[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455915":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":27,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":27,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":27,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8,13,19,23,28],{"label":9,"type":6,"description":10,"interventionNames":11},"Spatial and temporal CNS pathophysiology of laryngeal dystonia and voice tremor","Simultaneous fMRI with EEG and MEG imaging will be used to examine neural dynamics during phonation.",[12],"Other: Brain imaging",{"label":14,"type":15,"description":16,"interventionNames":17},"Sensorimotor modulations of laryngeal dystonia and voice tremor with bupivacaine","ACTIVE_COMPARATOR","Topical laryngeal block (1 ml of 0.75% bupivacaine solution) will be used to modulate somatosensory feedback from the laryngeal mucosa during speech production and examine associated changes in brain activity.",[18],"Drug: Laryngeal sensory block with topical bupivacaine",{"label":20,"type":6,"description":21,"interventionNames":22},"Motor learning and CNS pathophysiology of laryngeal dystonia and voice tremor","Implicit learning of the production of motor sequences will be examined during simultaneous fMRI\u002FEEG and MEG imaging.\n\nSensorimotor adaptation of speech production during MEG imaging will be examined during perturbing pitch or formants of auditory feedback consistently during speech production and examining the behavioral and neural correlates of the resulting across-trial adaptation responses.",[12],{"label":24,"type":25,"description":26,"interventionNames":27},"Placebo effects in laryngeal dystonia and voice tremor","PLACEBO_COMPARATOR","1 ml of saline placebo matching to 1 ml of 0.75% bupivacaine solution will be used for a comparison with the topical laryngeal block to modulate somatosensory feedback from the laryngeal mucosa during speech production and examine associated changes in brain activity.",null,{"label":29,"type":6,"description":30,"interventionNames":31},"Auditory feedback processing in laryngeal dystonia and voice tremor","The role of auditory feedback processing on task-induced speech sensorimotor activity will be examined using MEG imaging during perturbing pitch or formants of auditory feedback, unpredictably during speech production, and examining the behavioral and neural correlates of the resulting within-trial compensation responses.",[12],[33,37],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Brain imaging","Brain images will be conducted with function MRI, magnetoencephalography (MEG), and electroencephalography (EEG) to identify disorder-specific neural markers",[29,20,9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":27},"DRUG","Laryngeal sensory block with topical bupivacaine","Laryngeal sensory block with bupivacaine will be used to modulate sensory feedback from vocal fold mucosa and examine the impact of sensory feedback on abnormal neural activity in LD and VT",[14],[43],{"name":44,"affiliation":45,"role":46},"Kristina Simonyan, MD, PhD","Professor of Otolaryngology - Head and Neck Surgery","STUDY_DIRECTOR",[48],{"name":44,"role":49,"phone":50,"phoneExt":27,"email":51},"CONTACT","617-573-6016","simonyan_lab@meei.harvard.edu",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Massachusetts Eye and Ear and University of California San Francisco","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-71.05977,42.35843,{"lat":65,"lon":64},[68,70,72,74],{"name":44,"role":49,"phone":50,"phoneExt":27,"email":69},"Simonyan_Lab@MEEI.HARVARD.EDU",{"name":44,"role":71,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"name":73,"role":71,"phone":27,"phoneExt":27,"email":27},"Srikantan Nagarajan, PhD",{"name":75,"role":71,"phone":27,"phoneExt":27,"email":27},"John Houde, PhD",{"type":71,"investigatorFullName":77,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Kristina Simonyan",[79],{"name":80,"class":6},"University of California, San Francisco","100455915","early-phase-1-understanding-disorder-specific-neural-pathophysiology-in-laryngeal-dystonia-and-voice-tremor-100455915",false,"NCT05216770","Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor","Inclusion criteria:\n\n1. Males and females of diverse racial and ethnic background;\n2. Age 18-80 years;\n3. Native English speakers;\n4. Right-handed;\n5. Normal cognitive status;\n6. Patients will have laryngeal dystonia or voice tremor;\n7. Healthy controls will be healthy individuals without neurological, psychiatric or otolaryngological problems.\n\nExclusion criteria:\n\n1. Subjects who are incapable of giving informed consent;\n2. Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding. All women of childbearing potential will have a urine pregnancy test performed before MRI, which must be negative for participation in the imaging studies;\n3. Subjects with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than specified LD and VT in the patient groups), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases; (b) psychiatric problems, such as schizophrenia, bipolar depression, obsessive-compulsive disorder, alcoholism, drug dependence; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis;\n4. Patients with any other form of dystonia;\n5. Patients who have dystonia symptoms at rest or have a presence of mirror dystonia;\n6. Patients who are not symptomatic due to treatment with botulinum toxin injections into the affected muscles. The duration of positive effects of botulinum toxin varies from patient to patient but lasts, on average, for 3-4 months. All patients will be evaluated to ensure that they are fully symptomatic and are at least 3 months post-injection before participation;\n7. To avoid the confounding effect of centrally acting drugs, all study participants will be questioned about any prescribed or over-the-counter medications as part of their initial screening. Those patients who receive medication(s) affecting the central nervous system will be excluded;\n8. Patients will be asked whether they have undergone any head or neck surgery, which resulted in changes in regional anatomy or innervation. Because brain or laryngeal surgery may potentially lead to brain structure and function re-organization, all patients with such a history will be excluded;\n9. Subjects who have certain tattoos and ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve) that cannot be removed for MRI studies.",true,"ALL","18 Years","80 Years",{"count":92,"type":93},165,"ESTIMATED","INTERVENTIONAL",[96],"EARLY_PHASE1","The researchers will examine functional neural correlates that differentiate between laryngeal dystonia and voice tremor and contribute to disorder-specific pathophysiology using a cross-disciplinary approach of multimodal brain imaging.",[99,100,101],"Laryngeal Dystonia","Spasmodic Dysphonia","Tremor","2025-11-24",{"date":104,"type":105},"2025-12-02","ACTUAL",{"date":107,"type":105},"2022-03-24",{"date":109,"type":93},"2027-08-31",{"name":5,"class":6},1]