2,235 Clinical Trials for Various Conditions
This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic neuropathy-Plus (LHON-Plus) participants will undergo simultaneous enrollment in two disease-based arms and receive daily oral doses of glycerol tributyrate to assess its safety and potential for efficacy using clinical, biochemical, and molecular evidence. This study will utilize a two-month baseline lead-in phase to establish and document the clinical baseline for each participant in both arms in order to compare the molecular and clinical parameters. This is clinically relevant in light of the high clinical heterogeneity among subjects affected by the same mitochondrial disease (MELAS or LHON-Plus). For ethical concerns prompted by the lack of treatment for these two intractable and progressive mitochondrial diseases, there will not be a placebo control group. Thus, each participant will act as their own control and receive oral doses of glycerol tributyrate, eliminating the need for a placebo. Considering the high clinical heterogeneity among participants affected by MELAS or LHON-Plus and some clinical divergence between MELAS and LHON-Plus, this strategy is beneficial to every enrolled participants, as each will receive the investigational drug, glycerol tributyrate. In addition, this approach will determine the subject-specific maximal optimized dose in a personalized medicine-based approach. After approval of the IRB protocol from the Institutional Review Board Data and signed consent form from all participants, this investigational basket clinical trial has three phases spanning over 20 months: * A baseline lead-in phase (2 months) to collect participant-specific baseline for clinical, biochemical, molecular and metabolic biomarkers that will be monitored throughout the subsequent dose-escalation and clinical phases. * A dose-escalation phase (6 months) to determine the participant-specific maximum tolerated dose (MTD) during which participant-specific clinical and biochemical biomarkers are collected every month. * A clinical phase at a fixed subject-specific MTD dose (12 months) to collect participant-specific clinical, biochemical, molecular and metabolic biomarkers and to perform three scheduled skin biopsies: at the outset, mid-point, and the end of this clinucal phase. We have planned for a 12-month-long clinical phase at a fixed participant-specific MTD considering the absence of reliable predictors that makes idiosyncratic disease-specific symptoms for MELAS and LHON-Plus impossible to forecast among participant for assessing the potential efficacy of glycerol tributyrate by monitoring clinical symptoms specific for each disease. During the 12-month-long time-frame, disease-specific clinical symptoms will be collected as preliminary evidence of efficacy of glycerol tributyrate using disease-specific biomarkers. Finally, discharge procedure during which the clinical investigator will record non-serious adverse events or serious adverse events for 7 or 30 days, respectively, after the last day of study participation.
The purpose of this study is to evaluate the sensitivity and specificity of the video head impulse test (vHIT) device, when implemented in the acute ED setting to identify acute ischemic stroke or central pathology vs peripheral vestibular dysfunction in patient's presenting with vertigo. This study will evaluate the implementation of the device, consistency with current diagnostic standards, unnecessary administration of antithrombolytics and will further study the reduction in hospital admissions and overall healthcare costs.
Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.
Stroke-like migraine attacks after radiation therapy-also known as SMART syndrome-constitute a rare condition typically characterized by headache, seizures, vision abnormalities, hemiparesis, and aphasia. The condition usually resolves within a few days or weeks of onset with no residual impairments. However, resolution in some cases extends over a period of months rather than weeks and may be incomplete. The purpose of this case report is to provide an in-depth description of the progression of changes in cognitive and language functioning for a person exhibiting SMART syndrome characterized by slow recovery.
To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their hand in supplementation with conventional occupational therapy to assess whether it improves motor function and speed recovery during inpatient rehabilitation versus conventional occupational therapy alone. Also, what impact does this have on quality of life.
Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground. The investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.
This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).
The purpose of this study is to compare the efficacy of two (2) different doses of idebenone with that of a placebo over a one month period on cerebral lactate concentration as measured by magnetic resonance spectroscopy.
The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction.
