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Stroke clinical trials

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NCT ID: NCT03434938 Not yet recruiting - Clinical trials for Patients (>=65 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)

IMAGINE Study Protocol

IMAGINE
Start date: February 2018
Phase: N/A
Study type: Interventional

Background: Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), a centred-person intervention aimed to empower and motivate the patient, could be a resource to improve rehabilitation and its outcomes for older stroke survivors. Objective: The IMAGINE project aims to assess the impact of MI associated to standard geriatric rehabilitation, on 30 days functional improvement measured by the Functional Independence Measure (FIM), compared to standard geriatric rehabilitation alone, in patients admitted to geriatric rehabilitation after a stroke. Secondary objectives will be to assess the impact on physical activity and performance, self-efficacy, sense of coherence, safety, cost-utility and participants' experience, plus functional status at 3 months. Methods: Multicenter randomized clinical trial in three geriatric rehabilitation departments. Older adults after mild-moderate stroke without previous dementia, post-stroke severe cognitive impairment or delirium at admission, severe previous disability, aphasia or terminal conditions will be randomized into the control or the intervention group (136 per group, total N = 272). The control group will receive written information about the benefits of exercising, besides standard rehabilitation. The intervention group, in addition, will receive 4 sessions of MI by trained nurses. A shared tailored plan based on patients' goals, needs, preferences and capabilities will be agreed. Besides the FIM, in-hospital physical activity will be measured through accelerometers (activPAL) and secondary outcomes using internationally validated scales. As a complex intervention, a process evaluation and cost-utility assessments will be performed too. Results: Final results are expected by end of 2020. Implications: This project aims to achieve impacts on functional status, disability and physical performance and behavioral (increasing physical activity) and psychological implications (on general self-efficacy and sense of coherence) through a non-pharmacological and likely accessible, acceptable and scalable intervention. Efficiency and value, based on costs/quality adjusted life years, will be assessed. Moreover, a reduction in post-stroke disability would have social benefits also for families and would reduce health and social care costs. In brief, advances will be in terms of a better rehabilitation process.

NCT ID: NCT03433235 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

Early Administration of Edoxaban After Acute Ischemic Stroke in Patients With Non-valvular Atrial Fibrillation

Start date: March 31, 2018
Phase: Phase 2
Study type: Interventional

We hypothesize that earlier initiation of edoxaban in AF-related stroke patients may significantly reduce the early recurrence of ischemic stroke, compared with conventional strategy of anticoagulation following 1-3-6-12 rule. To expedite the verification of the hypothesis, we are planning to use diffusion weighted imaging (DWI), which has been reported to be a surrogate to predict both short-term and long-term prognosis after stroke,8, 9 to detect the recurrent ischemic events. Because data on the early anticoagulation in patients with AF-related stroke are limited, we decided to perform a pilot study before establishing an appropriate clinical trial protocol. This study will help estimate the efficacy and safety of early administration of edoxaban, and determine the sample size of a following clinical trial. To ensure the safety in this pilot exploration, we will not include patients with severe ischemic strokes, who are often prone to experience hemorrhagic transformation in the acute post-stroke period.

NCT ID: NCT03431909 Completed - Clinical trials for Acute Ischemic Stroke

Evaluation Of HUK in Acute Stroke Patients: MRS and CTP

Start date: January 1, 2014
Phase: Phase 4
Study type: Interventional

Background: Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality worldwide. Human urinary kallidinogenase (HUK), a glycoprotein extracted from male urine currently used in China for enhancing cerebral perfusion5, plays a neuroprotective role including promoting angiogenesis, enhancing cerebral perfusion and suppressing the inflammatory response in animals and in patients with respect to regulating the kallikrein-kinin system. In previous clinical research, neurological function scores and cerebral perfusion scans were largely used to evaluate the efficiency of HUK. However, the mechanisms of Further well-conducted, randomized controlled studies using HUK are currently lacking. Objective: To assess the Human urinary kallidinogenase effects on brain metabolite and cerebral perfusion changes using magnetic resonance spectroscopy and CT perfusion in patients with AIS. Methods: The investigators plan to do a single-centre randomized, double-blind, controlled trial in which ischemic stroke patients will be randomized to treatment with either HUK or regular treatment within 72 hours of symptom onset. The study includes two MRS and two CTP scannings (before and after 2 week treatment) for all randomized subjects. The endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from baseline, modified Rankin scale (mRS) score and Barthel index at 14 days. EvHUKMRS will test the following hypotheses: 1. HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after treatment compared with control group. 2. HUK group compared to control group when administered 72 hours after onset of AIS improves recovery and functional outcome as assessed by improvement of NIHSS score , mRS score and BI score on day 14 post-stroke. A positive result will have a significant impact in the management of AIS and pave the way for future studies aimed at finding the optimal dose and formulation of HUK for treating acute ischemic stroke.

