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NCT ID: NCT05204225 Not yet recruiting - Stroke Clinical Trials

Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Stroke is the third leading cause of disability worldwide, being the hand one of the segments whose affectation generates the greatest limitation in functionality and quality of life. Neurorehabilitation is the most effective therapy as long as it is implemented both in the early (post-hospital stages) and in an intensive approach. However, the resources of healthcare systems are not enough to address the neurorehabilitation needs of these patients. This is why the scientific literature advocates the transfer of such rehabilitation to the patient's home through therapeutic exercise programs - whose clinical and economic effectiveness has already been demonstrated - as a way of reducing the consumption of resources. Thus, telerehabilitation is suggested as one of the most viable formats. However, current telerehabilitation systems such as video games and virtual reality do not provide a fully viable solution, mainly due to the lack of scalability and penetration of the technology, and the lack of a hand approach, whose importance is crucial in the recovery of functionality and autonomy in Activities of Daily Living (ADL). Different articles and reviews confirm the potential of tablet devices to solve these issues given their scalability and the multisensory feedback they provide, making possible a more productive and intensive motor training and sensory stimulation in order to optimize cortical reorganization and neuroplasticity after a stroke. The need for a Tablet application for neurorehabilitation of the hand that follows the precepts set by the evidence has been expressed by both health professionals and patients. However, the lack of specific applications for this approach means that existing apps are used as an adaptation. This is why it is proposed the creation and preliminary validation of ReHand, the first Tablet application developed following the needs of professionals and patients, and the precepts of the most updated scientific literature, allowing the patient to perform an active therapy adapted to his limitation, and the health professional to monitor his patient's home work.

NCT ID: NCT05203224 Not yet recruiting - Ischemic Stroke Clinical Trials

Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)

Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

Patients presenting to the emergency department with acute ischemic stroke, who are are eligible for standard intravenous thrombolytic therapy within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for the trial. All participants will receive intravenous tenecteplase and endovascular thrombectomy as standard care. The trial is a Bayesian Optimised Phase 2 dose-finding umbrella trial (single arm versus objective performance criterion of 20% substantial reperfusion prior to endovascular thrombectomy based on the EXTEND-IA TNK trials NCT02388061, NCT03340493). The aim is to determine the optimal dose of intravenous dornase alfa (recombinant human DNase 1) with sufficient promise to take forward in a seamless phase 2b/3 design.

NCT ID: NCT05199662 Not yet recruiting - Clinical trials for Ischemic Stroke, Acute

Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT

EXTEND-IV
Start date: January 2022
Phase: Phase 3
Study type: Interventional

A phase III, randomized, multi-center clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and have evidence of salvageable brain tissue on perfusion imaging.

NCT ID: NCT05199194 Not yet recruiting - Stroke, Acute Clinical Trials

Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke

DIRECT-TNK
Start date: January 2022
Phase: Phase 3
Study type: Interventional

A phase III randomized, multi-center, double-blinded, placebo-controlled clinical trial that will examine two strategies for the treatment of acute ischemic stroke associated with a large vessel anterior occlusion within 4.5 hours from symptoms onset: direct endovascular treatment vs. endovascular treatment preceded by intravenous tenecteplase.

NCT ID: NCT05196737 Not yet recruiting - Stroke Clinical Trials

DDN in Stroke--COBRE

CDN
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in the muscle and relieve pain. The total study duration is 7 visits over 2 weeks. There will be 4 visits the first week, and 3 visits the second week. The first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. The second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. Dry needling will take place on the fifth visit only. During each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.

NCT ID: NCT05195983 Not yet recruiting - Acute Stroke Clinical Trials

Hemodynamic Changes in Acute Ischaemic Stroke Patients

Start date: January 10, 2022
Phase:
Study type: Observational

1. To assess Hemodynamic changes in rtPA receiving Acute Ischaemic Stroke patients. 2. To assess the efficacy of rtPA in treatment of Acute Ischaemic Stroke patients. 3. To correlate TCD findings (post treatment) with one of standard vascular imaging in AIS (CTA or MRA).

NCT ID: NCT05195658 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)

Start date: January 30, 2022
Phase:
Study type: Observational

Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using the MoMa or FlowGate catheter) with thrombus retrieval achieved through active aspiration ± stentriever use. A study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window allowing guideline-indicated reperfusion by interventional management. A registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.

NCT ID: NCT05195398 Not yet recruiting - Stroke Clinical Trials

TDCS to Improve Post-Stroke Cognitive Impairment

TIPSCI
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The investigators will conduct a randomized, double-blinded, sham-controlled trial of approximately 60 patients with minor stroke and post-stroke mild cognitive impairment (psMCI). Participants will be individually randomized on enrollment using a random number generator to treatment with anodal tDCS + computerized cognitive treatment (CCT) versus sham + CCT (approximately 30 patients in each arm). Clinical evaluation including assessment of cognition will be performed pre- and post-intervention by individuals on the study team blinded to the participant's intervention. Participants will also undergo functional neuroimaging with magnetoencephalography (MEG) pre- and post-intervention (1, 3, and 6 months post-stroke to evaluate for initial and longer-term effects of treatment on cerebral activation patterns and functional connectivity). Neuroimaging and clinical outcomes will be assessed to determine the effect of tDCS versus sham + CCT on psMCI.

NCT ID: NCT05193071 Not yet recruiting - Ischemic Stroke Clinical Trials

Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Start date: February 28, 2022
Phase: Phase 4
Study type: Interventional

The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.

NCT ID: NCT05192161 Not yet recruiting - Stroke Clinical Trials

Computational Medical Imaging and Prediction of Diffusion/FLAIR Mismatch in Stroke Patients

RADIOMIXSTROKE
Start date: January 15, 2022
Phase:
Study type: Observational

Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke. In this context, the contribution of MRI is diagnostic, etiological and prognostic. Among the MRI parameters evaluated in the acute phase of the stroke, the evaluation of the mismatch between the DIFFUSION and FLAIR sequences is crucial as it will directly contribute to the therapeutic decision. A FLAIR-diffusion mismatch, i.e., a lesion with a diffusion but not a FLAIR hypersignal, identifies patients whose time of onset of symptoms is probably less than 4.5 hours. It is therefore understandable that the main arterial recanalization techniques performed in the acute phase are primarily reserved for patients with a positive mismatch. In current practice, mismatch assessment is performed subjectively, by visually comparing the two sequences, which is known to be the cause of a lack of reproducibility and diagnostic performance. Computational medical imaging techniques ("radiomics") have recently gained momentum and offer the prospect of automated and therefore more reproducible analysis of medical imaging data. In stroke patients, radiomics extracted from FLAIR imaging could thus contribute to describe the "diffusion flair" mismatch in a continuous and objective way. For the time being, data analysis cannot be performed in real time due to technical constraints. If it is proven that radiomics can reliably analyze the mismatch on the FLAIR sequence alone, the next step will be to make the analysis feasible in clinical routine (i.e. in a time frame adapted to the therapeutic management).