Vascular Dementia
Explore ongoing vascular dementia research studies. Find trials that comply with HIPAA and IRB standards.
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Found 1214 Actively Recruiting clinical trials
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Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings despite the increasing rates of patient cognitive complaints and the availability of numerous cognitive assessment tools. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. This problem is more prevalent among older African-Americans and Hispanics than older whites, and more common in rural than urban populations. The investigators developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes \<5 minutes, does not require informants, and accounts for major technical, cultural, and logistical barriers of current assessments. The investigators are conducting a simple randomized clinical trial to examine the clinical efficacy of the 5-Cog paradigm (5-Cog brief cognitive assessment paired with a clinical decision-making tool) to improve dementia care in 1,200 predominantly minority sample of older adults with cognitive concerns presenting to a primary care clinic in the Bronx. Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved dementia care actions by primary care physicians compared to an active control arm. Following up on these very promising results, the investigators propose a hybrid Type 1 effectiveness-implementation design in real-world settings to adapt and test the effectiveness of the 5-Cog paradigm to increase detection of cognitive impairment care in older adults presenting with cognitive concerns. The aim of the pragmatic cluster-randomized trial is to test the clinical effectiveness of the 5-Cog paradigm in increasing cognitive impairment detection and improving dementia care - ascertained via electronic medical record. Randomization will be at the clinic level, and select 22 primary care practices; 6 in Bronx and 18 in urban and rural Indiana. 300 participants per practice will be enrolled for a total of 6,600 older patients with cognitive concerns. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations. Outcomes are new cognitive impairment diagnoses (primary) and improved dementia care (secondary) in the 90-day period following presentation of cognitive concern to the primary care physician. * New cognitive impairment diagnoses (primary): New diagnosis of dementia or Mild Cognitive Impairment by primary care physicians. For patients with a previous diagnosis of Mild Cognitive Impairment in electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome. * Improved dementia care (secondary): Any of the following: 1. Tests ordered for reversible causes of cognitive impairment as per published guidelines. 2. New cognitive enhancing medication prescriptions or deprescribing anti-cholinergic. 3. Referral for cognitive/dementia evaluation by specialists (Neurology, Geriatrics, Psychiatry). 4. Referral to social worker or community-based organizations. Implementation issues and cost-effectiveness of the 5-Cog paradigm will also be examined. This proposed study focuses on scalable approaches to address the unmet need of early detection of incident cognitive impairment, including in populations that experience health disparities.
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Healthy Volunteer
Stroke is the leading cause of enduring disability worldwide, contributing to widespread impairments in survivors, thereby impeding various activities of daily life. Despite the effectiveness of intensive inpatient rehabilitation in mitigating deficits and activity limitations, maintaining an optimal treatment dose for patients transitioning to home remains a challenge. To address this gap, the integration of caregivers into home-based, evidence-supported rehabilitation emerges as a promising approach, yet its efficacy requires comprehensive examination. This clinical trial aims to assess the efficacy of a newly developed intervention, caregiver-assisted rehabilitation with strategy training (CAR-ST), in enhancing the activity performance of stroke survivors. A single-blinded, three-arm randomized controlled trial will be executed, comparing the efficacy of the CAR-ST intervention against strategy training alone or attentional control through education. A procedure of randomization with minimization will be conducted by a researcher who is independent of the investigation and outcome assessments. Eligible stroke survivors and their caregivers will be recruited from collaborative hospitals in Northern Taiwan and randomly assigned with even possibility. Longitudinal evaluations will be conducted at baseline (T1), post-intervention (T2), 3-month (T3), and 6-month (T4) follow-ups, utilizing the Activity Measure for Post-Acute Care (AM-PAC) outpatient shortform as the primary outcome. Secondary outcomes will include the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), EuroQol-5D (EQ-5D), Stroke Self-Efficacy Questionnaires (SSEQ), Fugl-Meyer Assessment (FMA), Montreal Cognitive Assessment (MoCA), and Goal Attainment Scaling (GAS). Under the principles of modified intention-to-treat, quantitative data will be analyzed using multiple linear regression models and mixed-effects regression models. If data is lost at follow-up, inferential statistical analyses for group comparisons will be conducted both with or without multiple imputation. Furthermore, qualitative in-depth interviews with participants, caregivers, and therapists will be conducted post-intervention. These interviews will explore experiences, satisfaction, and perceived effectiveness of the intervention. Transcribed data will undergo coding by two independent coders and subsequent analysis through the thematic analysis method.
