[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cerebral-anoxia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cerebral-anoxia":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100469490","regulating-emotions-and-behaviors-after-brain-injury-100469490",false,"NCT05393492","Regulating Emotions and Behaviors After Brain Injury","Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study","GREMO-LCA","Eligibility Criteria: \\* (Limit: 15,000 characters)\n\nSummary criteria for participant selection.\n\nMain eligibility criteria\n\nGREMO patients :\n\n* Inclusion criteria:\n\n  * Persons with acquired brain injury regardless of the type or location of the injury\n  * Age between 18 and 68\n  * Over 18 months since the acquired brain injury (or 6 month if mild traumatic brain injury)\n  * Challenging behaviors or emotional dysregulation or high level of anxiety \u002F depression or family's complaints about emotional dysregulation\n  * Secondary or exacerbated by an acquired brain injury\n  * Causing important suffering for themselves or their families\n  * Being affiliated to a social security\n  * Fluent in French\n  * Being able to understand goals and risks and to give a dated and signed consent\n* Exclusion criteria:\n\n  * Clinically evident severe lack of insight, lack of abstract reasoning, or severe anosognosia\n  * Patients without any complaints\n  * Severe cognitive impairments, aphasia or intellectual impairments that doesn't allow to understand DBT skills, questionnaires or group intreactions\n  * Non fluent in French\n  * Associated brain degenerative disease\n  * Cancerous brain injury with uncertain progression\n  * Non-stabilized psychotic disorder\n  * Following a third wave cognitive behavioral therapy during the research study (for example : acceptance and commitment therapy)\n\nControls without brain injury\n\n* Inclusion criteria :\n\n  * Being 18 years old or more\n  * Without brain injury\n* Exclusion criteria :\n\n  * Non fluent in French\n  * History of brain injury or brain disease\n  * History of psychiatric disorder\n  * Personality disorder\n  * GREMO patient's family member living together\n  * Psychologist, neuropsychologist or people with an emotional regulation knowledge linked to their profession\n  * Being under guardianship or curatorship\n  * Being pregnant or breastfeeding\n\nGREMO patients' family members\n\n* Inclusion criteria :\n\n  * Being 18 years old or more\n  * GREMO patient's family member\n  * Living with a GREMO patient\n  * Agreeing to rate an emotion-behavior-skills diary cards\n* Exclusion criteria :\n\n  * GREMO patient's refusal for their family member to participate\n  * Non fluent in French\n  * Brain injury or brain disease\n  * Major lack of insight\n  * Being under trusteeship or curatorship\n\nQualitative research ABI patients and families\n\n* Inclusion criteria :\n\n  * Person with ABI attending the same medico-social service as GREMO patients\n  * Ineligible for GREMO patients group (participation refusal, major insight difficulty…)\n  * Agreeing to talk about their free will or spirituality\n* Exclusion criteria :\n\n  * Aphasia or dysarthria not allowing understandable recording\n  * Impossibility to understand oral questions\n  * Non fluent in French",true,"ALL","18 Years",{"count":21,"type":22},77,"ESTIMATED","INTERVENTIONAL",[25],"NA","After acquired brain injury (ABI), persons can experience emotional and behavioral difficulties, that can be painful both for the person and his\u002Fher family. This clinical study aims at measuring the effectiveness of a third wave cognitive behavioral therapy called \"dialectical behavior therapy\" (DBT). DBT aims at teaching persons emotion regulation skills, interpersonal effectiveness skills, mindfulness and distress tolerance skills through group and individual sessions.\n\nThe study's hypothesis is that DBT, in an adapted format for persons with ABI can lead to\n\n* a better quality of life, emotional and behavioral regulation, and self-esteem\n* decrease in problematic behaviors\n* progress in life goals\n* increase post traumatic growth and spirituality\n* better family functioning and lesser burden for care givers\n* experiencing more emotions and more free will\n\n  45 persons with an ABI sustained more than 18 month back, will follow a 3 phases, follow-up with care as usual for 5 months, followed by 5 months of DBT, followed by 5 months of care as usual + DBT monthly sessions.