[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522061":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":29,"responsibleParty":50,"collaborators":29,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":29,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":75,"whyStopped":29,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":29},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"4 weeks phase A arm","EXPERIMENTAL","Phase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes.\n\nPhase B = therapeutic education with tDCS for 4 weeks\n\nPhase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.\n\nPhase D = follow-up",[13,14,15],"Other: therapeutic education","Other: tDCS","Other: cognitive remediation",{"label":17,"type":10,"description":18,"interventionNames":19},"5 weeks phase A arm","Phase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes.\n\nPhase B = therapeutic education with tDCS for 4 weeks\n\nPhase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.\n\nPhase D = follow-up",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"6 weeks phase A arm","Phase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes.\n\nPhase B = therapeutic education with tDCS for 4 weeks\n\nPhase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.\n\nPhase D = follow-up",[13,14,15],[25,30,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"therapeutic education","The themes covered concern head trauma in the chronic phase.",[9,17,21],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"tDCS","The constant electric current will be delivered at an intensity of 2 mA for 20 minutes.The anode will be placed opposite the dorsolateral prefrontal area on the right. The cathode (or reference electrode) will be positioned opposite the supraorbital area on the left. This methodology is based on the general directions and results from scientific studies which aimed to improve the efficiency of neural networks engaged in attentional processes and working memory.",[9,17,21],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"cognitive remediation","Personalized sessions combining 2 approaches:•Retraining deficit components of working memory.exercise the strengthening of metacognition and the learning of \"reorganization-facilitation\" strategies. At the end of each exercise, the participant will be asked to analyze their performance and will benefit from feedback from the rehabilitator as well as a discussion on the use of the strategies. Finally, all of the proposed tasks will be made up of several levels of complexity; moving to a more complex stage will require more than 90% success in the exercise.•More ecological exercises will also be carried out in order to get as close as possible to the difficulties encountered by the patient on a daily basis. The examiner will guide the rehabilitation and propose tasks imitating his daily life.",[9,17,21],[39],{"name":40,"affiliation":5,"role":41},"Adeline Julien","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":29,"email":46},"CONTACT","05 61 77 97 21","julien.ade@chu-toulouse.fr",{"name":48,"role":44,"phone":29,"phoneExt":29,"email":49},"Clemence Le Bervet","lebervet.c@chu-toulouse.fr",{"type":51,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100522061","cognitive-remediation-of-working-memory-post-head-trauma-100522061",false,"NCT06077695","Cognitive Remediation of Working Memory Post Head Trauma","Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.","Meta-SCED","Inclusion Criteria:\n\n* Moderate or severe head trauma, defined by an initial Glasgow score ≤ 12\u002F15, duration of post-traumatic amnesia superior to 24 hours and\u002For the presence of abnormalities on brain imaging,\n* Moderate or severe head trauma occurring within a period greater than or equal to 3 months,\n* Working memory complaints assessed by the Working Memory Questionnaire,\n* Patients with a working memory disorder in at least one of the following tests: Digit Memory subtest WAIS-IV (standard deviation ≤ -2) , PASAT (percentile ≤ 10), Brown-Peterson (standard deviation ≤ -2).\n\nExclusion Criteria:\n\n* Presence of aphasia, apraxia or severe neglect demonstrated by standardized neuropsychological tests during the inclusion visit: language - oral naming of BECS-GRECO images, ideational praxis and ideomotor , neglect - bell test,\n* Insufficient visual or auditory abilities and oral and written expression to carry out neuropsychological tests,\n* Severe depression assessed by the Beck Depression Inventory (BDI)\n* Chronic alcoholic poisoning, drug addiction,\n* Progressive general illness,\n* Progressive psychiatric or neurological condition leading to cognitive impairment,\n* Hospitalization for a neurological pathology since the acute phase of the qualifying event,\n* Patient requiring surgery during study participation.\n* Pregnant or breastfeeding women","ALL","18 Years","60 Years",{"count":64,"type":65},9,"ESTIMATED","INTERVENTIONAL",[68],"NA","Patients with working memory deficits due to a moderate to severe head injury will undergo a 5 month protocol including cognitive remediation with numerous exercises, transcranial direct current stimulation (tDCS), and therapeutic education.",[71],"Head Trauma",[73,35,74],"working memory","transcranial direct current stimulation","NOT_YET_RECRUITING","2024-06-14",{"date":78,"type":79},"2024-06-17","ACTUAL",{"date":81,"type":65},"2024-12-30",{"date":83,"type":65},"2025-12-30",{"name":5,"class":6}]