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Stroke clinical trials

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NCT ID: NCT01945151 Recruiting - Clinical trials for Cerebrovascular Accident

Analysis of the Electrical Muscle Activity and Resistance to Movement in Spastic Hemiparetic Patients.

EENM
Start date: June 2013
Phase: N/A
Study type: Interventional

To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients. The specific objectives are: - Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in spastic muscle (gastrocnemius). - Evaluate the resistance movement, strength and muscle electrical activity before and after application of Neuromuscular Electrical Stimulation in the spastic antagonist muscle (tibialis anterior). - Compare the risk of falls after application of Neuromuscular Electrical Stimulation in both muscles studied.

NCT ID: NCT01941147 Recruiting - Stroke Clinical Trials

Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

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

There is great interest in the development of novel therapies for acute ischemic stroke because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for acute ischemic stroke therapy because of their effects on the main mechanisms of brain ischemic damage and regeneration.The main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective tool to promote recovery in acute ischemic stroke patients Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be evaluated by the incidence of adverse events and mortality throughout the stimulation period and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical and radiological scores.

NCT ID: NCT01937910 Recruiting - Stroke Clinical Trials

Neuroplastic Change in Myelin of the Brain

Myelin
Start date: September 2014
Phase: N/A
Study type: Interventional

The main goal of this research is to advance understanding of how stroke changes both the structure and function of the brain. The investigators will determine which is the key driver of recovery of arm function after stroke: changes in the structure of the brain or changes in how brain regions interact with one another.

NCT ID: NCT01934725 Recruiting - Ischemic Stroke Clinical Trials

Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome

SECRETO
Start date: November 2013
Phase:
Study type: Observational

BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes occur at younger ages. Stroke at young age causes marked disability at worst and thus long-standing socioeconomic consequences and exposes survivors for 4-fold risk of premature death compared with background population. Up to 50% of young patients with ischemic stroke remain without definitive etiology for their disease despite extensive modern diagnostic work-up (i.e. cryptogenic stroke). The group of cryptogenic strokes includes those with patent foramen ovale (PFO) or other abnormalities in the atrial septum in the heart as the only or concomitant finding. Population prevalence of PFO is high, 25%, and the mechanisms how PFO would be associated causally with ischemic stroke remain to be clarified. Moreover, there are only scarce data on clinical outcome, long-term risk of new vascular events, and prevention of such events in these patients. DESIGN: Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter case-control study of young adults (age 18-49) presenting with an imaging-positive first-ever ischemic stroke of undetermined etiology (aim N=2000). Patients are included after standardized diagnostic procedures (brain MRI, imaging of intracranial and extracranial vessels, cardiac imaging, and screening for coagulopathies) and age- and sex-matched to healthy controls in a 1:1 fashion. Up to 45 study sites worldwide will be needed to recruit the planned participant population during a 3-year period. Neurovascular imaging and echocardiography studies, and ECGs will be read centrally. AIMS: SECRETO involves five principal fields of investigation: (1) Stroke triggers and clinical risk factors; (2) Long-term prognosis (new vascular events, functional and psychosocial outcomes); (3) Abnormalities of thrombosis and hemostasis; (4) Biomarkers of e.g. inflammation, atherogenesis, endothelial function, thrombosis, platelet activation, and hemodynamic stress to characterize postulated cryptogenic stroke mechanisms; and (5) genetic study, including genome-wide association and candidate gene studies as well as next-generation sequencing approach. All analyses consider cardiac functional and interatrial structural properties as a possible mediator. Furthermore, SECRETO Family Study (substudy) aims at collecting extensive family history of thrombotic events from informative patients being screened for SECRETO main study and collect genetic samples from all consenting family members for whole-genome sequencing. SIGNIFICANCE: SECRETO will provide novel information on clinical and subclinical risk factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young adults. This study also reveals long-term prognosis of this understudied patient population and may discover new genetic background underlying the disease mechanism and provide potential targets for drug development.

NCT ID: NCT01918748 Recruiting - Multiple Sclerosis Clinical Trials

Effect of I-TRAVLE Training on Arm Function in MS and Chronic Stroke Patients

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

Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke patients have not reached their full potential when they are discharged from hospital. It is proven that extra training opportunities lead to further improvement. To date, new training possibilities, such as robotic techniques for rehabilitation, virtual reality training systems and tele-rehabilitation are being developed to aid in the training of stroke patients. Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime, featuring a robotics-based self-adapting arm training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm) muscle strength. Study design: single arm prospective cohort study. Study population: 16 stroke patients in the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the arm, having low to moderate proximal (shoulder and arm) muscle strength. Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or challenges the patient to perform movements of the arm, thereby training motor control and co-ordination of the affected arm. Also strength and endurance of arm muscle use may be trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at least half an hour to avoid (general) fatigue and overuse. Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the start of the intervention, each interspaced by 1 week to assess baseline stability or any fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training. Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling. Secondary outcome measures are: motricity index, plate tapping task, active range of motion, perceived strength and fatigue.