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Healthy Volunteer
The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Adult stroke patients with upper extremity motor impairments (henceforth "experimental group"), healthy controls, and participants with risk factors for stroke, without upper extremity impairment (allowing them to serve as controls for patients with upper extremity impairments (henceforth "control group")), will be recruited in this study. Half of the participants in the experimental group will be randomly assigned to the EEG-BCI (brain-computer interface) training ("closed-loop") group and will receive training on the BCI task along with muscle and tongue stimulation. The other half of the participants in the experimental group receiving traditional rehab will not receive any kind of FES or tongue stimulation for the first 8-10 weeks of study period and then will start receiving BCI-FES-tongue stimulation rehab therapy. All participants without UE impairment in Control group 1 will receive 4-6 (minimum 4, up to a maximum of 6) sessions of training on the BCI system and pre- and post MRI and 2 behavioral testing sessions. Addition of a Control group 2 is consistent with the AHA grants - Twenty four ischemic stroke patients with moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45); no upper extremity injury or conditions that limited use prior to the stroke; and pre-stroke independence with a Modified Rankin Score of 0 or 1), will be recruited in this arm. All participants in this group will receive MR sessions and behavioral testing similar to the Experimental group. Addition of an Experimental group receiving EEG-BCI-bilateral FES intervention using the recoveriX system: recoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. Through the EEG-based recoveriX BCI system, the brain receives visual and tactile feedback in real-time, making rehabilitation more effective. A stroke patient imagines a hand movement while receiving visual feedback through a virtual avatar, and tactile feedback through electrical muscle stimulation paired to the patient's imagined movement, with the aim that these patients might regain the volitional ability to grasp following therapy. Unlike the current EEG-BCI-FES intervention that involves stimulation of only the impaired arm, with recoveriX, both arms are simultaneously stimulated during the course of the intervention. Specific Aims To determine if functional muscle stimulation of the arms, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery as measured by behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Primary objective * To examine the effect of EEG guided functional muscle stimulation on improvement in upper extremity function Secondary objective * To examine plasticity changes as measured by EEG/fMRI measures before and after EEG guided functional muscle stimulation.
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Post-stroke depression with executive dysfunction (DED) is associated with persistent mood and cognitive disturbance, poor social functioning, and disability. Existing interventions have limited evidence of efficacy, side effects, and can be difficult for stroke patients to access. This study aims to evaluate a remote digital intervention for post-stroke DED that combines iPad-based cognitive training using a program called AKL-T01 with virtual coaching to improve executive dysfunction, depression, and daily function after stroke. The primary hypothesis is that individuals randomized to the intervention arm (AKL-T01 + coaching) will demonstrate greater improvement in their executive functioning and depression symptoms and daily function relative to the comparator arm. The secondary hypothesis is that individuals randomized to the intervention arm will demonstrate greater increase in the functional connectivity of the executive control network (ECN, assessed with an MRI scan) at the conclusion of treatment, relative to participants randomized to the comparator arm.
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Healthy Volunteer
Person-centred care can be supported when healthcare professionals access and actively use the information recorded in a life story. Active use of the life story can create security for a person with dementia and their carers. The written life story describes the person and their life experiences, which can define the person's identity. National guidelines for care and nursing in dementia and Blekinge's regional guidelines emphasise the importance of care and nursing for people with dementia, which should be given with a person-centred approach, where the life story becomes a tool for healthcare professionals. Research shows that a life story can be designed in several ways. For example, in book form, as a brochure, collage, memory box or electronically. The life story is also intended as a tool for healthcare professionals to create security and facilitate communication with the individual. As more and more older adults are using computers and tablets as assistive devices, and it is also becoming more common for healthcare professionals to use, for example, tablets as assistive devices in nursing care, the life story could be shared in digital form as an application and become a living document. Overall aim: To test an application for the life story with the intention of supporting person-centred care for older adults with dementia and to test whether the application can replace the written completion document. Study I: Exploring the research area of the life story in digital form. Study II: Focus group interviews with healthcare professionals. Study III: Test the application, Min Memoria. Study IV: Observations on the use of the application.
