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Spinal Cord Injury clinical trials

View clinical trials related to Spinal Cord Injury.

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NCT ID: NCT02459028 Completed - Chronic Pain Clinical Trials

Positive Psychology Interventions in Individuals With Chronic Pain and Spinal Cord Injury

T3P
Start date: May 2015
Phase: Phase 2
Study type: Interventional

Background: Chronic pain is one of the most burdensome potential consequences of a physical disability, such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology intervention showed a significant reduction in pain intensity, pain interference, pain catastrophizing and depression and an enhancement of subjective well-being and control over pain in persons with chronic pain secondary to a physical disability. Study Objective: Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P) in a community-based, single-blind, randomized, controlled, parallel group trial on subjective well-being and pain in individuals with chronic pain secondary to SCI. Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in subjective well-being, and perceived control over pain and (2) greater immediate and long-lasting decrease in depression, pain intensity, pain interference and catastrophizing, relative to an active control treatment. Specific aim 1: To increase the understanding of the mechanisms underlying T3P by determining potential mediation effects. Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain intensity, and (2) positive and negative affect mediate the effect of T3P on life satisfaction and depression. Objective 2: To identify for whom T3P is most effective by exploring potential moderator effects. Study Design: The proposed study is a single-blind, randomized, controlled trial with a parallel group design to determine the effects and mechanisms of T3P in a Swiss community sample of persons with chronic pain secondary to SCI.

NCT ID: NCT02458469 Completed - Spinal Cord Injury Clinical Trials

Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

REST-SCI
Start date: May 14, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.

NCT ID: NCT02455336 Completed - Spinal Cord Injury Clinical Trials

Fenofibrate Treatment in SCI

Start date: May 18, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emerges, which is characterized by low serum high density lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an independent risk factor for coronary artery disease, and elevations in serum triglycerides (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually similar to those of the general population. The current proposal in persons with SCI aims to determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid medication whose primary action lowers serum TG and raises serum HDL-C levels.

NCT ID: NCT02451683 Recruiting - Spinal Cord Injury Clinical Trials

Corticospinal Function After Spinal Cord Injury

Start date: October 12, 2020
Phase: N/A
Study type: Interventional

The investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.

NCT ID: NCT02446210 Recruiting - Spinal Cord Injury Clinical Trials

Neuroplasticity After Spinal Cord Injury

Start date: January 28, 2021
Phase: N/A
Study type: Interventional

The long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.

NCT ID: NCT02427230 Completed - Clinical trials for Urinary Incontinence

Treatment of Urinary Incontinence in Women With Spinal Cord Injury

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary incontinence and improving quality of life in women with spinal cord injury (SCI).

NCT ID: NCT02425332 Completed - Spinal Cord Injury Clinical Trials

Validation of a Novel Robot-aided Assessment of Gait Ability

Start date: May 2015
Phase: N/A
Study type: Interventional

The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.

NCT ID: NCT02417532 Completed - Spinal Cord Injury Clinical Trials

Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

RAPPER II
Start date: May 2015
Phase: N/A
Study type: Interventional

Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.

NCT ID: NCT02412046 Terminated - Spinal Cord Injury Clinical Trials

Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

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

The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We want to detect the early stage of irreversible damage for each patient. To achieve this goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First the interface pressure between the patient body and the air mattress is recorded continuously for 3 hours (= the repositioning patient frequency): we have the pressure over each point of the patient body in contact with the mattress on this time lap. Then, we will measure the microvascularization parameters, using an O2C medical device over a trochanter on a specific anatomical area which will be thereafter biopsied. Finally, depending on the group in which they were randomly distributed, the patient will undergo a muscle biopsy on his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be able to determine the effect of the mechanical strain duration on the physiologic parameters. The following day, the patient is undergoing his or her surgery for removing the necrotic area of the bedsore. At the same time, we will recover some of the sample near the bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy will be performed on an innervated area to be able to determine a basal concentration of biomarkers. The inclusion period for this study will be 3 years. All the patients are followed for 24 hours then they will be followed by medical staff in their bedsore resection setting. The data gained for this study will hopefully help the scientific world to achieve a better understanding of the pressure ulcer aetiology. They will also be helpful to achieve a mobilization of the patient specific of his or her inherent characteristics with a high sensitivity level. This way we will have a more efficient bedsore prevention.

NCT ID: NCT02406859 Completed - Spinal Cord Injury Clinical Trials

Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.