[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Encora, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100598971","home-use-study-of-targeted-mechanical-stimulation-for-tremor-relief-100598971",false,"NCT07078422","Home Use Study of Targeted Mechanical Stimulation for Tremor Relief","Inclusion Criteria - Alpha and Beta Phase B1\n\n* Age 18 years or older, able to comply with all study procedures and capable of providing informed consent.\n* Mentally competent to understand and able to perform written, informed consent to participate in the study\n* A diagnosis of either ET or PD as determined by clinical history\n* Moderate to severe upper limb tremor\n\nExclusion Criteria - Alpha and Beta Phase B1\n\n* Pregnant women\n* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site\n* History of psoriasis, eczema or atopic dermatitis at the stimulation site\n* History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy\n* Participant unable to communicate with sponsor\u002Finvestigator and staff\n* Any other medical conditions or physical or mental impairments that in the sponsor\u002Finvestigator's opinion would render the subject unsuitable as a candidate for the study.\n\nInclusion Criteria - Beta Phase B2\n\n* Age 18 years or older, able to comply with all study procedures and capable of providing informed consent\n* Mentally competent to understand and able to perform written, informed consent to participate in the study\n* For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria\n* For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist\n* For ET subjects, at least one hand exhibiting tremor \\> 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit\n* For PD subjects, a score \\> 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of \\> 3 on one of the following subject-assessed items of the Bain \\& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter\n* Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation\n* For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits)\n* A wrist circumference of 6.0 - 8.1 inches\n\nExclusion Criteria - Beta Phase B2\n\n* Pregnant women\n* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site\n* History of psoriasis, eczema or atopic dermatitis at the stimulation site\n* History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and -diabetic neuropathy\n* Participant unable to communicate with sponsor\u002Finvestigator and staff\n* Any other medical conditions or physical or mental impairments that in the sponsor\u002Finvestigator's opinion would render the subject unsuitable as a candidate for the study","ALL","18 Years",{"count":18,"type":19},80,"ESTIMATED","INTERVENTIONAL",[22],"NA","Subjects will receive prototype devices to be used for participation. The study comprises three phases:\n\n1. Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use.\n2. Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions.\n3. Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.",[25,26],"Essential Tremor","Parkinson's Disease","RECRUITING","2025-11-19",{"date":30,"type":31},"2025-11-24","ACTUAL",{"date":33,"type":31},"2025-01-01",{"date":35,"type":19},"2026-06",{"name":37,"class":38},"Encora, Inc.","INDUSTRY",""]