[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"motor-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:motor-impairment":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,92,125,164,196,227,271],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100639040","personalized-robotic-telerehabilitation-for-upper-limb-functional-recovery-after-stroke-in-a-home-based-setting-100639040",false,"NCT07590349","Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting","ROBOHOME","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosis of stroke with residual upper-limb motor impairment\n* Upper-limb functional impairment defined by a Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 20 and 50\n* Ability to understand study procedures and provide written informed consent\n* Availability of a home environment suitable for telerehabilitation\n\nExclusion Criteria:\n\n* Presence of severe neurological or musculoskeletal disorders affecting the upper limb\n* Severe spasticity (Modified Ashworth Scale ≥3)\n* Severe upper-limb pain (Numerical Rating Scale \\>4)\n* Skin lesions, infections, or conditions preventing safe use of wearable devices\n* Participation in another interventional clinical trial\n* Any medical or cognitive condition that may interfere with compliance or safe participation in the study","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"NA","Stroke is a leading cause of long-term disability worldwide, with upper-limb impairment representing a major determinant of functional limitation and reduced independence. Conventional rehabilitation approaches are often limited by accessibility, intensity, and long-term adherence, highlighting the need for innovative, home-based solutions.\n\nThis study aims to evaluate the effectiveness of a personalized robotic telerehabilitation program for upper-limb recovery in individuals with post-stroke motor impairment. The intervention combines a wearable robotic device with a virtual reality-based platform, enabling patients to perform structured, task-oriented exercises in a home environment under remote supervision.\n\nParticipants will be allocated to either a robotic-assisted telerehabilitation program or a control condition based on virtual reality-based rehabilitation alone. Motor recovery will be assessed using standardized clinical scales, including the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), along with measures of functional performance, patient-reported outcomes, and treatment adherence.\n\nBy integrating robotic assistance with telemedicine, this study seeks to enhance rehabilitation intensity, improve patient engagement, and facilitate continuity of care beyond traditional clinical settings. The results are expected to support the development of accessible, personalized rehabilitation pathways for individuals with stroke-related upper-limb disability.",[26,27,28,29,30],"Stroke","Hemiparesis","Upper Extremity Paresis","Motor Impairment","Rehabilitation",[32,33,34,35],"stroke","Robotics","Telerehabilitation","Hemiplegia","NOT_YET_RECRUITING","2026-05-14",{"date":39,"type":40},"2026-05-15","ACTUAL",{"date":42,"type":20},"2026-06-01",{"date":44,"type":20},"2027-05-30",{"name":46,"class":47},"University of Campania Luigi Vanvitelli","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":74,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100581994","assessing-intellectual-and-motor-outcomes-in-high-risk-infants-100581994","NCT06857539","Assessing Intellectual and Motor Outcomes in High-risk Infants","The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy","AIM-High","Inclusion Criteria (High Risk Group) :\n\n* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n* All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:\n\n  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight\n  * All encephalopathic infants\n  * Neurological risk factors (e.g., cerebral birth defect, injury\u002Fmalformation on neuroimaging, persistently abnormal neurological exam)\n\n(Control Group)\n\n-A control arm will also be recruited.\n\nExclusion Criteria:\n\n* Death prior to discharge from the neonatal unit (High-Risk Infants only)\n* No parental consent (High-Risk and Control Infants)",true,"0 Days","4 Months",{"count":60,"type":20},600,"30 Months","OBSERVATIONAL","Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.