[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583247":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":43,"locations":54,"responsibleParty":77,"collaborators":79,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Université du Québec a Montréal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive-psychophysiological therapy (CoPs).","ACTIVE_COMPARATOR","Six therapeutic steps: 1) Awareness training; 2) Profile of high\u002Flow-risk situations for tics; 3) Muscular discrimination; 4) Reduction of sensorimotor activation and modification of action planning style; 5) Cognitive, metacognitive, and behavioral restructuring in high-risk tic situations; 6) Generalization and relapse prevention.\n\nThe individual sessions last 80 minutes: 55 minutes of therapy, 20 minutes of active listening and 5 minutes for a computer activity. The active listening and activity are unrelated to the analyses but ensure that treatment modalities are equivalent in duration and use of a computer. Participants will be informed about the duration of the therapy (10 to 12 sessions weekly) and that its completion requires continuous attendance at the sessions. The program has been adapted for youth with a treatment guide containing examples and exercises tailored for better understanding. Adolescents aged 14 to 17 will receive this manual to support their comprehension.",[13],"Behavioral: Cognitive psychophysiological",{"label":15,"type":16,"description":17,"interventionNames":18},"Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises.","EXPERIMENTAL","After each 55-minute CoPs session (same protocol as arm 1), 25 minutes will be dedicated to biofeedback exercises (80 minutes total). This 25-minute period includes 2 minutes to record the baseline resting level, 15 minutes for the active biofeedback session, and 2 minutes for the second resting measurement.\n\nActive electromyographic (EMG) biofeedback will take the form of computer-generated graphs displayed on a screen at 2 meters (horizontal angle). Changes in muscle activity will cause the movement of a balance with a silvered ball; the graphical feedback of this stimulus is particularly effective in capturing the participant's attention and interactive engagement. The goal is to contract the arm muscle to keep the ball balanced for 5 minutes for each arm, then 5 minutes with both arms (15 minutes).",[19],"Behavioral: Cognitive psychophysiological and Biofeedback",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Cognitive psychophysiological","Focus on the processes influencing thoughts and behaviors underlying tics.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cognitive psychophysiological and Biofeedback","Biofeedback refers to visual exercises that help improve movement control.",[15],[32,36,40],{"name":33,"affiliation":34,"role":35},"Julie Leclerc, Psychology","Université du Québec à Montréal- UQAM","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Marc Lavoie, Psychology","Université TÉLUQ","STUDY_CHAIR",{"name":41,"affiliation":42,"role":39},"Marie-France Marin, Psychology","Université du Québec à Montréal-UQAM",[44,49],{"name":33,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","1-514-987-3000","5267","leclerc.julie@uqam.ca",{"name":50,"role":45,"phone":51,"phoneExt":52,"email":53},"Audrey-Ann Lachance","1-514-323-7260","2381","audrey-ann.lachance.cnmtl@ssss.gouv.qc.ca",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal, Hôpital Rivières-des-Prairies","RECRUITING","Montreal","Quebec","H1E 1A4","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-73.58781,45.50884,{"lat":67,"lon":66},[70,74,76],{"name":71,"role":45,"phone":72,"phoneExt":73,"email":48},"Julie Leclerc","514-323-7260","2190",{"name":50,"role":45,"phone":75,"phoneExt":52,"email":53},"5143237260",{"name":71,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":71,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Full professor, psychology department, UQAM. Researcher & Mental Health Research Director, Centre intégré universitaire santé et services sociaux (CIUSSS) Nord-de-l'Île-de-Montréal. Associate Researcher, Institut Universitaire Santé Mentale de Montreal",[80],{"name":81,"class":6},"Ciusss de L'Est de l'Île de Montréal","100583247","cognitive-psychophysiological-treatment-for-tics-in-young-people-with-tourettes-syndrome-with-or-without-biofeedback-100583247",false,"NCT06873841","Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback","Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial","CoBRa","Inclusion Criteria:\n\n* Have a diagnosis of TS or to experience bothersome tics;\n* Be aged 14 to 21 years inclusive at the start of therapy.\n\nExclusion Criteria:\n\n* Present a sensorimotor impairment;\n* Have a diagnosis of intellectual disability (intelligence quotient below 75);\n* Alcohol or drug abuse;\n* A neurological issue (e.g., hemifacial spasms, Huntington's disease);\n* Change medication one month or less before step 1 and up to step 4 (last measurement time) without informing a member of the research team;\n* Simultaneously receive another intervention for tics (e.g., psychologist, massage therapist) without informing a research team member.","ALL","14 Years","21 Years",{"count":94,"type":95},150,"ESTIMATED","INTERVENTIONAL",[98],"NA","The goal of this clinical trial is to compare the effectiveness of CoPs therapy with or without the therapeutic component of biofeedback in treating tics in Tourette Syndrome with emerging young adults.\n\nHypotheses:\n\n1. The CoPs+Biofeedback treatment will improve the severity of tics (YGTSS) and the Clinical Global Impression, surpassing the clinical significance threshold of CoPs treatment alone.\n2. We expect that the identified variables (psychosocial, neurocognitive, biological) will predict the improvement of tics.\n\nResearchers will compare if the biofeedback treatment will improve the severity of tics.\n\n* In the pre-test, participants will undergo two interviews, each lasting 3 hours. These interviews will assess (through a battery of tests) the severity of tics as well as the psychosocial, biological, and neurocognitive aspects of functioning. A general assessment of intelligence and executive functions will also be conducted.\n* They will next attend 10 to 12 therapy sessions, with or without biofeedback. (The biofeedback component is explained in more detail in the ''Study Design'' section).\n* The post-test follow-ups consist of two evaluations: one 3 months after the end of the treatment and the other 6 months after. The evaluation will be done using the same battery of tests as during the pre-test interview.",[101,102,103],"Tourette Syndrome","Tics","Tourette Syndrome in Adolescence",[105,106,107,108,109,102,110],"CoPs","Biofeedback","cognitive-psychophysiological therapy","Tourette","Young adults","Treatment","2025-07-04",{"date":113,"type":114},"2025-07-08","ACTUAL",{"date":116,"type":114},"2025-04-15",{"date":118,"type":95},"2029-12",{"name":5,"class":6},1]