Clinical Research Directory

Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks

This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-drinking test, videofluoroscopic swallowing study (VFSS), and ultrasonography to identify the optimal frequency. In parallel, diffusion tensor imaging (DTI) will be used to evaluate changes in fiber connectivity between swallowing-related cortical regions (bilateral precentral gyrus, insula, supramarginal gyrus, and frontal lobe) and the medullary nucleus tractus solitarius, thereby exploring neural network remodeling and providing mechanistic evidence to inform clinical practice.

Decoding Motor Imagery From Non-invasive Brain Recordings as a Prerequisite for Innovative Motor Rehabilitation Therapies

Seminal studies in motor neuroscience involving healthy subjects have revealed time-locked changes in induced power within specific frequency bands. Brain recordings were shown to exhibit a gradual reduction in signal power, relative to baseline, in the mu and beta frequency bands during an action or during motor imagery: the event-related desynchronization (ERD). This is considered to reflect processes related to movement preparation and execution and is particularly pronounced in the contralateral sensorimotor cortex. Shortly following the completion of the task, a relative increase in power, the event-related synchronization (ERS), could be observed in the beta band. ERS is thought to reflect the re-establishment of inhibition in the same area. Ever since the characterization of the ERD and ERS phenomena, there has been little to no discussion in the field of non-invasive Brain Computer Interfaces (BCI) as to whether these features accurately capture the task-related modulations of brain activity. Recent studies in neurophysiology have demonstrated that the ERD and ERS patterns only emerge as a result of averaging signal power over multiple trials. On a single trial level, beta band activity occurs in short, transient events, bursts, rather than as sustained oscillations. This indicates that the ERD and ERS patterns reflect accumulated, time-varying changes in the burst probability during each trial. Thus, beta bursts may carry more behaviourally relevant information than averaged beta band power. Studies in humans involving arm movements have established a link between the timing of sensorimotor beta bursts and response times before movement, as well as behavioural errors post-movement. Beta burst activity in frontal areas has also been shown to correlate with movement cancellation and recent studies show that activity at the motor unit level also occurs in a transient manner, which is time-locked to sensorimotor beta bursts. Although beta burst rate has been shown to carry significant information, it still comprises a rather simplistic representation of the underlying activity. Indeed, complex burst waveforms are embedded in the raw signals, and can be characterized by a stereotypical average shape with large variability around it. The waveform features are neglected in standard BCI approaches, because conventional signal processing methods generally presuppose sustained, oscillatory and stationary signals, and are thus inherently unsuitable for analysing transient activity. In contrast to beta, activity in the mu frequency band is oscillatory even in single trials. This activity is typically analysed using time-frequency decomposition techniques, which assume that the underlying signal is sinusoidal. However, there is now growing consensus that oscillatory neural activity is often non-sinusoidal and that the raw waveform shape can be informative of movement. In this project, the design of a subject-specific neurophysiological model to guide motor BCI training will be optimized using Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) for high spatial and biophysical specificity in the experimental group. Anatomical MR volumes will be used to design and 3D-print an individual head cast that will be used in the MEG scanner to stabilize the head position and minimize movements. This high-precision approach (hpMEG) has been proven to significantly improve source localization up to the level of distinguishing laminar activity, which makes it superior to EEG recording technique. An individualized hpMEG approach, as well as the widely adopted EEG, will be used to study bursts of oscillatory activity in the beta and mu frequency bands related to motor imagery and motor execution. hpMEG will yield subject-specific models of motor imagery that will be used to constrain online decoding of EEG data. This approach will be applied and validated on a group of healthy adult subjects and will then be compared against another feasibility group of patients and age-matched healthy participants. The proposed approach will be compared with a classic EEG-based BCI approach. The information will be used to optimally guide subsequent EEG-based BCI training in the control group. After a thorough investigation in healthy subjects in this project, the feasibility of the approach will be evaluated in a few stroke patients with upper-limb motor deficits. Tasks 1.1 and 1.2 aim to develop subject-specific generative models decoding movement onset and offset, the type of movement, as well as finely discretized movement amplitude during both real and imagined wrist extensions/flexions. Task 1.2 investigates how lesions of patients alter our ability to decode attempted wrist movements.