\n\nIn this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre\u002F University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.",[65,66,67,68,69,29,70,71,72,73],"Cerebral Palsy","Cerebral Palsy (CP)","Cerebral Palsy Children","High-risk Infants","Intellectual and Developmental Disabilities","Cognitive Development","HIE - Hypoxic - Ischemic Encephalopathy","Preterm","Prematurity; Extreme",[65,75,76,77,78,79,80],"High-Risk Infant Follow-up","Motor Difficulty","Intellectual Delay","Cognitive Impairment","Hypoxic--Ischaemic Encephalopathy","Prematurity","RECRUITING","2026-05-08",{"date":84,"type":40},"2026-05-13",{"date":86,"type":40},"2025-03-21",{"date":88,"type":20},"2030-07-31",{"name":90,"class":47},"University College Cork",4,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100626725","multifocal-theta-burst-stimulation-to-enhance-upper-limb-motor-recovery-after-stroke-inspire-100626725","NCT07439367","Multifocal Theta-Burst Stimulation to Enhance Upper Limb Motor Recovery After Stroke (INSPIRE)","Advancing Stroke Rehabilitation Through Multifocal Network-based Theta-burst Stimulation and Assistive Technology: Enhancing Upper Limb Motor Learning: A Single-center, Randomized, Sham-controlled Study With Parallel Groups.","INSPIRE","Inclusion Criteria:\n\nFor Stroke Participants:\n\n* Age ≥ 18 years\n* First-ever ischemic or hemorrhagic stroke\n* Time since stroke ≥ 6 months\n* Unilateral upper limb hemiparesis\n* Fugl-Meyer Assessment Upper Extremity (FMA-UE) score between 29 and 57\n* Modified Ashworth Scale score \\\u003C 2 at elbow, wrist, or finger flexors\n* Manual muscle testing ≥ 3\u002F5 in proximal upper limb muscles (deltoid, biceps, triceps, wrist pronators\u002Fsupinators)\n* Ability to understand and follow study procedures\n* Provided written informed consent\n\nFor Healthy Participants:\n\n* Age ≥ 18 years\n* No history of neurological disease\n* Ability to understand and follow study procedures\n* Provided written informed consent\n\nExclusion Criteria:\n\nFor Stroke Participants:\n\n* Second stroke occurring during the study period\n* Botulinum toxin injection within 3 months prior to study start\n* History of one or more epileptic seizures\n* Metallic object near the stimulation site\n* Implanted electronic or metallic devices (e.g., pacemaker, neurostimulator) incompatible with TMS\n* Severe comorbid conditions affecting the upper limb (traumatic, rheumatologic, osteoarticular, or neurodegenerative disorders)\n* Pregnancy\n* Delirium or impaired vigilance\n* Inability to participate in one-hour treatment sessions\n* Inability to comply with study procedures (e.g., language barrier, psychological disorder, dementia)\n* Current or past substance abuse, including excessive alcohol consumption\n* Participation in another interventional clinical trial within 30 days prior to enrollment\n\nFor Healthy Participants:\n\n* Severe musculoskeletal or neurological condition affecting the non-dominant upper limb\n* Pregnancy\n* Delirium or impaired vigilance\n* Inability to participate in one-hour treatment sessions\n* Inability to comply with study procedures\n* Current or past substance abuse, including excessive alcohol consumption\n* Participation in another interventional clinical trial within 30 days prior to enrollment",{"count":101,"type":20},46,[23],"Stroke is one of the leading causes of long-term disability worldwide. Many individuals who survive a stroke continue to experience weakness and reduced control of one arm, even months or years after the event. These motor impairments significantly affect independence, daily activities, and quality of life. Despite rehabilitation efforts, recovery of upper limb function remains incomplete for many patients.\n\nMotor recovery after stroke depends on the brain's ability to reorganize itself, a process known as neuroplasticity. Recent research suggests that motor learning and brain recovery are influenced not only by activity in the primary motor cortex (M1), but also by its functional connectivity with other brain regions, particularly the parietal cortex (PC). Strengthening communication between these regions may enhance motor recovery.\n\nThis study aims to investigate a novel, non-invasive brain stimulation approach called intermittent theta-burst stimulation (iTBS). Unlike traditional stimulation methods that target a single brain region, this study uses a multifocal stimulation protocol targeting both the primary motor cortex and the parietal cortex. The stimulation is combined with structured motor training using an interactive tablet-based rehabilitation device (REAtouch®Lite 2), designed to improve arm movement through goal-directed reaching tasks.\n\nThe study is a single-center, randomized, sham-controlled, triple-blind clinical trial with parallel groups. Thirty-six individuals with chronic stroke-related upper limb impairment will be randomly assigned to receive either active multifocal iTBS or sham (placebo) stimulation. Both groups will complete identical motor training sessions. In addition, ten healthy participants will complete the same motor training protocol (without brain stimulation) to provide reference data.\n\nParticipants will attend six visits over approximately 10 days. Assessments will include motor performance tests using the interactive tablet, a standardized clinical motor scale (Fugl-Meyer Assessment for Upper Extremity), and resting-state electroencephalography (EEG) to measure brain connectivity changes.\n\nThe primary outcome is improvement in motor performance between baseline and one week after the intervention. Secondary outcomes include short-term motor improvements, retention of learning, changes in movement quality, and changes in brain functional connectivity.