Individuals with chronic stroke have long-term walking problems that limit community engagement and quality of life, lead to secondary disabilities, and increase healthcare costs and burden. These walking issues often persist despite rehabilitation. One novel target for stroke gait rehabilitation is interlimb coordination-the phase-dependent cyclical relation of the legs. Interlimb coordination is altered during walking after stroke, compromising walking stability, phase transitions, and responses to perturbation and contributing to motor compensation. It is unclear what neural pathways contribute to impaired interlimb coordination after stroke and what impact this has on walking-related outcomes. This proposal consists of two aims to address these issues, with the long-term goal of developing therapeutic interventions to improve interlimb coordination and walking after stroke. Aim 1 will identify which neural sources contribute to impaired interlimb coordination after stroke. During bilateral, cyclical recumbent stepping (analogue of walking), interlimb coordination will be assessed as relative leg phasing. During the task, transcranial magnetic stimulation and peripheral nerve stimulation will be applied to assess supraspinal, interhemispheric, spinal interneuronal, and sensory pathways. The relation of interlimb coordination with these outcomes will be assessed to determine potential contributors. Aim 2 will test the association between interlimb coordination and walking after stroke. Interlimb coordination will be quantified during split-belt treadmill walking, and associations with walking speed, endurance, mobility, independence, daily activity, quality of life, and community engagement will be tested. An additional exploratory aim will determine the effect of targeted neuromodulation on lower limb interlimb coordination. Electrical stimulation will be applied to three locations in a cross-over study: the primary motor cortex (supraspinal/interhemispheric), thoracolumbar spine (spinal interneuronal), and peripheral nerves (sensory).
The DONE SYMPLE Trial is a global clinical study testing whether a procedure called endovascular therapy, which removes blood clots from blocked brain arteries, can safely benefit more stroke patients when used up to 72 hours after symptoms begin. Endovacular Therapy is already proven to improve recovery in patients treated within 6 hours, but only when advanced imaging like Computed Tomography (CT) perfusion or Magnetic Resonance Imaging (MRI) is available to guide treatment. Unfortunately, many hospitals, specially in underserved areas, do not have access to this type of imaging. This trial will investigate whether a basic brain scan called non-contrast CT, which is widely available in hospitals around the world, can be used instead. Special software will automatically analyze the CT scan to help doctors decide if a patient has enough brain tissue left to save with Endovascular Therapy. If this simpler approach works, it could expand access to lifesaving stroke care for more people globally. The study will enroll 500 adult stroke patients, ages 18 to 80, with a large vessel blockage in the brain's anterior circulation, moderate to severe stroke symptoms, and who are between 6 and 72 hours from when they were last known to be well. All participants will undergo CT imaging analyzed by the automated software. If the scan shows a small core of already damaged brain tissue and a larger area of threatened but still viable brain, the patient will qualify. Participants will be randomly assigned to receive either standard medical therapy alone or medical therapy plus Endovasculat Therapy which involves inserting a catheter through a blood vessel to reach the brain and using a device to remove the clot. This procedure is performed by trained stroke or neurointerventional specialists. The study is "open-label," meaning patients and doctors know which treatment is given, but the assessment of patient recovery will be done by independent reviewers who do not know the group assignments. The primary goal is to determine if patients who receive Endovascular Therapy have better recovery at 90 days, measured by a scale called the modified Rankin Scale, which assesses how much disability a patient has after a stroke. The trial will also look at safety (especially brain bleeding after treatment), size and growth of brain injury on follow-up scans, recovery of strength and language, and overall quality of life and survival. Imaging will be reviewed centrally by a specialized team, and results will be analyzed to see how well Endovascular Therapy performs using this new patient selection method. The DONE SYMPLE Trial is sponsored by the University of Iowa in collaboration with the University of Texas Health Science Center in Houston. It will take place at up to 20 hospitals worldwide. All patients will be followed closely with exams and imaging at specific time points up to 90 days after treatment. If successful, this trial could change stroke care around the world by proving that Endovascular Therapy can be used safely and effectively even without advanced imaging, using tools available in most hospitals. This could help more stroke patients, especially in rural or resource-limited areas, access treatments that may improve their chances of recovery and reduce long-term disability.
The goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. The mains questions it aims to answer are: * To determine the extent to which this combined treatment can improve language. * To determine the extent to which the combined treatment can improve arm movements. Researchers will compare the effects of this combined treatment with treatment that targets arm movements alone.
The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available. EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.
The investigator proposes to examine the effects of excitatory transcranial magnetic stimulation (TMS) combined with semantic feature analysis (SFA) language therapy to improve word-finding abilities in stroke survivors with aphasia (SWA).
