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Stroke clinical trials

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NCT ID: NCT05051488 Not yet recruiting - Brain Tumor Clinical Trials

Dynamic Decompressive Craniotomy

Start date: September 30, 2021
Phase:
Study type: Observational

Prospective observational study on patients undergoing decompressive craniotomy

NCT ID: NCT05051397 Not yet recruiting - Anesthesia, General Clinical Trials

CO2 Modulation in Endovascular Thrombectomy for Acute Ischemic Stroke

COMET-AIS
Start date: October 2, 2021
Phase: Phase 2
Study type: Interventional

Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.

NCT ID: NCT05051111 Not yet recruiting - Stroke Clinical Trials

Pre-stroke Physical Activity in Patients With Stroke

Start date: September 2021
Phase:
Study type: Observational

The aim of this study is to explore the level of pre-stroke physical activity in patients with stroke and to investigate associations between physical activity and sociodemographic variables, e.g. history of stroke, co-morbidities and subtype of stroke. Physical inactivity is a great risk factor for stroke; thus, the investigators hypothesise that patients hospitalised with stroke will present with a lower level of pre-stroke physical activity than recommended by World Health Organization (WHO) guidelines on physical activity for health. Additionally, the investigators expect to find an association between pre-stroke physical activity and specific sociodemographic variables, e.g. stroke subtype, and re-stroke.

NCT ID: NCT05049109 Not yet recruiting - Blood Pressure Clinical Trials

Integrated Telehealth After Stroke Care

iTASC
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

In this pilot trial, the investigator will compare early post-stroke BP management using an integrated Telehealth After Stroke Care (iTASC), to usual care with a primary outcome of BP control defined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes. As this is a preliminary trial with a small sample, estimates derived will be used to plan the subsequent larger confirmatory trial. Descriptive statistics will characterize the randomized patients completing surveys and outcome assessments. The study will evaluate the primary clinical outcome (BP <140/90 mmHg) 90 days post-discharge as a function of treatment and adjusted for from baseline BP. Change from baseline BP will also be assessed as an outcome. Change in activity level and duration, as well as trends in sedentary time will be compared between arms, and pre- and post-intervention with visual tailored infographics in the intervention arm. Moderating effects of demographics will also be evaluated. Decisions regarding the pursuit of a subsequent trial will use the primary outcome, and analysis of all other measures will be hypothesis generating.

NCT ID: NCT05046574 Not yet recruiting - Hemorrhagic Stroke Clinical Trials

A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation

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

The investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical treatment for patients currently enrolled in the Mayo Clinic Stroke Rehabilitation Unit.

NCT ID: NCT05046106 Not yet recruiting - Stroke Clinical Trials

MLC1501 Study Assessing Efficacy in STROke Recovery

MAEStro
Start date: January 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-dose twice a day, or matching placebo for 24 weeks.

NCT ID: NCT05044507 Not yet recruiting - Ischemic Stroke Clinical Trials

The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study

Start date: September 2021
Phase: N/A
Study type: Interventional

This is a multicenter study that will be conducted at up to 20 inpatient rehabilitation facilities (IRFs) in the United States. BQ 2.0 is a wearable medical device that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. In this study, BQ 2.0 is intended to reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment. BQ 2.0 will be used for 9 weeks in conjunction with physical and occupational therapy (PT/OT), with treatment initiated in inpatient rehabilitation facilities (IRF) and then continued post-discharge in subjects' homes under periodic remote supervision of a trained site study team member. The study will enroll up to 150 subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.

NCT ID: NCT05041582 Not yet recruiting - Stroke Clinical Trials

SSRIs and TDCS Enhance Post-stroke Motor Recovery

Start date: September 1, 2021
Phase: Phase 3
Study type: Interventional

Post-stroke motor recovery is compelling but limited. Current rehabilitation has less impacts on the plateau that spontaneous biological recovery could be expected. The advances in non-invasive neuromodulation and neurophysiological characterization of critical motor recovery period enable breaking the proportional recovery limitation. Our pilot studies demonstrated the safety and responsiveness of combing dual transcranial direct current stimulation (tDCS) and motor training in subacute stroke patients. There is also strong evidence that selective serotonin reuptake inhibitors (SSRIs) can substantially increase the effects of tDCS and improve motor function after stroke, even in the absence of depression. This proposal aims to prove the potential of combining of tDCS and the commonly used SSRI citalopram to improve response to a daily motor training intervention in acute stroke patients (Co-STARS trial).

NCT ID: NCT05041010 Not yet recruiting - Ischemic Stroke Clinical Trials

Rescues On Reperfusion Damage In Cerebral Infarction by Nelonemdaz

RODIN
Start date: September 2021
Phase: Phase 3
Study type: Interventional

Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute ischemic stroke patients receiving endovascular treatment to remove clot within 12 hours following stroke onset. Neu2000KWL will be administered before endovascular treatment.

NCT ID: NCT05039047 Not yet recruiting - Stroke Clinical Trials

External Validation of Two Prediction Models for Independent Gait After Stroke

REPEAT
Start date: October 2021
Phase:
Study type: Observational

Regaining independent gait is one of the main goals in stroke rehabilitation and early prediction of gait outcome is important to guide discharge planning at acute stroke units, design rehabilitation and inform patients and relatives. In the last decade, two easy-to-apply prediction models for gait were developed: the EPOS model in the Netherlands and the TWIST model in New Zealand. Although the models' performance in the development cohorts was good, this does not automatically mean that the models are ready for application in clinical practice, as it is unknown whether their performance is also good in an independent cohort from a different country and with different patient characteristics. Such external validation is an essential step towards clinical implementation of prediction models. A mobility-related problem is the occurrence of falls after stroke. Walking is among the Top 3 activities during which stroke patients fall, with the other two activities being transferring or sitting in a wheelchair. Especially soft tissue injuries after a fall are common and in 1-15% of the patients, the fall results in a fracture. Apart from the costs that arise from these injuries, falls have a negative impact on the patient's physical functioning and psychological status, with an increased dependency and fear of falling, resulting in a reduced quality of life. A systematic review found 12 studies that developed fall risk prediction models for either inpatient rehabilitation stroke patients or those living in the community. Important predictors for falls are the presence of hemi-inattention, fall history and balance deficits. However, none of the models had an acceptable performance and predictors were not always captured by a validated assessment, which is an important prerequisite for an unbiased prediction model. The primary aim of this study is to externally validate the EPOS and TWIST models for independent gait after stroke in a heterogeneous sample of subjects admitted to the hospital with an acute stroke. It is hypothesized that the performance of both models in this independent cohort will be lower than in the development cohorts, but still be adequate. The secondary objective is to investigate the occurrence and predictability of falls within the first six months after stroke and its relationship with the prognosis for independent gait within this sample.