[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Motion Informatics LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100624063","safety-and-effectiveness-of-spatial-stimelmd-ssmd-in-subjects-with-upper-limb-neuromotor-impairments-100624063",false,"NCT07404761","Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments","A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation","Inclusion Criteria:\n\n1. Adults aged 18-80 years.\n2. Clinically confirmed diagnosis of stroke or TBI within the past 12 months.\n3. Presence of moderate to severe neuromotor impairment in at least one limb, as evidenced by medical evaluation and a score \\\u003C35 on the Fugl-Meyer Upper Extremity motor subscale (FMA-UE).\n4. Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.\n5. Subject is able to adhere to the study schedule and cognitively capable to perform the treatment.\n6. Stable medical condition without ongoing acute complications that could interfere with participation.\n\nExclusion Criteria:\n\n1. Presence of contraindications to electrical stimulation (ES), including implanted electronic medical devices (e.g., pacemakers, insulin pumps) or conditions that may be exacerbated by electrical stimulation (e.g., uncontrolled epilepsy).\n2. Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.\n3. Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.\n4. Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.\n5. Presence of spinal shock or unresolved acute spinal cord dysfunction, characterized by complete loss of reflexes, flaccid paralysis, or autonomic instability.\n6. Current participation in other clinical trials that could confound the study results.\n7. Severe cognitive impairment that precludes the ability to provide informed consent or reliably adhere to the study protocol, as determined by cognitive screening and clinical judgment.\n8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a multicenter, randomized, controlled clinical study evaluating the safety and effectiveness of the Spatial StimelMD (SSMD) device for upper-limb neuromotor rehabilitation in adults with impairment following stroke or traumatic brain injury (TBI).\n\nParticipants will be randomized to receive either SSMD therapy plus standard rehabilitation care or standard functional electrical stimulation (FES) plus standard care. Subjects will complete approximately 25 supervised treatment sessions over 5-6 weeks, with assessments at baseline, mid-treatment, post-treatment (primary endpoint), and a 1-month follow-up.\n\nThe primary effectiveness endpoint is improvement in upper-limb motor function measured by the Fugl-Meyer Upper Extremity (FMA-UE) assessment. Secondary outcomes include movement metrics, EMG signal strength, functional independence, usability measures, and adverse event monitoring.\n\nThe study plans to enroll approximately 150 subjects to achieve 126 completers, across 2-6 clinical sites.",[26,27,28,29,30],"Stroke","Upper-limb Motor Impairment","Hemiparesis","Spinal Cord Injury","Traumatic Brain Injury",[32,33,34],"randomized","ssmd","neuromotor rehabilitation","RECRUITING","2026-02-08",{"date":38,"type":39},"2026-02-11","ACTUAL",{"date":41,"type":39},"2025-12-22",{"date":43,"type":20},"2026-12-30",{"name":45,"class":46},"Motion Informatics LTD","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100623460","assessment-of-safety-and-effectiveness-of-spatial-stimelmd-ssmd-in-subjects-with-upper-limb-neuromotor-impairments-100623460","NCT07396922","Assessment of Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments","A Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation","Inclusion Criteria:\n\n1. Adult men and women aged 18-80 years.\n2. Clinically confirmed diagnosis of stroke, TBI, spinal cord injury, or peripheral nerve injury within the past 24 months.\n3. Presence of moderate to severe neuromotor impairment in at least one limb, as evidenced by medical evaluation and a score \\\u003C35 on the Fugl-Meyer Upper Extremity motor subscale (FMA-UE).\n4. Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.\n5. Subject is able to adhere to the study schedule and cognitively capable to perform the treatment.\n6. Stable medical condition without ongoing acute complications that could interfere with participation.\n\nExclusion Criteria:\n\n1. Presence of contraindications to electrical stimulation (ES), including implanted electronic medical devices (e.g., Cardiac demand pacemakers, Implantable pacemakers, Implantable cardioverter defibrillators, Implantable neurostimulators, Body-worn devices such as insulin pumps) or conditions that may be exacerbated by electrical stimulation (e.g., uncontrolled epilepsy).\n2. Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.\n3. Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.\n4. Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.\n5. Presence of spinal shock or unresolved acute spinal cord dysfunction, characterized by complete loss of reflexes, flaccid paralysis, or autonomic instability.\n6. Current participation in other clinical trials that could confound the study results.\n7. Severe cognitive impairment that precludes the ability to provide informed consent or reliably adhere to the study protocol, as determined by cognitive screening and clinical judgment.\n8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.","80 Years",{"count":57,"type":20},120,[23],"This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.",[26,61,29,62],"TBI","Peripheral Nerve Damage","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":43,"type":20},{"date":67,"type":20},"2027-01-30",{"name":45,"class":46},""]