What is United4Stroke (U4S)? United4Stroke is a research program at the University of Texas at El Paso (UTEP) that aims to help stroke survivors become more active and reduce sedentary time through education, movement, and personalized coaching. Where Does It Happen? All sessions take place at: UTEP's Rehabilitation Sciences Complex located at 3333 North Mesa Street, El Paso, TX 79902 What is Involved? The program includes 12 total visits over several months: * 8 group sessions (held every two weeks) * 4 individual evaluation visits (before, during, and after the program) Who Can Participate? * Individuals 18 years of age or older who have had a stroke at least 6 months prior to joining the study. * Family caregivers may also join What Happens During the Visits? First Visit: * Learn about the study and give consent * Answer questions about memory, movement, general health, and daily activity * Do walking and mobility tests * Get fitted with a small movement sensor (ActivPAL) and a Fitbit Group Sessions (Visits 2-8): * Topics: physical activity, sitting less, balance and falls, and activities of daily living * Led by UTEP physical therapy faculty * Includes group discussions and hands-on activities * Some participants will also get one-on-one coaching to help with physical activity engagement, daily step count, and reducing sedentary behavior. Follow-Up Visits (Visits 9 and 11): * Repeat earlier tests to check progress * Share feedback about the program Final Visit (Visit 10): * Celebrate progress! * Social gathering, certificates, and a presentation of results Goal: To support stroke survivors in becoming more active and living healthier, more independent lives-step by step.
CERES-TANDEM is a multicenter study designed to improve the understanding of "tandem" ischemic stroke -those caused by two blockages in series, one in a neck artery and one in a brain artery-. Because tandem occlusion-related stroke tend to cause more severe brain injury and have been under-represented in major clinical trials, there is no clear consensus on which treatments work best. This study will help identify who is most at risk and which therapies lead to the best recovery. OBJECTIVES: Identify Risk Factors: Compare common stroke risk factors (e.g., high blood pressure, diabetes, high cholesterol, smoking) in patients with tandem occlusion versus those with single-site large vessel occlusions. Compare Clinical Outcomes of Reperfusion: Evaluate whether acute reperfusion treatments-such as clot-dissolving drugs (thrombolysis), mechanical clot removal (thrombectomy), and emergent carotid stenting-lead to better 3-month functional outcome (assessed by the modified Rankin Scale, ranging 0 to 6, with good functional outcome identified with mRS score 0-2) compared to medical management alone in tandem occlusion and isolated cervical artery occlusion. Assess Post Stent Therapy: Among patients who receive emergent stenting, determine whether different post-stenting regimens (antiplatelet agents, anticoagulants, or no additional therapy) affect functional outcomes, bleeding events, or stroke recurrence. STUDY DESIGN: Type: cohort study pooling data from prospective registries of cerebrovascular diseases at participating sites Setting: Stroke Unit, Cesena Hospital (PI MR), Interventional Neuroradiology, Vall d'Hebron Research Institute, Barcelona (PI FD), Radiology, Boston Medical Center (PI TN); and other participating stroke centers Time Frame: Patients treated between 2018 and 2024. Sample Size: Approximately 2800 cases overall DATA COLLECTION: Sources: Clinical records, imaging reports (CT perfusion, angiograms), lab results, hospital discharge summaries, and longitudinale stroke registry databases. Data Safety: case information is anonymized using encrypted study IDs; only aggregate data will be reported. Follow-Up: Standard-of-care follow-up visits at 3 months (minimum) and up to 12 months or until death. Outcomes include functional status (mRS), recurrence of stroke or TIA, symptomatic intracranial hemorrhage, major bleeding, and all-cause mortality OUTCOMES AND ANALYSIS: Primary Outcome: Functional outcome, identified by the mRS and tested between groups with ordinal shift between mRS categories (0-6). Secondary Outcomes: functional status at 3 months (excellent outcome mRS 0-1, good outcome mRS 0-2) Additional outcomes: early neurological deterioration; symptomatic intracerebral hemorrhage and successful recanalization (defined as TICI 2b or higher). PLANNED ANALYSIS (see Detailed Description for full analytical protocol): * Compare outcomes in emergent stenting vs no stenting groups depending on stent subtype and endovascular approach * Compare outcomes in emergent stenting vs no stenting groups depending on antithrombotic treatment before, during and after the endovascular procedure * Define the potential impact of early statin treatment on the interplay between stenting vs no stenting and the outcomes. STATISTICS: Medians with IQRs and means with SDs together with percentages will be used to present the distribution of ordinal, continuous, and categorical variables. Baseline characteristics across groups will be compared using the Pearson χ2 test for categorical variables and t test or the Kruskal-Wallis test, as appropriate, for continuous and ordinal variables. Given the nature of data deriving from prospective registries, inverse probability of treatment weighting (IPTW) will be implemented, which is an application of propensity scores that calculates the probability of being exposed to one treatment versus the other and creates a pseudo-population based on the probabilities so that potential confounders are equally distributed across the treatment groups. Models will be weighted for prespecified variables known to potentially impact the outcome, and will also consider factors of imbalance between groups. In case of crossovers, a stratum-based analysis according to predefined estimand will be applied (direct intervention effect on outcomes and total-effect; estimand approach in detailed description). DISSEMINATION The results will be disseminated in international peer reviewed journals. CERES-TANDEM is promoted by * Bufalini Stroke Center, AUSL Romagna, Cesena, Italy (PI Dr. M. Romoli) * Interventional Neuroradiology Unit, Vall d'Hebron Institut de Recerca, Barcelona, Spain (PI Dr. F. Diana) * Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts, USA (PI Dr. T. Nguyen)
The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).