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The goal of this clinical trial is to investigate the effectiveness of the developed application and exoskeleton robot devices for home-based training in stroke patients and patients with spinal cord injuries. The application that uses an Internet of Things (IoT) platform to enable remote monitoring of rehabilitation progress by clinical practitioners. Simultaneously, it seeks to assist the execution of patient movements through devices. In patients with stroke, half of the participants will be assigned to experimental group, receiving a smart upper limb motor rehabilitation system for home program. The other half will be assigned to control group, receiving a traditional home program. In patients with spinal cord injuries. Participants will follow the same allocation method for home-based intervention. Researchers will conduct an analysis before and after intervention, examining progress in motor function, activities of daily living, and quality of life.
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After the selected patients are determined, the researchers of this study need to have full communication with the patients. The location is the rehabilitation ward of our hospital and the time is Before joining the group. During this process, the patient should be informed of the purpose, procedures and processes of the trial. The informed consent form should be signed by the patient himself/herself. Such as the patient Illiterate, the informed consent process was witnessed by an independent witness and signed. The subject pressed their fingerprint at the signature. In the study process fully Listen to and respond to the questions and opinions of the subjects or their representatives.
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Healthy Volunteer
The current study is a mechanistic study to evaluate working memory gains with transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control. This study is funded by a mentored career award (The University of Florida, Clinical and Translational Science Institute \[CTSI\] Pilot Award) and thus the mentors (Drs. Cohen, DeKosky, Woods, Fang) are listed as additional Principal Investigators in this study. The proposed study investigates the effects of acute (one-time) tDCS application on working memory gains (i.e., behavior and functional) by evaluating brain structure and cognitive function relationships. tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. A mechanistic, in-scanner, crossover design tDCS study (active and sham stimulation) with 2milliamps (mA) fixed dosing application will enroll 110 participants comprising 55 cognitively normal/healthy older adults and 55 older adults with MCI. The study will employ multi-modal neuroimaging (structural and functional data), person-specific computational models, and machine learning to elucidate acute tDCS effects on working memory. Change in cognitive function (i.e., working memory performance) will be quantified using working memory tasks and magnetic resonance imaging (MRI). The investigators will compare changes in working memory performance resulting from active tDCS versus sham tDCS during 2-back task compared to 0-back task. The investigators will test the following hypotheses: 1. Acute tDCS will increase working memory performance during active tDCS and larger degree of brain atrophy seen in MCI patients will significantly decrease current intensity in stimulated brain regions. 2. Acute tDCS will significantly increase functional connectivity within the working memory network during active tDCS but not sham. To date, no studies have examined acute tDCS application in MCI cohort and directly comparing results to cognitively healthy cohort. The present study will provide insight into mechanisms underlying tDCS application in MCI population for combating cognitive decline in a rapidly aging population in the United States. Information gathered from this study may guide future intervention strategies to combat cognitive decline and improve the quality of life of aging population.