Home Tele Rehabilitation Therapy for Vascular Dementia

To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)

Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

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 chronic 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).

A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors

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).

Accelerated rTMS vs. Sham for Stroke Apathy

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of them. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, investigators are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. This study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). This study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabilitation in Subchronic Stroke: A Feasibility Study

The goal of this interventional study is to evaluate the effect of multichannel functionnal electrical stimulation for subchronic stroke gait rehabilitation. The main questions it aims to answer are: * Does this new therapy help improve walking speed? * Evaluate other aspects of therapeutic effectiveness such as different aspects of walking endurance, mobility, postural instability and autonomy. * Evaluate physiological aspects of autonomous gait such as spasticity, muscle strength and motor and sensorimotor recovery. * Evaluate the acceptability of this new therapy and its effect on quality of life.

TDCS to Improve Post-Stroke Cognitive Impairment

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.

Neural Bases of Post-stroke Emotion Perception Disorders

This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG.

Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients

The goal of this clinical trial is to learn if trans-spinal magnetic stimulation works to treat gait disorders in chronic stroke adults. It will also learn about the safety of trans-spinal magnetic stimulation. The main questions it aims to answer are: Does trans-spinal magnetic stimulation enhance chronic stroke participants gait and functional mobility? Does the technique cause any side effects? Researchers will compare trans-spinal magnetic stimulation to a sham (a look-alike stimulation with no real effect) to see if trans-spinal magnetic stimulation works to treat gait disorders and improve functional mobility. Participants will: Receive trans-spinal magnetic stimulation with treadmill training or a sham stimulation with treadmill training every day for 2 weeks.

Imaging Post-Stroke Recovery: Using MEG to Evaluate Cognition

This is a study using magnetoencephalography (MEG) to look at recovery in those with minor stroke. The investigators know that these individuals report difficulties in attention, concentration, multi-tasking, energy level, and processing speed that appear to be independent of lesion size or location. The underlying pathophysiology is unclear; however, anecdotally, many individuals are significantly improved by 6 months post-stroke. One hypothesis is that a single lesion, regardless of size, may disrupt the classic neural networks required for cognitive function. The investigators are currently collecting data to better characterize these difficulties and stroke patients' recovery as part of a previously approved recovery study. In this sub-study, the investigators propose to add MEG at 1 and 6 months in a subset of individuals with small: 1) subcortical, and 2) cortical lesions. The investigators will partner with colleagues at the University of Maryland (College Park), who are well experienced with MEG to conduct this research. In addition a control population of age-similar individuals will be recruited for comparison. Cerebral activation patterns of individuals with stroke versus controls will be compared, both across patients with stroke at a given time point, and within subjects from 1 to 6 months to determine the association of abnormal activation with cognitive dysfunction and recovery. \*\*The investigators have recently extended follow-up by adding an additional assessment at 12 months and will enroll additional participants (up to 40 patients with minor stroke, 15 age-similar controls).

Prevalence of Central Neuropathic Pain After a Stroke in Patients Attending Post-stroke Consultations in the Île-de-France Region

