[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"apraxia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:apraxia":29},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100658181","deep-brain-stimulation--therapy-for-stroke-100658181",false,"NCT07849114","Deep Brain Stimulation + Therapy for Stroke","Deep Brain Stimulation of the Motor Thalamus Combined With Speech and Swallowing Therapy to Improve Post-Stroke Motor Speech and Swallowing Production Impairments","Inclusion Criteria:\n\n1. Participants must have suffered an ischemic or hemorrhagic stroke causing motor speech and swallowing deficits as a result. For ischemic stroke, the event needs to have occurred more than 6 months before the time of enrollment, whereas, for hemorrhagic stroke, the event needs to have occurred more than 12 months before the time of enrollment. Prior strokes that did not cause motor speech or swallowing deficits are not exclusionary.\n2. Participants must be between the ages of 22 and 75 years old.\n3. English speaker.\n4. Participants must have 30-84% intelligibility on the Speech Intelligibility Test (SIT), score ≤14 on the Communicative Participation Item Bank (CPIB) AND an instrumental swallowing assessment (VFSS or FEES) demonstrating Penetration-Aspiration-Scale (PAS) ≥ 2.\n\nExclusion Criteria:\n\n1. Participants must not have any serious disease or disorder (e.g., neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study.\n2. Participants must not have a high risk of recurrent stroke as evident from their medical history or upon judgment of the study physician.\n3. Participants must not have a score on the Short Blessed Test assessment scale of ≥10.\n4. Female participants of child-bearing age must not be pregnant or breastfeeding during the study.\n5. Participants that cannot suspend their antiplatelets and\u002For anticoagulant therapy including aspirin, clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa) for two weeks around the surgery will be excluded from participation.\n6. Participants may not have any implanted medical device that is not MRI safe and must not have any active medical devices, including implanted stimulation devices, even if they are MRI safe.\n7. Participants cannot have severe claustrophobia that can prevent them from executing the required MRI imaging sessions.\n8. Participants must not be taking oral or systemic anti-spasticity or anti-epileptic medications or facial and\u002For neck anti-spasticity injections (e.g., cosmetic Botox, migraine treatment, or bruxism\u002FTMJ treatment) for 3 months prior to enrollment in the study and for the duration of the study. Participants may continue anti-spasticity injections localized to the upper- and\u002For lower-limbs.\n9. Participants with a T-score \\>63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator, and a study physician will be excluded from participation.\n10. Participants with gross anatomical variances in MR imaging or cerebral vascular accidents involving motor thalamus and cerebellar areas.\n11. Participants must not have any lesions in the lower motoneuron causing flaccid dysarthria and\u002For bulbar dysphagia.\n12. Participants with deficits affecting language (i.e., pure aphasia) and not speech deficits.\n13. Participants with diabetes mellitus whose recent Hemoglobin A1C value is 8.0% or greater.","ALL","22 Years","75 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the safety and potential benefits of combining deep brain stimulation (DBS) with targeted speech and swallowing rehabilitation in individuals who have experienced a stroke and have moderate to severe difficulties with speech and\u002For swallowing. Speech difficulties may include apraxia, which affects the ability to plan and coordinate speech movements, and dysarthria, which affects the ability to produce clear speech. Participants may also have difficulty swallowing (dysphagia).\n\nThe primary objective of this feasibility study is to evaluate the safety of the SR-DBS system in individuals with post-stroke speech and swallowing difficulties. The secondary objective is to evaluate whether combining DBS with speech and swallowing rehabilitation improves motor speech and swallowing function and reduces related impairments. The study will compare outcomes following rehabilitation alone with outcomes following rehabilitation combined with DBS to determine whether the addition of DBS provides greater improvements in speech and swallowing function.",[27,28,29,30,31],"Stroke","Dysarthria","Apraxia","Dysphagia","Hemiparesis After Stroke",[33],"deep brain stimulation","NOT_YET_RECRUITING","2026-09-23",{"date":37,"type":38},"2026-09-30","ACTUAL",{"date":40,"type":21},"2027-01",{"date":42,"type":21},"2030-07",{"name":44,"class":45},"Pirondini, Elvira, PhD","OTHER"]