NCT ID: NCT01880268 Recruiting - Clinical trials for Cerebrovascular Accident

Wireless Brain-computer-interface-controlled Neurorehabilitation System for Patients With Stroke

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

This study integrates the wireless EEG system with an ordinary rehabilitation device (an upper limb ergometer, "arm bike") used in the Department of Physical Medicine and Rehabilitation at our hospital for a brain-computer-interface (BCI)-controlled neurorehabilitation device, and aims to test the effectiveness of this device. We hypothesize that, the coupling of electroencephalographic signals related with initiation of limb movements with a mechanical device which assists the intended movement is effective to facilitate motor recovery in patients with brain lesion. We propose to enroll 20 patients with cerebrovascular accident (CVA) (4-24 months after the onset of CVA) and the patients will be randomly assigned to experimental (using BCI controlled device and undergoing standard rehabilitation) and control groups (undergoing standard rehabilitation alone). To compare the rehabilitation results among these groups, we propose to use various assessment tools including clinical evaluation (Fugl-Meyer assessment, Modified Ashworth scale, Motor Activity Log, Functional Independence Measure) as well as functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI) before, immediate and 2 months after completion of the training protocol.

NCT ID: NCT01862978 Recruiting - Clinical trials for Acute Ischemic Stroke

Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke

Heparinas
Start date: May 2013
Phase: Phase 4
Study type: Interventional

The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours. Randomized patients will be divided into three groups. The first group of patients will receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT. After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic dose. Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose as recommended. The third group of patients are those who will receive placebo intravenously and 24 hours after receiving nadroparin subcutaneously in the therapeutic dose. All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally. For initiation of treatment will be assessed: - Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion criteria - Sign the informed consent and patient randomization - Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic coagulation - Women of childbearing age (pregnancy test) - History, clinical presentation, medical history, basic internal review of the status (blood pressure, pulse, body temperature, etc.). - Initial CT examination of the brain - EKG - USG sections of extracranial carotid and vertebral arteries - special hematology factors If a patient meets all the necessary criteria, he may be given the test substance. During the first 24 hours will be monitored at regular intervals vital functions. After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also 100 mg of aspirin per orally. In the interval from 24 to 30 hours of starting treatment the patient will be made: - Control CT brain - EKG - Basic coagulation - Reduction to stop treatment for newly identified haemorrhage or severe and extensive focal cerebral ischemia by CT scan - special hematology factors 72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel Index. Safety endpoints: mortality, adverse side effects, bleeding

NCT ID: NCT01855633 Recruiting - Stroke Clinical Trials

Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

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

Stroke is one of the major causes of death in the World. Many stroke survivors may suffer from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy are limited. The development of new treatment strategies is essential. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area of the brain for restoring brain function. The aim of this study is to investigate the therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.

NCT ID: NCT01832428 Recruiting - Stroke, Clinical Trials

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.

BMACS
Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

NCT ID: NCT01822964 Recruiting - Stroke Clinical Trials

Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II

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

The aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI) procedures. From start of anesthesia, until final valve implantation, local cooling (by the RhinoChill device) will be applied to the brain. Effect of cooling on cerebral oxygenation, by cerebral oxygen saturation monitoring (NIRS ForeSight technology) during the TAVI procedure will be continuously assessed during native valve manipulation and during final valve deployment (=primary endpoint of he study). As secondary endpoints, neuropsychological testing performed before and after TAVI procedure will assess the effects of the use of cooling during the TAVI procedure. Neuron-specific enolase (NSE) and S100-beta will be analyzed during and up to 72hrs after TAVI to compare the cerebral ischemic damage between cooled and non-cooled patients. And finally, diffusion-weighted MRI of the brain will be performed 5 days before and 5-7 days after TAVI to compare the number and total amount of cerebral ischemic insults between cooled and non-cooled patients. The hypothesis behind this study is that by local cooling of the brain during manipulation of the calcified aorta and aortic valve, the brain might be protected from cerebral ischemic insults.