Post-stroke pain is common, affecting 15-50% of patients and significantly impacting their quality of life, rehabilitation, and functional recovery. There are different types of post-stroke pain, including peripheral pain related to spasticity, shoulder pain, complex regional pain syndrome, and headaches, as well as central pain linked to brain lesions. Central Post-Stroke Pain (CPSP) is diagnosed when the pain has neuropathic characteristics (burning, cold, tightness, compression), possibly accompanied by allodynia, hyperesthesia, and sensory-motor disorders localized to the area affected by the stroke. CPSP disrupts sleep, impairs functional rehabilitation, and can lead to depression, anxiety, substance abuse, and cognitive disorders. The prevalence of CPSP varies, ranging from 1% to 35%, but it is likely underreported due to difficulties in detection caused by cognitive or communication issues, the clinical variability of CPSP, and its coexistence with other types of post-stroke pain. CPSP often remains resistant to standard neuropathic pain treatments, such as anticonvulsants and antidepressants, which may cause side effects that reduce patients' autonomy and quality of life. Non-pharmacological therapies used in other chronic pain conditions may offer promising alternatives, but have not been widely studied in CPSP. Improved clinical characterization of CPSP patients is essential. Following a 2015 decree by the French Ministry of Health, post-stroke consultations are standardized, providing a good opportunity for systematic pain screening. The study proposes a systematic screening of different types of pain during post-stroke consultations, categorizing patients into three groups: those with CPSP, those with pain from another mechanism, and those without pain.

Data Collection of Patients Admitted to the Stroke Unit

The purpose of this prospective observational study is to create a database in which data will be collected from every patient admitted to the Stroke unit and who has explicitly given his or her informed consent for this data collection. The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.

Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.

Stroke is the third most common cause of disability worldwide and leads to upper limb motor disease in more than half of people affected. Recent data demonstrate that upper limb rehabilitation can be pursued using techniques such as the observation of action (Action Observation Therapy - AOT) or the stimulation of limb musculature using surface electrodes (Neuromuscular Electrical Stimulation - NMES). To date, no rehabilitation studies used both the treatments (AOT-NMES) for the rehabilitation of upper limb after stroke. The goal of this clinical trial is to study the efficacy of this combined approach (AOT-NMES) in people who developed upper limb motor impairment after stroke. The main question this study aims to answer is if the rehabilitation performed using both action observation and neuromuscular stimulation has an higher efficacy than the use of AOT alone and higher than the observation of non-motor stimuli. Participants will be people with upper limb impairment after stroke and will perform 15 rehabilitation sessions (5/week, 3 weeks, 60 minutes each). Each participant will be casually included in one of following three rehabilitation groups: * Action observation associated with neuromuscular stimulation (AOT-NMES, experimental condition): they will observe upper limb movements while their arm muscles will be stimulated. After the observation phase they will try to perform the same movements with the impaired arm. * Action observation alone (AOT): subjects will observe upper limb movements and after the observation phase then they will try to execute them with the impaired arm. * Motor-neutral observation (MNO): subjects will observe non-movement videos and after the observation phase they will try to execute upper limb movements with the impaired arm. Each participant will be evaluated for motor function before and after rehabilitation treatment and researchers will compare the motion improvement between the groups to assess the efficacy of AOT-NMES over other treatments.

Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery

Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.

Virtual Reality Versus Constraint-induced Movement on Hemiparesis in Cerebrovascular Event

The objective of this clinical trial is to measure the effect of Rehabilitation with Virtual Reality or Modified Constraint-Induced Movement Therapy on hemiparesis in patients with Cerebral Vascular Event. The question to be answered is: What is the effect of different therapeutic modalities supported by Virtual Reality or Modified Constraint-Induced Movement Therapy compared with usual Physical and Occupational Therapy on motor recovery of paretic limbs in patients with Cerebrovascular Event? The patients will carry out activities of: * Virtual reality or * Movement Restriction-Induction Therapy. The investigators will compare the changes in the functionality of the paretic hemibody with a group undergoing regular physical and occupational therapy, as well as language and treatment-related satisfaction.

Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients: A Pilot Study

Exercise Rehabilitation (ER) is widely used and effective in the treatment of chronic diseases; however, patients do not adhere to ER programs. Tele-rehabilitation is effective and often used to support and improve patient adherence. Thus, the ADEPINA device could be a promising solution for the individualized management of patients by their therapists. The aim of the study will be: a) To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease. Additionally, the study will assess the individualized program' adherence and his effect on patients' physical fitness and quality of life. Methods: Fifty patients will follow individualized ER sessions to their patients (with chronic diseases) using the ADEPINA device, 2 to 3 times per week for 12 weeks. At the end of the intervention, the investigator will assess patients' lower limb strength (with sit to stand test), dynamic balance (Timed up and go test), patients' adherence to the ER program by evaluating the usage time of the system by participants, the treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire. The investigator will also evaluate the patients' quality of life (using the "World Health Organization Quality of Life" (WHOQOL) scale) at the beginning and end of the intervention. Discussion: This interventional pilot study could have positive impacts for participants and explore gaps in the current literature regarding the individualized telerehabilitation program' feasibility.

Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. Improving walking is therefore a primary rehabilitation goal for such patients. Robotic-Assisted Rehabilitation (RAR, e.g. exoskeletons) and Functional Electrical Stimulation (FES) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.

Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

Background: Hemiplegia is a common complication after a stroke. Studies have shown that traditional medical and rehabilitation treatments are not good for improving patients' motor function, deep brain stimulation (DBS) and vagus nerve stimulation (VNS) can improve the motor function of patients, but there is no comparative study between them. Objectives: This study compares the efficacy and safety of DBS and VNS in the recovery of motor function in patients with post-stroke hemiplegia, determining the best treatment for patients with post-stroke hemiplegia, and providing high-level clinical evidence for patients and clinicians to choose from. Methods/Design: This is a randomized, double-blind, sham-controlled, cross-controlled pilot study. A total of 98 patients with post-stroke hemiplegia are assigned to receive DBS or VNS. After 3 and 6 months of follow-up, all the devices are turned off. After a 2-week washout, the control group is turned on, but the stimulation group is given sham stimulation. After 9 and 12 months of follow-up, all the devices are turned on. Then, at postoperative 15 and 18 months, postoperative neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: We propose a study design and rationale to compare the efficacy and safety of DBS and VNS in patients with post-stroke hemiplegia to provide evidence and reference for implantable neuromodulation in the treatment of post-stroke dysfunction, and to compare the therapeutic effects of DBS and VNS to provide evidence for patient and clinical diagnosis and treatment choices. Study limitations are related to the small sample size and short study period.

Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region（MLR） for Poststroke Hemiplegia

Abstract: Background: The leftover movement disorder of stroke patients is one of the main causes of disability, and there is still no specific solution. Studies have shown that the improvement of movement disorder symptoms in patients receiving DBS is a potential therapy. treatment approach. However, at present, there are few large-sample studies in this area at home and abroad, which cannot well reveal its actual therapeutic effect and safety, and do not fully understand its potential neural mechanisms, so it is impossible to form a unified and standardized treatment standard, which limits its wide application in clinical practice. Objectives: This study aimed to determine the efficacy and safety of hemiplegia recovery after deep brain electrical stimulation in stroke patients with hemiplegia. Methods/Design: This was a double-blind randomized cross-over controlled pilot study in which 62 patients were assigned to receive deep brain stimulation (DBS) and randomized into DBS and control groups using a randomized controlled study approach, DBS group One month after the operation, electrical stimulation was started, and the control group was given sham stimulation treatment. After 3 and 6 months of follow-up, all the machines were turned off. After a 2-week washout period, the control group was turned on, but the DBS group was given sham stimulation. After the 9th and 12th month of follow-up, all patients were given start-up treatment, and neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: The investigators propose a research design and rationale to explore the effectiveness and safety of DBS in patients with post-stroke hemiplegia, and provide evidence and reference for DBS in the treatment of post-stroke dyskinesia. Study limitations are related to the small sample size and short study time period.

MLC1501 Study Assessing Efficacy in STROke Recovery

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.

Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program

Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account. Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty. To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.