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Healthy Volunteer
To achieve efficient mobility, our brain dynamically recruits different muscle subsets to create motion strategies that allow us to move and interact with the environment. Our ability to move is a result of interactions involving processes including motivation, adaptation to changes in the environment (e.g., to cope with alterations in the terrain), distractors (e.g., walking while talking over the phone) as well as motor planning and execution. These interactions are expressed through a complex control of gait parameters including speed, rhythmicity and sequencing of muscle co-activations, as well as postural adjustments needed to meet the challenge of external events. Correct information from all the sensory systems involved is synergically needed in active behavior and postural control. A wide range of causes such as neurological damage, traffic accidents and aging are responsible for locomotor deficits that greatly reduce the quality of life by considerably limiting everyday independence. Stroke is the second leading cause of death worldwide, with 6.7 million cases registered in 2012, and an estimated 50% of survivors suffering from permanent motor or cognitive impairments. Hemiparesis, one of the most common sequelae of stroke, is a leading cause of long-term disability, and often results in balance impairments and "foot drop", characterized by the inability to completely lift the toes off the ground during the swing phase of gait in more than 80% of stroke survivors. Stroke reduces the ability to recruit muscles and correctly perceive the body, often resulting in the learned non-use of the affected body part. The reduced capacity for information processing following stroke impairs the ability to efficiently distribute concentration to two or more tasks (dual task), with an increased difficulty with daily living activities that require performing multiple tasks simultaneously (e.g., walking and talking) . As sensorimotor processing capabilities are disrupted, patients are not able to interact freely with the environment as all their mental energy is "usurped" by the simple act of positioning one leg after the other. They do not have the "mental bandwidth" that we normally take for granted and that allows us for example to have a pleasant conversation with other people who are walking with us. In fact, due to the loss of physical and mental bandwidth under dual-task conditions, stroke survivors often experience falls, leading to a lack of confidence, anxiety and in some cases agoraphobia. They are also likely to experience decreased motivation and engagement in the recovery treatment, often spiraling towards a vicious circle detrimental to the success of any rehabilitation therapy attempted. Gait impairment is considered to be one of the most serious disabling sequelae of stroke, as one of the primary goals of patients is being able to walk and manage daily-life activities independently. Stroke induces modifications in locomotion, which is the primary means of daily management of mobility. Gait rehabilitation is thus the primary goal of post-stroke rehabilitation, especially given its close relation to cognitive impairment. Given the constant increase of people requiring rehabilitation or assistance treatment every year and the ever-increasing choice of treatments available, the assessment and development of suitable personalized strategies to address gait impairments is now an impending priority. Unfortunately, rehabilitation outcomes are often uncertain as they are associated with motivation, engagement and attention. Patients' engagement, in fact, will determine the effectiveness of the therapy to engage motor learning (i.e., recognition of the discrepancy between actual and expected outcomes during error-driven learning), which is an essential prerequisite for adaptation (i.e., modification of a movement, trial by trial, based on error feedback). In short, rehabilitation must be performed in a closed-loop fashion, where patients are actively involved in the rehabilitation therapy or even have a measure of control over it while receiving feedback and "rewards" that can promote sensorimotor integration and multisensory processing in the Central Nervous System (CNS). Rehabilitation acts on the mechanisms of brain plasticity, that is the intrinsic capacity of the brain to react as a highly dynamic system that can change the properties of its neural circuits. Reorganization of surviving CNS elements supports behavioral recovery, for example, through changes in interhemispheric lateralization, activity of association cortices linked to injured zones, and organization of cortical representational maps. Human-in-the-loop rehabilitation, by acting on the mechanisms of error-based and reward-based learning, can direct reorganization much more effectively towards increasing the representation of sensorimotor maps, partially (if not completely) lost after a Stroke. Conventional movement rehabilitation is mainly based on therapists' direct observation and mobilization of lower limbs, followed by assisted gait over ground, either passive or active, using context-specific motor tasks and related feedback. In "neurophysiological" techniques, the physiotherapist, based on neurophysiological knowledge of gait principles, acts as "problem solver" and "decision maker", with the patient acting as a passive recipient. In "motor learning" techniques on the other hand active patient involvement is required together with neuropsychological evaluation. To enhance patients' engagement, standardization and therapy effectiveness, enriched motor learning