\n\nThis study seeks to determine whether combining multifocal brain stimulation with targeted motor training can enhance motor learning and promote better recovery of arm function after stroke. If effective, this approach could contribute to the development of more precise, network-based neurorehabilitation strategies.",[105,29,106,107],"Chronic Stroke Patient","Neurorehabilitation","Theta Burst Stimulation",[109,110,111,112,113,114],"Chronic Stroke","Upper Limb Rehabilitation","Intermittent Theta Burst Stimulation","Tablet-Based Rehabilitation","Neuroplasticity","Motor Learning","2026-02-23",{"date":117,"type":40},"2026-02-27",{"date":119,"type":40},"2025-09-05",{"date":121,"type":20},"2026-08-31",{"name":123,"class":47},"School of Health Sciences Geneva",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":135,"conditions":136,"keywords":143,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100625942","impact-study-on-users-of-upper-limb-assistive-devices-100625942","NCT07429188","Impact Study on Users of Upper Limb Assistive Devices","Impact Study on Users of Upper Limb Assistive Devices (AMUSE)","AMUSE","Inclusion Criteria:\n\nFOR PATIENT-USER :\n\n* Age ≥ 18 years\n* Effective use of a CE-marked upper-limb assistance device for at least 60 days\n* Access to a computer with an internet connection and ability to participate in a videoconference\n* Having provided free and informed non-opposition, or, where applicable, their legal representative\n* Cognitive abilities compatible with completing the questionnaires and interviews\n* Medically stable (no ongoing medical event likely to affect the proper conduct of the study)\n\nFOR CAREGIVER-USERS (RELATIVES AND\u002FOR PROFESSIONALS) :\n\n* Age ≥ 18 years\n* Relatives or professionals living with or regularly interacting with the patient-user of an upper-limb assistance device\n* Access to a computer with an internet connection and ability to participate in a videoconference\n* Having provided free and informed non-opposition\n\nExclusion Criteria:\n\nFOR PATIENT-USER :\n\n* Participant enrolled in another protocol evaluating a technical aid\n* Insufficient mastery of the French language\n\nFOR CAREGIVER-USERS (RELATIVES AND\u002FOR PROFESSIONALS)\n\n* Insufficient mastery of the French language\n* Cognitive impairments preventing understanding of the questions",{"count":134,"type":20},150,"This impact study of upper limb (UL) assistance devices is part of the Exploratory PEPR O2R \"Robotic assistance for human movements.\" The integrated project PI3 \"ASSISTMOV,\" composed of a multidisciplinary team in engineering and Human and Social Sciences (HSS), targets the use case of employing robotic assistance for the movement of persons with disabilities (PWD). Through the development of a range of exoskeletons (lower and upper limbs), this project aims for a breakthrough technology enabling fluid and robust interaction with a variety of environments and uses (from rehabilitation to daily life).\n\nThe proposed study contributes to this objective by exploring the clinical and psychosocial dimensions of the daily use of UL assistance devices. Through interviews and questionnaires, it aims to collect data on their impact in terms of independence in activities of daily living (ADL), satisfaction, quality of life, social participation, as well as social perceptions related to the use of these technical aids. It will make it possible to document the benefits and limitations of existing devices from the users' point of view (patients and informal and\u002For professional caregivers), by identifying the factors that facilitate or hinder their adoption and by exploring the care pathway, from prescription to daily use. The questionnaires will also allow examination of economic dimensions.\n\nThe participants included in this study will be recruited among users already using, in their daily life, an UL movement assistance device. All will be regular users of their device, functionally integrated into their usual environment for at least two months. Only devices benefiting from CE marking, guaranteeing their compliance with European regulations, will be eligible. No equipment will be specifically provided within the framework of this research: each participant will share their experience with their own device, as it is integrated into their ADL. A preliminary literature review helped identify the main categories of UL movement assistance devices, grouped according to the following typologies: grasping gloves, mealtime aids, robotic manipulation arms, and arm supports (electric or mechanical).