[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stroke-cerebrovascular-accident-ischemic-or-hemorrhagic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stroke-cerebrovascular-accident-ischemic-or-hemorrhagic":29},{"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":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":18,"minAge":68,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":74,"conditions":75,"keywords":82,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":60},"100601636","phase-1-accelerated-rtms-vs-sham-for-stroke-apathy-100601636","NCT07113067","Accelerated rTMS vs. Sham for Stroke Apathy","Accelerated rTMS for Post-stroke Apathy: A Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* 40 years old or greater\n* Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity\n* Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale by the participant or the caregiver\u002Fco-participant (AES) of ≥39\n* Ability to participate in psychometric testing and cognitive tasks\n* Intact cortex at the TMS target site as confirmed by pre-treatment MRI\n* Ability to have a co-participant\u002Fcaregiver who meets the criteria as detailed below.\n\nExclusion Criteria:\n\n* Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage\n* Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)\n* Moderate or severe global aphasia\n* Visual impairment precluding completion of cognitive tasks\n* Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system;\n* Pregnancy (to be later confirmed by UPT in any premenopausal female participants)\n* History of a seizure disorder\n* Preexisting scalp lesion, wound, bone defect, or hemicraniectomy\n* Claustrophobia precluding ability to undergo an MRI\n* Active substance use disorder\n* Psychotic disorders\n* Bipolar 1 Disorder\n* Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)30 or suicide attempt in the previous year\n\nFor CO-PARTICIPANT\u002FCAREGIVER:\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's cognitive and everyday functioning.\n\nExclusion Criteria:\n\n\\- Unable to engage with study procedures in which Co-Participant input is needed.","40 Years",{"count":70,"type":22},40,[72,73],"PHASE1","PHASE2","Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of them. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, investigators are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. This study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). This study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.",[76,77,78,79,29,80,81],"Apathy","Stroke","Stroke Sequelae","Stroke\u002FBrain Attack","Motivation","Abulia",[83,77,84,76,85,80,81,86],"Depression","Stroke Recovery","TMS","Amotivation","2025-10-21",{"date":89,"type":52},"2025-10-22",{"date":91,"type":52},"2025-08-08",{"date":93,"type":22},"2027-06-30",{"name":95,"class":59},"Medical University of South Carolina"]