[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-cervical-dystonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-cervical-dystonia":49},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100610931",false,"NCT07233993","UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]","A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia","CUSTODY","Inclusion Criteria:\n\n* Minimum age 18 years old\n* Clinical diagnosis of Idiopathic Cervical Dystonia\n* On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to screening and expected to be maintained throughout the study\n* Treatment non-naïve to BoNT type A therapy for CD\n* At least 4 months have passed between the last BoNT injection at screening\n* Good clinical response to previous BoNT injections, on stable dosing and treatment scheme\n* Informed Consent as documented by signature.\n* Ability to perform study requirements (to attend assessment and treatments)\n\nExclusion Criteria:\n\n* Diagnosis of other types of Cervical Dystonia (Inherited and Acquired)\n\n  * Concomitant diagnosis of diseases that contraindicate the use of botulinum toxin, such as myasthenia gravis\n  * Known hypersensitivity or allergy to Botulinum-A Toxin\n  * Women who are pregnant or breast feeding\n  * Intention to become pregnant during the study\n  * Lack of safe contraception\n  * Other clinically significant and unstable concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).\n  * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant\n  * Participation in another study with investigational drug within the 30 days preceding and during the present study\n  * Previous enrolment into the current study","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain.\n\nThe main questions it aims to answer are:\n\n* Do ultrasound-guided BoNT injections improve quality of life more than injections without ultrasound?\n* Are ultrasound-guided injections as safe as injections without ultrasound?\n\nResearchers will compare:\n\n* BoNT injections with ultrasound guidance\n* BoNT injections without ultrasound guidance (based only on body landmarks)\n\nParticipants will:\n\n* Receive both types of injections during the study (one first, then the other)\n* Complete questionnaires about quality of life, movement, pain, and mood\n* Attend follow-up visits over about 8 months About 37 adults with cervical dystonia will take part. The study will take place at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy.",[26],"Idiopathic Cervical Dystonia",[28,29,30,31,32,33,34,35,36],"Cervical dystonia","Idiopathic cervical dystonia","Botulinum toxin","BoNT injections","Ultrasound-guided injections","Anatomical landmark","Quality of life","Motor symptoms","Non-motor symptoms","RECRUITING","2026-02-11",{"date":40,"type":41},"2026-02-13","ACTUAL",{"date":43,"type":41},"2025-11-01",{"date":45,"type":20},"2027-12",{"name":47,"class":48},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",""]