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Spinal Cord Injuries clinical trials

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NCT ID: NCT03139344 Completed - Clinical trials for Spinal Cord Injuries

Long Duration Activity and Metabolic Control After Spinal Cord Injury

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Skeletal muscle is the largest endocrine organ in the body, playing an indispensable role in glucose homeostasis. Spinal cord injury (SCI) prevents skeletal muscle from carrying out this important function. Dysregulation of glucose metabolism precipitates high rates of metabolic syndrome, diabetes, and other secondary health conditions (SHCs) of SCI. These SHCs exert a negative influence on health-related quality of life (HRQOL). New discoveries support that a low level of activity throughout the day offers a more effective metabolic stimulus than brief, episodic exercise bouts. The proposed study will translate this emerging concept to the population of individuals with SCI by using low-force, long-duration electrical muscle stimulation to subsidize daily activity levels. Recently, we demonstrated that this type of stimulation up-regulates key genes that foster an oxidative, insulin-sensitive phenotype in paralyzed muscle. We will now test whether this type of activity can improve glucose homeostasis and metabolic function in patients with chronic paralysis. We hypothesize that improvements in metabolic function will be accompanied by a reduction in SHCs and a concomitant improvement in self-reported HRQOL. The long-term goal of this research is to develop a rehabilitation strategy to protect the musculoskeletal health, metabolic function, and health-related quality of life of people living with complete SCI.

NCT ID: NCT03137394 Completed - Spinal Cord Injury Clinical Trials

Development of a Model of Shoulder Pain Following Spinal Cord Injury

Start date: October 1, 2017
Phase:
Study type: Observational

This study will investigate the progression of musculoskeletal (shoulder muscle flexibility, muscle strength, movement coordination, and rotator cuff health) and psychosocial (fear of movement, pain catastrophizing) impairments for the first year following SCI, starting with inpatient rehabilitation, at 6 months, and at 1 year following SCI. We will use the information obtained from this study information to develop a biopsychosocial prospective surveillance model, a method for early detection, intervention, and moderation of shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to establish effective physical and cognitive-behavioral treatment to prevent loss of function and independence in individuals with SCI who depend on their arms for activities of daily living, transfers, and wheelchair propulsion.

NCT ID: NCT03137108 Completed - Clinical trials for Motor Control in Incomplete Spinal Cord Injured Persons

Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been developed. It was suggested, that this method could be used to improve the therapy process after a spinal cord injury (SCI). The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients with incomplete SCI.

NCT ID: NCT03118960 Active, not recruiting - Pressure Injury Clinical Trials

Effectiveness of the Freedom Bed as Compared to Alternating Pressure Mattress in Treatment of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and /or Spinal Cord Injury

Start date: September 2016
Phase: N/A
Study type: Interventional

This non-randomized clinical study will compare pressure injuries and the change in pressure injuries for subjects who are placed on the Freedom Bed compared to those placed on a standard Group II Low Air Loss/Alternating Pressure Mattress in the Ventilator Unit at Northeast Center for Rehabilitation and Brain Injury. Additionally, the incidence of pneumonia, urinary tract infections, circulatory performance, sleep deprivation and caregiver self-perception on performance will be monitored and documented.