\n\nThe purpose of the approach is both diagnostic and forward-looking. It is diagnostic in that it makes it possible to analyze current practices, real activity, and users' viewpoints, in order to identify elements likely to be improved in the recommendation and use of the devices. It is also forward-looking, since it aims to identify new opportunities, needs, or potential developments, in order to support the thinking of roboticists based on field observations.",[137,138,139,140,141,142,29],"User of an Upper Limb Assistance Device","User Experience","Post-stroke","Spinal Cord Injury","Neuromuscular Disorders","Arthrogryposis",[144,145,146,147,148,149,150,151,152,153],"Family caregiver","upper limb assistance device","user","professional caregiver","CE-marked assistive device","mechanical arm supports","electric arm supports","robotic arms","grasping gloves","mealtime aids","2026-02-17",{"date":156,"type":40},"2026-02-24",{"date":158,"type":40},"2026-02-12",{"date":160,"type":20},"2027-05",{"name":162,"class":47},"Association APPROCHE",2,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":124},"100613552","validation-of-the-viradia-app-for-neurological-and-cognitive-diagnostics-in-virtual-reality-100613552","NCT07268079","Validation of the VIRADIA App for Neurological and Cognitive Diagnostics in Virtual Reality","Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the Assessment of Neurological and Cognitive Functions","VIRADIA","Inclusion Criteria:\n\n* Age 18-80 years.\n* Ability to provide informed consent.\n* Adequate vision and hearing to complete testing.\n* For the neurological group: confirmed diagnosis of a neurological disorder (e.g., Parkinson's disease, multiple sclerosis, or similar).\n* For the control group: no history of neurological or psychiatric disease.\n\nExclusion Criteria:\n\n* Severe cognitive impairment (MMSE \\\u003C 24 or equivalent clinical judgment).\n* Acute neurological or psychiatric condition interfering with testing.\n* Severe motor disability preventing task performance (e.g., inability to use VR controller).\n* Current substance abuse.\n* Uncorrected visual impairment or vestibular disorder leading to intolerance of VR.","80 Years",{"count":174,"type":20},200,"The VIRADIA study aims to validate and assess the reliability of a newly developed Virtual Reality (VR) diagnostic platform designed for neurological and cognitive testing. The goal is to determine whether the VR versions of nine commonly used clinical tests measure the same constructs and provide comparable results to their traditional face-to-face or paper-based forms.\n\nThe study includes two groups of participants: (1) healthy volunteers and (2) patients with neurological diagnoses. Each participant will complete both the standard and the VR versions of the tests, with the order of administration randomly assigned. The tested functions cover fine motor skills, gait and balance, attention, executive function, processing speed, and visuospatial abilities.\n\nThe following tests are included in the VR platform: 9-Hole Peg Test (9HPT), 6 Meter Walk Test, Timed Up and Go - Manual (TUG-M), Functional Reach Test (FRT), Symbol Digit Modalities Test (SDMT), Clock Drawing Test (CDT), Trail Making Test (TMT A\u002FB), Stroop Test, and SATURN Test.\n\nParticipants will first provide informed consent and basic demographic information. They will then complete all tests in both modalities (standard and VR), with appropriate breaks between tasks.\n\nThe study is observational, within-subjects, and paired in design. Primary outcomes include correlation and agreement between VR and standard test scores (validity). Data will be analyzed using paired statistical methods, including Pearson\u002FSpearman correlations, Bland-Altman analysis, and Intraclass Correlation Coefficients (ICC).\n\nNo medication or invasive intervention is used in this study. The VR testing is non-invasive and carries minimal risk. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804).\n\nThe results will provide evidence for the validity and reliability of VR-based diagnostics and support the use of the VIRADIA platform as a safe, standardized tool for neurological and cognitive assessment.",[177,78,29,178],"Neurological Disorders","Neurodegenerative Diseases",[180,181,182,183,184,185,186],"Virtual Reality","Neurological Diagnostics","Cognitive Assessment","Motor Function","Neuropsychology","Validity","Digital Health","2025-12-03",{"date":189,"type":40},"2025-12-05",{"date":191,"type":20},"2025-12-01",{"date":193,"type":20},"2026-05-01",{"name":195,"class":47},"Gametherapy",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":213,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":124},"100593753","effect-of-virtual-reality-based-music-therapy-on-cognitive-and-motor-skills-in-subacute-stroke-patients-100593753","NCT07010536","Effect of Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients","Effect of Immersive Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients","Inclusion Criteria:\n\n* Voluntary participation\n* Age between 50 and 75 years\n* Stroke onset more than 2 weeks and less than 6 months prior\n* Diagnosis of unilateral hemiplegic stroke\n* Preserved understanding, hearing, and speech abilities sufficient to engage with virtual reality games\n\nExclusion Criteria:\n\n* Medically unstable condition\n* Wheelchair use or inability to sit in a chair\n* Cognitive impairment preventing comprehension of study procedures\n* Hearing loss\n* Severe visual impairment\n* Refusal to participate in the study\n* Epilepsy\n* Migraine with aura\n* History of motion sickness","50 Years","75 Years",{"count":206,"type":20},30,[23],"This clinical trial aims to investigate the effects of immersive virtual reality-based music therapy on cognitive and motor functions in individuals aged 50 to 75 years with subacute stroke (between 2 weeks and 6 months post-stroke). Participants will be randomly assigned to either a control group receiving conventional physiotherapy or an experimental group receiving conventional physiotherapy plus virtual reality-based music therapy.