Rupture of vulnerable carotid, vertebral, and intracranial arterial plaques results in thromboembolic stroke. Identification of these culprit lesions is an important component of post-stroke care. This study seeks to test the feasibility of NaF PET-CT to detect these plaques and alter patient care. Prior studies have shown a high degree of correlation between NaF PET+ lesions and high-risk plaque features on high resolution MRI, including mirocalcification, necrosis, and ulceration.
This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.
The purpose of this research study is to explore whether genetic testing can offer a personalized and timely approach to assist physicians in making more informed medication decisions for stroke or high-risk transient ischemic attack (TIA) patients during their hospital stay.
This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Before this therapy, the participants will get structural brain imaging. Functional brain imaging will be performed before and after the study's completion to measure brain activity response to therapy. The purpose of this research study is to evaluate patients who have had a stroke between 6 and 24 months ago with a visual field impairment. The duration of active participation in the study is 1.5 months.
The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).
To determine changes in power symmetry, gait symmetry, and functional outcomes for participants' poststroke (Inpatient Rehabilitation Facility) after participating in an intervention using a recumbent cycle with power biofeedback (BFB). To determine how this intervention can impact gait asymmetry, a common disorder poststroke secondary to hemiparesis. Gait asymmetry is a difficult impairment to treat because it is difficult for both therapists and patients to perceive. Training with BFB allows for quantitative data about the power production or lack of that directly impacts safety in walking, increased energy expenditure, and decreased gait speed.
This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component). Participants will be randomly assigned to one of two groups: * Experimental Group (EG): Robotic-assisted upper limb rehabilitation combined with conventional therapy. * Control Group (CG): Conventional therapy alone including upper limb rehabilitation. Clinical assessments will be conducted at baseline (T1), post-treatment (T2), and at a 3-month follow-up (T3) using remotely administered scales. Secondary objectives include evaluating improvements in muscle strength, range of motion, eye-hand coordination, manual dexterity, and functional independence. The study will also assess prognostic factors influencing response to robotic therapy, patient satisfaction, and potential adverse events.
The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.
In this pilot safety study, the investigators will give a second dose of Intravenous Tenecteplase (IV TNK) to patients receiving the initial TNK dose within 3 hrs of last known normal (LKN), have a baseline National Institutes of Health Stroke Scale (NIHSS) \> 6, and who do not clinically improve within 45 minutes of the first dose, or who improve but then deteriorate, and can still be treated within 4.5 hours from LKN. Patients will require a second computed tomography (CT) scan to rule out any bleeding, and meet the usual inclusion and exclusion criteria for TNK treatment, before the second dose which must be given within 4.5 hrs of LKN. Both TNK doses will be 0.25 mg/kg. The initial TNK dose may be given on the Mobile Stroke Unit (MSU) or Emergency Department (ED), and the second dose in the ED. Informed consent will be obtained before the second dose is given. The primary outcome will be symptomatic intracranial hemorrhage (sICH) (SITS-MOST criteria) or serious systemic bleeding within 36 hours. Secondary outcomes will be any intracranial hemorrhage, any bleeding, discharge NIHSS and modified Rankin Score (mRS), and mRS at 90 days (sliding dichotomy). 20 patients will be enrolled. Enrollment will be stopped if more than 3 sICH occur (\> 80% confidence that sICH rate is \> 5%. If successful, this study will be followed by a larger phase 2b controlled safety confirmation and pilot efficacy study,
The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in subacute stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
The goal of this observational study is to establish a prospective multicenter registry of patients undergoing intracranial stenting for ischemic strokes caused by medically refractory ICAD. The study aims to evaluate current practice patterns, periprocedural outcomes, and delayed outcomes. Researchers will collect demographic and procedural data from patients who undergo intracranial stenting after having an ischemic stroke caused by medically refractory ICAD.
The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (\>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is: Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living? The study is designed so each participant serves as their own control. Researchers will compare information from the baseline, intervention, and retention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm. Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.