[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nicolas Nicastro\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"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":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100639947","virtual-reality-based-mindfulness-training-for-mental-health-after-stroke-100639947",false,"NCT07614373","Virtual Reality-based Mindfulness Training for Mental Health After Stroke","VITAL","Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke \\>6 months before inclusion\n* Anxiety-HAD score at inclusion \\>= 8\n\nExclusion Criteria:\n\n* Blindness\n* Deafness\n* Photo-sensitive epilepsy\n* unstable psychiatric condition","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"NA","Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients.\n\nAim: to evaluate the effect of a virtual reality (VR)-based medical device (HypnoVR®) on anxiety and stress reduction in patients with chronic stroke. Other outcomes, including depression, neurological fatigue and quality of life will be assessed.\n\nMethodology: a randomized controlled trial including patients who had an ischemic or hemorrhagic stroke (\\>6 months) and experience significant anxiety - Hospital Anxiety and Depression Scale (HADS) ≥ 8 for anxiety. Intervention includes 3 weekly HypnoVR® sessions for 3 weeks (total: 9), with clinical assessments at baseline, post-intervention (end of week 3) and at a 8-week follow-up. The sessions will be supervised by a research assistant and will take place in our outpatient clinic. Participants will be randomly assigned to either an immediate treatment group or a delayed treatment group (waiting list), the latter acting as both controls and active participants.\n\nPotential significance: VR-based therapeutic interventions are emerging as promising solutions to improve mental health but require solid scientific studies to assess their efficacy. This study provides a safe, non-invasive intervention for all included participants and could unveil its potential as an adjunctive therapy for mental health issues after stroke.",[26],"Stroke (Subacute)",[28,29,30],"stroke","virtual reality","anxiety","NOT_YET_RECRUITING","2026-05-20",{"date":34,"type":35},"2026-05-29","ACTUAL",{"date":37,"type":20},"2027-04-01",{"date":39,"type":20},"2029-03-31",{"name":41,"class":42},"Nicolas Nicastro","OTHER",""]