NCT ID: NCT03431402 Recruiting - Acute Stroke Clinical Trials

Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Background and Rationale: Cerebrovascular disease is always ranked at the top causes of death and most of hospitalized acute stroke patients have ischemic stroke [1]. Although the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke [1], it still results in patient disabilities and complications that often lead to significant costs to individuals, families, and society. Traditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting tissue plasminogen activator (t-PA) within three hours after onset of symptoms [2], antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically, the narrow time window of thrombolytic therapy and coexisting contraindications limit the use of t-PA [2]. Thus, searching for an effective supplemental treatment for acute ischemic stroke is imperative. Hyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning [3,4], air or gas embolism [5], facilitating wound healing [6] and has been used as an adjuvant treatment for many neurological disorders that need further study as concussion [7] , stroke [8,9], cerebral palsy [ 10],traumatic brain injury [ 11], cerebral air embolism [12], Autism [13] and multiple sclerosis [14]. Indications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical society (UHMS) [15] are 1.air or gas embolism [5], 2.carbon monoxide poisoning [3,4], 3.clostridial myositis and myonecrosis [16], 4.crush injury, compartment syndrome and other acute traumatic ischemias [17], 5.decompression sickness [18], 6.arterial insufficiencies [19], 7.severe anemia [20], 8.intracranial abscess [21], 9.necrotizing soft tissue infections [22],10. refractory osteomyelitis [23], 11.delayed radiation injury [24], 12.compromised grafts and flaps [25], 13.acute thermal burn injury [26] and 14.idiopathic sudden sensorineural hearing loss [27]. Known mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema, and improving metabolism after ischemia [28,29]. Furthermore, a recent study performed on a rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF) and nerve growth factor (NGF) might underlie the effect of HBOT [30]. The effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still controversial that need further evaluation.

NCT ID: NCT03431025 Not yet recruiting - Stroke Clinical Trials

Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.

NCT ID: NCT03430375 Not yet recruiting - Stroke Clinical Trials

Wheelchair Cushion Comparison Study: SAFETY

Start date: February 2018
Phase: N/A
Study type: Interventional

Purpose: To examine the safety of the use of two wheelchair cushions for healthy individuals with intact sensation and individuals post stroke and spinal cord injury with impaired sensation. The new Ease Alternating Pressure wheelchair cushion will be compared to a static air cushion to examine interface pressure and skin responses in the areas of the buttock and posterior thighs when subjects sit without moving (static condition) and during upper extremity reaching activities (active condition). In addition, comfort, ease of transfer, and postural stability will be monitored while sitting on both cushions under both static and active conditions.

NCT ID: NCT03429855 Not yet recruiting - Stroke, Acute Clinical Trials

Bobath Approach for Trunk Control in Acute Stroke Patients

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

In stroke patients, the impairment of the trunk affects many functions negatively. For this reason\ training of the trunk is necessary in the early period. Taking into account of literature, various approaches have been used to improve sitting balance and trunk control such as conventional physiotherapy for stroke patients . Bobath concept is another method used for stroke rehabilitation. When the studies about stroke rehabilitation are investigated, it is seen that most of the studies included only chronic patients and Bobath concept did not adequately take place in literature about trunk training. The aim of this study is to determinate effectiveness of the Bobath based trunk training on trunk control in acute stroke patients.