\n\nThe study will assess cognitive performance, upper extremity motor skills, stroke impact, balance, and spatial neglect before and after a 6-week intervention. All participants will be treated at Istanbul Aydın University VM Medical Park Hospital. The study has been approved by the ethics committee, and written informed consent will be obtained from all participants.",[26,210,180,211,212,29],"Subacute Stroke","Immersive Virtual Reality","Cognitive Dysfunction",[26,214,180,215,216,217],"Music Therapy","Cognition Disorders","Motor Skills Disorders","Postural Balance","2025-05-30",{"date":220,"type":40},"2025-06-08",{"date":222,"type":40},"2025-03-22",{"date":224,"type":20},"2025-12-20",{"name":226,"class":47},"Suzan Aydın",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":250,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":124},"100588304","bci-assisted-scs-exs-for-gait-optimization-100588304","NCT06939660","BCI-Assisted SCS-EXS for Gait Optimization","Spatiotemporal Spinal Cord Stimulation Based on Implantable Brain-machine Interfaces and Exoskeletons for Spinal Cord Injury (BASEGO)","BASEGO","Inclusion Criteria:\n\n* Age 14-65 years, any gender.\n* Clinical diagnosis of spinal cord injury (SCI) due to trauma, inflammation, tumor, vascular disease, or iatrogenic factors, confirmed by medical history, physical examination, and ancillary tests, resulting in lower limb motor dysfunction.\n* SCI diagnosed ≥6 months prior, with ≥1 month of continuous conventional rehabilitation (e.g., physical therapy, acupuncture, hydrotherapy, ≥3 hours daily) without significant improvement in motor function in the past 2 months.\n* ASIA Impairment Scale (AIS) grade A, B, or C based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).\n* Good general health with a life expectancy ≥12 months.\n* Mini-Mental State Examination (MMSE) score ≥22.\n* Educational attainment of secondary school or above.\n* Willingness to participate, provide informed consent, and comply with study follow-up.\n\nExclusion Criteria:\n\n* Presence of diseases other than spinal cord injury (SCI) that affect lower limb motor function, including brain diseases (e.g., brain tumor, stroke), lower limb vascular diseases (e.g., lower limb vascular occlusion), peripheral nerve diseases, or lower limb bone diseases (e.g., osteoarthritis, joint contracture).\n* Requires continuous medical interventions (e.g., tracheal intubation, nasogastric feeding) to maintain critical physiological functions (e.g., heartbeat, respiration, swallowing).\n* Congenital or acquired structural abnormalities of the lower limb bones or muscles.\n* Presence of surgical contraindications (e.g., anesthesia-related adverse reactions, coagulation risks, or surgeon's determination of unsuitability for surgery).\n* Presence of active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants, sacral nerve stimulators).\n* Unable to receive implantable devices due to other disease treatments or investigations, or requires magnetic resonance imaging (MRI) during the device implantation period.\n* MRI shows structural damage \\>50% in motor function areas (precentral and postcentral gyri, ventromedial sensorimotor areas, mid temporal lobe, Broca's area, Wernicke's area, Geschwind's area), or DTI shows damage \\>50% in the posterior limb of the internal capsule.\n* Severe cardiovascular disease: Above level II myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms in men, ≥470 ms in women), level III-IV heart failure (NYHA classification), or echocardiography showing LVEF \\\u003C50%.\n* Coagulation abnormalities (INR \\>1.5 ULN, PT \\>ULN +4 s, or APTT \\>1.5 ULN), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy.\n* Severe infections within 4 weeks before surgery (requiring IV antibiotics, antifungals, or antivirals) or lumbar soft tissue infections, or unexplained fever \\>38.5℃ during screening or before surgery.\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥500 IU\u002Fml), hepatitis C (positive HCV antibody and detectable HCV-RNA), or co-infection of hepatitis B and C.\n\nSevere cerebrovascular events (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism within 12 months before enrollment.\n\n* Metastatic malignancies or untreated malignant tumors.\n* Major surgery or severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment.\n* Addictive habits such as drug abuse or alcoholism.\n* History of psychotropic drug abuse that is not controllable or presence of mental disorders, including major psychiatric illnesses (e.g., depression \\[BDI score \\>20\\], anxiety, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorders, consciousness disorders).