Recurrent sleep arousal is now strongly associated with cardiometabolic (CM) component risks including insulin resistance, obesity, inflammatory stress, and endothelial dysfunction. Despite considerable advancements in understanding and treating SDB - including favored use of positive airway pressure (PAP) - an evidence base sufficient to warrant routine evaluation and treatment of SDB and related sleep disorders remains elusive for those with spinal cord injury (SCI). To address these knowledge and treatment shortcomings the investigators will conduct a hypothesis-driven study with specific aims that will: 1) describe by stakeholder survey the clinically-relevant determinants of sleep quality in persons with chronic tetraplegia, 2) assess clinical features and co-morbid risks associated with SDB in persons with tetraplegia, and 3) determine in persons with tetraplegia having SDB whether treatment using PAP reduces health risks and improves HRQoL. Hypothesis 1 will be tested using data derived from a website survey.