[{"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:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":18,"type":19},48,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25],"Stroke (Subacute)",[27,28,29],"stroke","virtual reality","anxiety","NOT_YET_RECRUITING","2026-05-20",{"date":33,"type":34},"2026-05-29","ACTUAL",{"date":36,"type":19},"2027-04-01",{"date":38,"type":19},"2029-03-31",{"name":40,"class":41},"Nicolas Nicastro","OTHER",""]