NCT ID: NCT03114345 Terminated - Spinal Cord Injury Clinical Trials

Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

VASCIP
Start date: November 22, 2017
Phase: N/A
Study type: Interventional

Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

NCT ID: NCT03113994 Active, not recruiting - Metabolic Syndrome Clinical Trials

Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk

RoBaCO
Start date: February 26, 2018
Phase: Phase 2
Study type: Interventional

Rationale: After having a spinal cord injury (SCI), people develop changes in their body composition that influences their long-term health. Individuals with paralysis after SCI will have large declines in their bone density ant increases in fat mass which increases their risk of fracture and heart disease. Therapies to prevent SCI-related changes in body composition and their health effects are needed. Drugs known as "statins" used often to reduce high cholesterol, may help to reduce bone loss and inflammation. Hypothesis: Among adults with SCI for a long time, treatment with a drug named Rosuvastatin or a sugar pill, with supplements (coenzyme Q10, calcium and vitamin D), for twelve months can decrease their endocrine metabolic disease risk by increasing bone density and reducing inflammation. Study Design: A clinical trial will be conducted in Toronto, Ontario and Miami, Florida. Subjects will get statin therapy or placebo (sugar pill) by chance. Study subjects and research staff will not know whether they are taking the study drug or a sugar pill until after the study Subjects: Fifty-four adults (age 18-60 years) with a long-term SCI and no movement below their level of injury. Treatment: Subjects will be prescribed Rosuvastatin 10 mg daily or a sugar pill. In addition, all subjects will receive 100 mg of Co-Q10 daily, calcium carbonate 1250 mg and, vitamin D 2,000 IU once a day. Data Collected: Subjects' bone density will be collected at the start and end of the study. Change in bone density between the two groups will be compared to see if one is better. Blood samples will be collected quarterly to make sure subjects are safe and do not develop problems with their liver or muscles and to measure the effects of the study drugs on inflammation throughout the body. Clinical Implications: Statins may be safe and effective therapy for adults living with SCI who are at increased risk of endocrine metabolic disease as they age.

NCT ID: NCT03112941 Completed - Clinical trials for Spinal Cord Injuries

Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau

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

To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale grading, sensory score and motor score in patients with incomplete SCI in the plateau using 0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to investigate the effect of HBO therapy on incomplete SCI in the plateau.

NCT ID: NCT03111277 Completed - Clinical trials for Spinal Cord Injuries

MR Guided Focused Ultrasound for Treatment of Neuropathic Pain

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom duration and severity than many of the other pain syndromes. Functional brain imaging has revealed that many regions of the brain are engaged by painful events, but specific areas such as the thalamus have been markedly implicated. The purpose of this study is to determine the feasibility and safety of MRI-guided focused ultrasound treatment using the ExAblate Transcranial System in patients suffering from Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for these patients.

NCT ID: NCT03111030 Completed - Clinical trials for Spinal Cord Injuries

ProACTIVE SCI Physical Activity Intervention

Start date: April 28, 2017
Phase: N/A
Study type: Interventional

This study will employ a randomized, wait-list controlled trial. A total of 30 participants (15 experimental, 15 wait-list control) between 18-65 years of age who have chronic SCI ≥ 1 year prior will be recruited. Physical activity measures will be taken using wrist-based accelerometers and the Leisure Time Physical Activity Questionnaire for people with SCI (LTPAQ). Psychosocial factors will be evaluated through questionnaires. The primary health outcome measure (aPWV), and secondary cardiovascular parameters will be assessed using a combination of echocardiography and ultrasound. Fitness will be determined using a peak oxygen consumption test on an arm-cycle ergometer. All measurement will be taken at baseline and after 9 weeks following intervention commencement. Physical activity will also be sampled mid-intervention at 4 and 7 weeks. Training will involve weekly, 10-15 minute coaching sessions for 9 weeks. All pre- and post-assessments will take place at the Blusson Spinal Cord Centre at ICORD. Intervention content will be delivered in-person, over Skype or phone, and the wrist- worn accelerometers will be delivered and picked up from the participant's home during the intervention.

NCT ID: NCT03109782 Recruiting - Clinical trials for Traumatic Spinal Cord Injury

The Austrian Spinal Cord Injury Study

ASCIS
Start date: December 2012
Phase:
Study type: Observational [Patient Registry]

Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological deficits and often has long-term effects including severe lifelong disability. Given the devastating personal and economic consequences of SCI, it is critical to collect high-quality, prospective data. SCI has not been systemically assessed in Austria, and data regarding the etiology, incidence and prevalence are missing or significantly limited. More importantly to the individuals suffering from SCI, health care for SCI patients in Austria is not concentrated in specialized SCI centers but fragmented, which might result in a less effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA) initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is defined as an organized network that uses observational methods to collect uniform longitudinal clinical data that can provide insight into current patient care parameters and evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry for patients with tSCI in Austria as a base for addressing research questions, improving patient outcomes and establishing a platform for future clinical trials. Furthermore, a major goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and bring new standardized assessment tools to the clinical setting. Due to the involvement of acute trauma hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about Spinal Cord Injury (EMSCI).