\n* Pregnant, breastfeeding, planning to conceive, or women of childbearing potential without reliable contraception.\n* Participation in other clinical trials within the past month.\n* Cognitive impairments or poor compliance from subjects, family members, or caregivers, or inability to complete at least 12 months of follow-up and rehabilitation training.\n* Other conditions that increase the risk of study participation or device use, as determined by the investigator.","14 Years","65 Years",{"count":238,"type":20},3,[23],"The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI.\n\nParticipant Population:\n\nAdults aged 14-65 years (sex\u002Fgender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C.\n\nIndividuals with stable health status, MMSE ≥22, and secondary education or above.\n\nPrimary Questions:\n\n1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation?\n2. Does the system improve lower limb motor function and quality of life in SCI patients?\n\nInterventions:\n\nParticipants will undergo the following procedures:\n\nPhase I (Implantation):\n\nBCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent.\n\nSCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation.\n\nPhase II (System Calibration):\n\nBCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters.\n\nSCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training.\n\nPhase III (Rehabilitation):\n\nDaily BCI-SCS-EXS training sessions (60 minutes, 5 times\u002Fweek for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance.\n\nRemote monitoring of device performance and emergency intervention for technical issues.\n\nOutcome Measures:\n\nPrimary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life).\n\nEthics and Safety:\n\nInformed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines.\n\nParticipant confidentiality will be strictly maintained. This study will provide foundational evidence for the safety and feasibility of the BCI-SCS-EXO system, paving the way for future randomized controlled trials in SCI rehabilitation.",[242,243,140,244,245,246,29,247,248,249],"Spinal Cord Injuries (SCI)","Spinal Cord Injury, Chronic","Spinal Cord Injury Cervical","Spinal Cord Injury Thoracic","Spinal Cord Injury (Quadraplegia)","Motor Deficits","Gait Training","Gait Impairment",[251,252,253,30,254,255,256,257,258,259,260,261],"Brain-computer interface","Spianl cord stimulation","Exoskeleton","Spinal cord injury","Motor dysfunction","BCI","Brain-spinal interface","BSI","Brain-machine interface","Gait training","Neural plasticity","2025-05-14",{"date":264,"type":40},"2025-05-20",{"date":266,"type":40},"2025-04-23",{"date":268,"type":20},"2027-04-30",{"name":270,"class":47},"Xuanwu Hospital, Beijing",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":204,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":286,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":124},"100584872","transcutaneous-auricular-vagus-nerve-stimulation-in-patients-with-stroke-100584872","NCT06895005","Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke","Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke","INPULSE","Inclusion Criteria:\n\n* Age \\>18 years and \\\u003C75 years\n* Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.\n* Modified Rankin Scale between 0 and 1 before stroke\n* Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.\n* Ability to provide written informed consent.\n* Hemodynamically stable patients.\n* Patients residing in the metropolitan area of Bucaramanga.\n\nExclusion Criteria:\n\n* Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score \\> 2, item 9 score \\> 1, item 11 score = 2.\n* Medical conditions that could interfere with study participation, for example ear infections or skin wounds.\n* Bradycardia (\\\u003C 50 bpm) or hypotension (\\\u003C 90\u002F60 mmHg)\n* Significant pre-existing disability\n* History of stroke\n* History of cardiac arrhythmia\n* History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.\n* Pregnant or planning on becoming pregnant or breastfeeding during the study period.\n* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.\n* Subjects who are currently in another clinical trial or plan to do so during the study period.\n* Patient receiving any therapy at study entry that would interfere with VNS (e.g., drugs that interfere with neurotransmitter mechanisms: anticholinergics, adrenergic blockers, etc.).\n* Prior injury to vagus nerve.\n* Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug.",{"count":206,"type":20},[23],"This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.",[29,283,26,284,285],"Motor Impairments","Stroke; Sequelae","Stroke, Ischemic",[26,287,288,289,30],"Vagus nerve","Vagus nerve stimulation","Transcutaneous vagus nerve stimulation","2025-03-25",{"date":292,"type":40},"2025-03-30",{"date":294,"type":20},"2025-04-01",{"date":296,"type":20},"2025-12-24",{"name":298,"class":47},"Fundación Cardiovascular de Colombia"]