\n\nSelf- and family-questionnaire will explore quality of life, emotional regulation, self-esteem, stress, anxiety, cognitive difficulties, family functioning and coping, post traumatic growth and spirituality and will be compared across the 3 phases. Results will be analyzed at a group level but also at an individual level (each patient separately) to test for decrease in unwanted behaviors and at a dyadic level (the person and his\u002Fher spouse) to test for the mutual effect of regulating emotions. Persons' memories will by analyzed at 3 time points by a linguistic analysis, and experience of free will after ABI will be analyzed by transcribed narratives of participants.",[28,29,30,31,32,33],"Acquired Brain Injury","Stroke\u002F Cerebrovascular Accident (Ischemic or Hemorrhagic)","Brain Tumor (After Recovery)","Encephalitis","Cerebral Anoxia","Meningitis",[35,36,37,38,39,40,41,42,43,44,45,46,47],"brain injury","dialectical behavior therapy","emotions","emotional dysregulation","behavioral disorders","spirituality","challenging behaviors","linguistic markers","emotional distress","family burden","free will","interpretative phenomenological analysis","single-case experimental design","RECRUITING","2026-06-05",{"date":51,"type":52},"2026-06-09","ACTUAL",{"date":54,"type":52},"2022-05-19",{"date":56,"type":22},"2028-12",{"name":58,"class":59},"University Hospital, Strasbourg, France","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":18,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":80,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100597847","neo-reeduc---mixed-reality-for-motor-rehabilitation-a-prospective-multicenter-controlled-randomized-open-study-100597847","NCT07063810","NEO-REEDUC - Mixed Reality for Motor Rehabilitation: a Prospective, Multicenter, Controlled, Randomized, Open Study.","Inclusion Criteria:\n\n\\- Adult patient (18 years old or older) with motor disorders related to a deficit in postural stability (mini-BESTest ≤ 25) which may be associated with a deficit in the use of upper limbs and locomotion, consecutive to : 1) either acquired neurological impairments (ischemic or hemorrhagic stroke in sub-acute or chronic phase, head trauma, benign tumor operated on with complete removal, cerebral anoxia) , or 2) a neurodegenerative affection (Parkinson's disease, Multiple Sclerosis).\n\nOR\n\n* Child or teenager patient (6 to 17 years old) with motor disorders related to a deficit in postural stability (mini-BESTest ≤ 25) which may be associated with a deficit in the use of upper limbs and locomotion, consecutive to 1) either spastic, dyskinetic or ataxic cerebral palsy, or 2) a similar impairment without diagnosis or of another etiology.\n* Patient able to walk with or without technical aids and to perform voluntary upper limb movements.\n* Patient able to understand and follow instructions or adapted communication.\n* Patient having given written informed consent concerning his\u002Fher participation in the protocol OR (for children) whose parents have given their written informed consent.\n* Patient covered by social security.\n\nExclusion Criteria:\n\n* Patient with a severe intellectual disability.\n* Patient with a severe attention deficit disorder.\n* Patient whose epilepsy is not stable.\n* Patient with pain preventing participation in the intended tasks of the protocol.\n* Patient with an illness, medical condition or treatment incompatible with participation in the protocol.\n* Patient with multiple sclerosis with relapse less than 3 months old.\n* Simultaneous participation in other interventional research (1) that may exclude participation in the present study or (2) for which the exclusion period has not ended and whose nature may possibly impact the results of the present research.\n\nIn addition, the vulnerable persons mentioned in Articles L. 1121-5, L.1121-6 and L.1121-8 of the French Public Health Code are excluded from the study:\n\n* Pregnant, nursing or parturient women.\n* Persons deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.\n* Adults under legal protection or unable to express their consent.","6 Years",{"count":69,"type":22},120,[25],"This study aims to assess the effectiveness of a motor rehabilitation protocol that includes mixed reality activities, compared to conventional rehabilitation, on postural stability in children and adult patients with neurological impairments.",[73,74,75,76,77,78,79,32],"Neurological Conditions","Brain Diseases","Cerebral Palsy","Parkinson Disease (PD)","Multiple Sclerosis","Head Trauma","Ischemic Stroke",[81,73,82,83,84,85],"Mixed Reality","Motor Rehabilitation","Postural Stability","Upper Limb","Locomotion","NOT_YET_RECRUITING","2025-07-02",{"date":89,"type":52},"2025-07-14",{"date":91,"type":22},"2025-07-10",{"date":93,"type":22},"2025-12-31",{"name":95,"class":59},"Slb Pharma",5]