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Quadriplegia clinical trials

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NCT ID: NCT01899664 Completed - Clinical trials for Spinal Cord Injuries

Upper Extremity Surgery in Spinal Cord Injury

Start date: June 2012
Phase: N/A
Study type: Interventional

The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). The investigators' hypothesis is that nerve transfers are safe and effective and will improve function and quality of life in patients with loss of upper function due to spinal cord injury. The investigators plan on looking at upper limb function, and health-related quality of life in patients before and after surgery to better understand how patients benefit from these treatments. A nerve transfer procedure can be used to rewire the system to make some muscles work again following SCI. The nerve transfer procedure (which is done in the arm and not at the level of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the brain to a muscle that became disconnected following that injury. A donor nerve is taken from another muscle whose use is not essential and then transferred to help in providing more a more critical function. For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp small objects between the fingers that occurs in many patients with cervical SCI. In this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb and index finger. Because the nerve transfer procedure involves cutting and reattaching nerve and muscle tissues, time is required to regenerate working connections between the nerves and muscle as well as to allow the brain to relearn how to use and strengthen that muscle.

NCT ID: NCT01896037 Completed - Spinal Cord Injury Clinical Trials

Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

Start date: July 2013
Phase: Phase 4
Study type: Interventional

People with a spinal cord injury (SCI) characteristically have low levels of high-density lipoprotein-cholesterol (HDL-c; "good cholesterol") and high levels of low-density lipoprotein-cholesterol (LDL-c; "bad cholesterol"), and are at a higher risk of developing cardiovascular health problems, such as heart disease, heart attack and stroke, than the able-bodied population. A common way for able-bodied people to improve their lipid profile is through exercise; however, SCI people, especially tetraplegics, are often unable to achieve and maintain a level of exercise needed to obtain these benefits. It is therefore clinically important to find an effective, safe and inexpensive method of increasing HDL-c levels in people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of cardiovascular health issues.

NCT ID: NCT01849822 Completed - Tetraplegia Clinical Trials

Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

Start date: February 2013
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01822535 Completed - Clinical trials for Mild Cognitive Impairment

Body Temperature in Persons With Tetraplegia When Exposed to Cold

Start date: July 2011
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01815554 Completed - Spinal Cord Injury Clinical Trials

Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia

Start date: January 2013
Phase: N/A
Study type: Observational

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)?

NCT ID: NCT01741389 Completed - Clinical trials for Spinal Cord Injured, Tetraplegia

The Role of Melatonin in the Regulation of Blood Coagulation

COME
Start date: December 2012
Phase: Phase 1
Study type: Interventional

The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.

NCT ID: NCT01467856 Completed - Clinical trials for Sleep Disordered Breathing

Sleep Disordered Breathing

SDB
Start date: October 2010
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01393444 Completed - Spinal Cord Injury Clinical Trials

ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.

NCT ID: NCT01350297 Completed - Tetraplegia Clinical Trials

Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency

TETRADIA-UNI
Start date: March 2010
Phase: Phase 4
Study type: Interventional

This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

NCT ID: NCT01202019 Completed - Spinal Cord Injury Clinical Trials

Effects of Exercise in People With Tetraplegia

Start date: March 2008
Phase: N/A
Study type: Interventional

This study is designed to assess the impact of exercise and supplementation on measures of fitness, function, and cardiovascular disease risk factors/modifiers in individuals with spinal cord injury (SCI). The primary purpose of this study is to improve fitness and function, reduce cardiovascular disease risks, and enhance oxidation of dietary and body fats in persons with chronic tetraplegia through acute exercise, exercise conditioning, and dietary supplementation. This study will test the hypothesis that timing of supplementation with regards to exercise bout ('intervention/placebo') affects fitness, function, lipid profiles, lipid oxidation, and inflammatory markers after acute exercise and chronic conditioning.