NCT ID: NCT03428659 Not yet recruiting - Sub-acute Stroke Clinical Trials

Functional Recovery Changes in Subacute Stroke Patients

Start date: February 12, 2018
Phase: N/A
Study type: Observational [Patient Registry]

In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset

NCT ID: NCT03427645 Recruiting - Stroke Clinical Trials

Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers

Start date: February 8, 2018
Phase: N/A
Study type: Interventional

The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves. A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.

NCT ID: NCT03426982 Not yet recruiting - Stroke Clinical Trials

Comparision Between Anti-Xa activiTy Versus aCtivated Partial Thromboplastin Time in Heparin Monitoring

CATCH
Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

Background: Unfractionated heparin (UFH) is a sulfated polysaccharide extracted from porcine intestinal mucosa that enhances the inhibitory activity of the natural anticoagulant antithrombin towards most activated clotting factors (F), particularly FXa and FIIa (thrombin) (1,2). Despite the growing interest for low molecular weight derivatives (LMWH), UFH is still widely used for different indications including the treatment of acute thrombosis including venous thromboembolism, coronary syndromes (ACS), and other thrombotic diseases (3). UFH is administered by parenteral route either intravenous (IV) or sub-cutaneous (SC).Actually, there is evidence that the risk of recurrence of thrombosis is increased when heparin levels fells below the lower limit of the therapeutic range, while the hemorrhagic risk increases with heparin levels above the upper limit of the therapeutic range. Moreover, the anticoagulant response to UFH is highly variable for one individual to another (4). As the clinical efficacy of heparin is dependent on maintaining an anticoagulant effect above a minimum level, careful laboratory monitoring of UFH treatment is mandatory (3). For that purpose, two options are offered to the clinicians: i) to evaluate either the prolongation of a global clotting assay, the activated partial thromboplastin time (aPTT) and ii) to measure the heparin-enhanced inhibitory activity of AT toward purified activated factors such as FIIa and FXa using chromogenic substrate-based assays (3). UFH therapy is still widely monitored by the aPTT, a global clotting assay, that reflects the ability of heparin to enhance the inhibitory activity of AT against FIIa, FXa, and other activated factors. The therapeutic range of aPTT prolongation is highly dependent on the reagent and analyzer used. As the consequence, it must be defined by each laboratory in its own technical conditions (for each reagent batch) to correlate with heparin levels between 0.20 and 0.40 U/mL (protamine sulfate titration), corresponding to anti-FXa activity between 0.30 and 0.70 IU/mL (3). In that connection, the prolongation of aPTT corresponding to antiFXa activity between 0.30 - 0.70 IU/mL is highly variable depending of the reagents e.g.between 1.6 - 2.7 x control for weakly sensitive reagents and between 3.7 - 6.2 x control for highly sensitive reagents (5). The use of aPTT has advantages as it is easy-to-perform, quick, inexpensive but faces numerous challenges due to the significant influence of the technical conditions (reagent/instrument) on the test result, to lot-lot variation in reagent sensitivity, to the need of studies to evaluate the therapeutic range, to limited therapeutic range, and also to non-specific prolongation in the case of lupus anticoagulant, factors deficiency, inhibitors or shortening in the case of high factor levels, particularly FVIII.In contrast, the use of chromogenic anti-Xa assays has many advantages particularly a published therapeutic range for UFH i.e. between 0.30 and 0.70 IU/mL, a specificity to its interaction with AT (no Heparin Cofactor II interference by using bovine FIIa or short incubation time) and faces few challenges such as limited availability in some area and a cost that is slightly higher than that of aPTT (6). In addition, anti-Xa assays allow accurate measurement of all heparin(s) derivatives and particularly LMWHs and fondaparinux. Since the first reports in the mid-eighties, some small sized studies have compared the two monitoring strategies mainly retrospectively designed (7-11). Even though, one single prospective randomized management study evaluated the comparison between the two monitoring strategies with clinical end-points i.e. recurrence of thrombosis and bleeding complication in a cohort of 131 patients with VTE (12). All concluded to a trend toward higher, or at least similar, safety/efficacy/efficiency when patients were monitored using antiXa activity vs. aPTT. Even though differences were not significant due to the lack of power of these studies.