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Stroke clinical trials

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NCT ID: NCT03827187 Recruiting - Stroke Clinical Trials

Awareness Detection and Communication in Disorders of Consciousness

Start date: February 8, 2022
Phase: N/A
Study type: Interventional

STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.

NCT ID: NCT03826875 Recruiting - Depression Clinical Trials

Poststroke Depression in Hemorrhagic Stroke

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

NCT ID: NCT03826030 Recruiting - Stroke, Ischemic Clinical Trials

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

TRANSPORT 2
Start date: September 1, 2019
Phase: Phase 2
Study type: Interventional

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

NCT ID: NCT03821883 Recruiting - Stroke Clinical Trials

Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation

ASPIRIN-LAAO
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO). Patients diagnosed with atrial fibrillation and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment. The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

NCT ID: NCT03821129 Recruiting - Stroke Clinical Trials

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

REDUCE PAS
Start date: July 25, 2019
Phase: N/A
Study type: Interventional

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

NCT ID: NCT03820843 Recruiting - Clinical trials for Ischemic or Hemorrhagic Stroke

Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia

ART-CONNECT
Start date: February 17, 2020
Phase: N/A
Study type: Interventional

A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.

NCT ID: NCT03820375 Recruiting - Clinical trials for Embolic Stroke of Undetermined Source

Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke

Catch-up-ESUS
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Up to know, there is no clear diagnostic and therapeutic pathway for patients with embolic stroke of undetermined source (ESUS). This prospective registry study, which follows up adult ESUS patients for 36 months, is intended to provide important data for the detection of an individual approach in ESUS patients based on a structured diagnostic and therapeutic pathway.

NCT ID: NCT03817385 Recruiting - Stroke Clinical Trials

rTMS and Robotic Gait Training in Patients With Stroke

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Patients with stroke have demonstrated abnormal muscle tone and postural control ability which affect their ambulation, activity of daily living and confident. Nowadays, utilizing repetitive transcranial magnetic stimulation (rTMS) and robotic machines to assist walking training for stroke patients has been applied to clinic widely. While less studies have compared intervention efficacy for stroke patients between rTMS and robotic training. This study aimed to compare effect of rTMS and robotic training for lower-extremity function and gait in stroke patients.

NCT ID: NCT03816865 Recruiting - Stroke Clinical Trials

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

NOR-FIB2
Start date: March 1, 2018
Phase:
Study type: Observational

Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion. Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic lesions after programmed direct-current cardioversion using diffusion-weighted sequences in brain MRI (DWMRI). Secondary Objectives: To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF. To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF. To assess cognitive and cerebral structural and metabolic changes after direct-current cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before and 12 months after treatment. Number of Subjects: 50 Study Centers: Østfold Hospital Trust Duration of Study Participation: - Enrollment: 18 months - Follow-up period: 12 months - Total Study Duration: 30 months Primary Endpoints: • Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. Secondary Endpoints: - Rate of AF recurrence within 1 year after direct current cardioversion - Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up - Change in levels of fibrosis biomarkers from baseline to 12 months follow-up - Cognitive function at 12 months follow-up - Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up - Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up - Brain volume at 12 months follow-up - White matter volume 12 months follow-up - Grey matter volume 12 months follow-up - Cortical volume 12 months follow-up - RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion coefficient, extracellular water fraction, fractional anisotropy; free water fraction; intracranial volume; NAWM: normal appearing white matter; neurite density; RSI: restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted fractional anisotropy; white matter lesions.

NCT ID: NCT03816059 Recruiting - Stroke Clinical Trials

Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications

Start date: February 12, 2019
Phase:
Study type: Observational

Respiratory virus infections are one of the major causes of hospitalizations, and outbreaks of respiratory virus infection have led to severe economic loss. In addition to pulmonary complications, respiratory viruses can also lead to non-pulmonary complications. However, many previous studies on the complications of respiratory viruses are retrospective in nature, and therefore many patients with respiratory virus infection may not be tested. Furthermore, these studies did not take into account that respiratory viruses can be found in some asymptomatic individuals. The aim of this study is to capture the burden of respiratory viruses in patients with acute pulmonary and extrapulmonary complications. We will recruit patients admitted to our hospital with acute coronary syndrome, stroke and exacerbation of underlying lung diseases. We will collect saliva from these patients and test for respiratory viruses. As controls, we will recruit asymptomatic patients at the out-patient clinic for follow up of chronic heart, lung or neurological diseases. We anticipate that this study will greatly enhance our understanding of the epidemiology of respiratory viruses in acutely hospitalized patients. Our findings will be important for clinicians, public health practitioners and scientists.