[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615644":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":23,"responsibleParty":39,"collaborators":23,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":23,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":23,"enrollmentInfo":52,"targetDuration":23,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":23,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":23},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Even MRN","Patients with MRNs ending in an even number will undergo their standard BT injections (CN7 muscle groups only) + non-CN7 muscle groups at their first treatment session, followed by standard BT injections alone at their second treatment session.",[12],"Drug: Botulinum Toxin Type A Injection [Botox]",{"label":14,"type":6,"description":15,"interventionNames":16},"Odd MRN","Patients with MRNs that end in an odd number will undergo the reverse injection process (standard BT injections alone at first treatment session, followed by standard BT injections + non-CN7 muscle groups at their second treatment session).",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Botulinum Toxin Type A Injection [Botox]","Patients will receive standard of care synkinesis treatment. Depending on the treatment arm, they will receive additional botox injections to temporalis and masseter muscle groups which will only be injected on the ipsilateral side to the facial nerve injury. Decision to include the temporalis and\u002For masseter muscles will be based on each patients response to screening questions regarding jaw pain\u002Ftightness or headaches.",[9,14],null,[25],{"name":26,"affiliation":27,"role":28},"Priyesh Patel, MD","VUMC","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},"Christine Little, MD","CONTACT","6504555258","christine.little@vumc.org",{"name":36,"role":32,"phone":37,"phoneExt":23,"email":38},"Amy Wang","2818859243","amy.wang@vumc.org",{"type":28,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Priyesh Patel","Assistant Professor","100615644","phase-4-botox-injections-in-non-cranial-nerve-vii-innervated-muscles-for-facial-synkinesis-100615644",false,"NCT07295288","Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis","Investigating the Efficacy of Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis Management","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Current diagnosis of facial synkinesis due to facial nerve paralysis\u002Fparesis.\n* Scheduled to undergo BT injection for management of facial synkinesis.\n* Have undergone \\> 3 prior BT injection sessions at VUMC for facial synkinesis.\n* Able to read and understand English.\n* Symptoms of neck tightness, jaw tightness, or headaches.\n\nExclusion Criteria:\n\n* Cognitive impairment that would preclude the ability to provide informed consent\n* Unable to read text on a written survey or computer screen",true,"ALL","18 Years",{"count":53,"type":54},50,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","Facial synkinesis is a condition that occurs following facial nerve (CN7) injury, typically secondary to Bell's palsy, trauma, surgery (e.g., acoustic neuroma resection), or malignancy. Synkinesis is due to aberrant regeneration of the facial nerve, where axons regrow improperly and result in misdirected innervation of facial muscles. This results in involuntary, uncoordinated muscle movements, where activation of one muscle group triggers unintended contractions in others. Standard treatment of facial synkinesis involves botulinum toxin (BT) injections into muscles controlled by CN7 to reduce these unwanted movements. However, patients often anecdotally report that adding BT injections into non-CN7 innervated muscle groups, such as the masseter and temporalis muscles, improve their synkinesis symptoms. This study therefore aims to assess whether adding BT injections to non-CN7 innervated muscle groups, specifically the masseter and temporalis muscle, can improve treatment outcomes for people with facial synkinesis. This study will use a crossover design, where each participant will serve as their own control to compare treatment effects. In the first treatment arm, patients will receive only their standard BT injections into muscle groups controlled by CN7 - no other muscles will be treated. In the second treatment arm, will receive the same standard BT injections in CN7 muscles, plus additional injections into masseter and temporalis muscles. Patients will be randomized to a specific treatment arm at their first visit. At their second visit, they will be randomized to the other treatment arm, in standard crossover study design. Pre- and post-treatment surveys will be collected to assess the benefit of adding non-CN7 muscle groups.",[60],"Synkinesis",[62],"botulinum toxin","NOT_YET_RECRUITING","2026-04-12",{"date":66,"type":67},"2026-04-15","ACTUAL",{"date":69,"type":54},"2026-07-01",{"date":71,"type":54},"2027-06-30",{"name":5,"class":6}]