neurophysiological treatments that include robotic assistive devices (exoskeletons) may be used. Over the past 20 years, an overwhelming number of combinations of enriched and conventional treatments has been proposed to increase patients' motivation with interactive biofeedback or by giving patients a measure of control over the assisting robotic devices. Despite an intense debate on the merits of each solution, however, there is still insufficient evidence to clearly indicate which approach is most effective (and most importantly, why) in promoting gait recovery after stroke. In fact, we still lack the knowledge needed to apply such technology in the best possible way in relation to the individual patient's condition, especially in the case of gait rehabilitation. In the last few years Mobile Brain/Body Imaging (MoBI) has gained momentum among the scientific community as an emerging paradigm to jointly study brain and behavior and especially locomotion, also outside laboratory settings. MoBI can be used to provide the clinician with useful information to assess the rehabilitation progress by "encoding" the neural correlates of gait by means of brain-muscle connectivity assessment during movement rather than before/after the task as in current practice. Real-time MoBI may also be used to decode patient's intention of movement based on which to perform stimulus delivery (e.g., through FES, exoskeletons etc.), thus increasing engagement and promoting plastic reorganization. Successful development of MoBI setups is however still a technological challenge. Neuroimaging techniques are either not portable (e.g., Magnetic Resonance, Magnetoencephalography), or lack the temporal resolution necessary to capture near-instantaneous intra-stride modulations of neural activity during locomotion (e.g., functional near-Infrared Spectroscopy - fNIRS) because of the variation speed of the physiological marker they use (e.g., blood oxygen level for fNIRS). Electroencephalography (EEG) is the only technique that is portable enough, non-invasive and with the temporal resolution necessary to detect even such modulations of brain activity during walking. However, the EEG is highly sensitive to movement artifacts and requires solving key technological challenges and developing complex and often discouraging analysis pipelines. In any case, MoBI with EEG, though challenging, is not impossible: to date, several authors showed gait-phase-related intra-stride patterns of activation and deactivation e.g., also demonstrating a directional link between sensorimotor cortical areas and leg muscles during stereotyped gait, but studies of gait rehabilitation with MoBI neuromuscular assessment in natural ecological conditions are still critically missing. Also, the following technical/scientific question remains: "how can we distinguish movement-related neural activity from movement and mechanical artifacts? Atalante X: a disruptive wearable powered cobot. It is a collaborative exoskeleton that enables patients with severe gait impairment, including those with upper extremity dysfunction or cognition challenges to stand up and walk hands-free; it is the only cobot equipped with 12 engines at hip, knee and ankle level that allows human being to transform the intention of movement into actual movement. The project aims to optimize ATALANTE X cutting edge hi-tech solutions personalizing rehabilitation gait treatment of stroke patients using: 1. Characterization of patient's Cognitive Flexibility using Dessintey system. Dessintey is a unique technology dedicated to motor planning and central control of movement based on visuomotor simulation training that combines Action Observation-Motor Imaging-Mirror Therapy approaches. In fact, every time a movement is observed, the brain simulates instantly and without effort this same movement; in this way it is possible to increase imagination and body perception. 2. Monitoring and evaluation of Human-Cobot interaction using disruptive dynamic EEG-EMG neural biomarkers using Mobile Brain/Body Imaging (MoBI)
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Healthy Volunteer
Cognitive assessment plays an important part in decision making in acute neurological settings, partly because difficulties with cognitive skills such as attention, memory and executive functioning (which includes planning and problem-solving) have direct implications for patents' levels of independence and safety upon discharge. A bedside cognitive task that could shed light upon a patient's ability to demonstrate effective goal-directed behaviour (potentially along with other aspects of executive functioning such as cognitive flexibility) would be a useful addition to the existing repertoire of bedside cognitive assessments. One such test could be 'Link's Cube'. The Link's Cube Test is impractical for bedside use in an acute ward setting, as it comprises 27 small blocks. The feasibility study aims to preserve the information that is provided by Link's Cube Test (i.e. an indication of the patient's ability to engage in goal-directed behaviour) whilst altering the testing material such that only nine, slightly larger blocks are used. The objectives for the feasibility study are: * To identify any practical difficulties in administration of the tests that may not be apparent without trialling them * To generate information regarding the timing and sequence of overall administration and in particular the proposed modified Link's Cube test * To obtain feedback from neuropsychologists about ease of administration of the proposed new test and to obtain their views regarding potential benefits
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