[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"voice-tremor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:voice-tremor":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100596111","phase-1-extended-release-sodium-oxybate-lumryz-in-spasmodic-dysphonia-and-voice-tremor-100596111",false,"NCT07041203","Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor","Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study\n3. Males and females\n4. Age 21-80 years\n5. Documented diagnosis of alcohol-responsive laryngeal dystonia\n6. Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies\n7. Willingness to adhere to the study intervention regimen\n\nExclusion Criteria:\n\n1. The incapability of giving informed consent\n2. Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding\n3. Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria\n4. Moderate to severe congestive heart failure\n5. Cognitive impairment (MoCA \\\u003C 26)\n6. Past or present suicidal ideations (according to C-SSRS)\n7. Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria\n8. Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection\n9. Increased daytime sleepiness (Epworth Sleepiness Scale (ESS\\>10))\n10. Past or present history of any neurological disorders (except for LD and co-occurring voice tremor), such as stroke, movement disorders, brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence.\n11. Past or present history of any psychiatric problems, such as schizophrenia, major and\u002For bipolar depression, or obsessive-compulsive disorder\n12. Current use of medication(s) affecting the central nervous system\n13. Past or present history of brain and\u002For laryngeal surgery\n14. Presence of certain tattoos, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that are not MRI comparable and\u002For cannot be removed for the purpose of MRI study participation","ALL","21 Years","80 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Using a comprehensive approach of clinico-behavioral testing and neuroimaging, the researchers will examine the clinical effects of the extended-release formulation of sodium oxybate on voice symptoms in spasmodic dysphonia in an open-label, proof-of-concept, dose-finding study.",[27,28,29],"Spasmodic Dysphonia","Laryngeal Dystonia","Voice Tremor","NOT_YET_RECRUITING","2026-04-25",{"date":33,"type":34},"2026-04-28","ACTUAL",{"date":36,"type":21},"2026-10-01",{"date":38,"type":21},"2027-09-30",{"name":40,"class":41},"Kristina Simonyan","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":42},"100289071","imaging-genetics-of-laryngeal-dystonia-100289071","NCT03042975","Imaging Genetics of Laryngeal Dystonia","Inclusion criteria:\n\n1. Males and females of diverse racial and ethnic background, with age across the lifespan;\n2. Laryngeal Dystonia patients\n\n   * phenotype: adductor or abductor\n   * genotype: familial or sporadic\n3. Voice Tremor patients\n\n   * essential or\n   * dystonic\n4. Muscle tension dysphonia patients\n5. Unaffected relatives of laryngeal dystonia patients with\n\n   * familial laryngeal dystonia\n   * early-onset laryngeal dystonia (onset at ≤ 35 y.o.)\n   * typical onset laryngeal dystonia (onset at ≥ 40 y.o.)\n6. Native English speakers.\n7. Right-handedness.\n8. Normal cognitive status.\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.\n3. Subjects with past or present medical history of (a) major neurological problems, such as stroke, movement disorders (other than LD and VT in the patient groups), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (b) psychiatric problems, such as schizophrenia, bipolar depression, obsessive-compulsive disorder; (c) laryn¬geal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis.\n4. Patients who are not symptomatic due to treatment with botulinum toxin injections into the laryngeal muscles.\n5. Subjects who receive medication(s) affecting the central nervous system.\n6. Subjects with a history of major brain and\u002For laryngeal surgery.\n7. Subjects who have tattoos, ferromagnetic objects in their bodies that cannot be removed for imaging study participation.",{"count":50,"type":21},410,"OBSERVATIONAL","The contribution of genetic risk factors to the development of focal dystonias is evident. However, understanding of how variations in the causative gene expression lead to variations in brain abnormalities in different phenotypes of dystonia (e.g., familial, sporadic) remains limited. The research program of the investigators is set to determine the relationship between brain changes and genetic risk factors in laryngeal dystonia (or spasmodic dysphonia). The researchers use a novel approach of combined imaging genetics, next-generation DNA sequencing, and clinical-behavioral testing. The use of a cross-disciplinary approach as a tool for the discovery of the mediating neural mechanisms that bridge the gap from DNA sequence to the pathophysiology of dystonia holds a promise for the understanding of the mechanistic aspects of brain function affected by risk gene variants, which can be used reliably for the discovery of associated genes and neural integrity markers for this disorder. The expected outcome of this study may lead to better clinical management of this disorder, including its improved detection, accurate diagnosis, and assessment of the risk of developing dystonia in family members.",[28,54,29,55],"Unaffected Relatives of Laryngeal Dystonia Patients","Muscle Tension Dysphonia",[57,58,59,60],"dystonia","spasmodic dysphonia","imaging","genetics","RECRUITING","2025-11-24",{"date":64,"type":34},"2025-12-02",{"date":66,"type":34},"2017-01-23",{"date":68,"type":21},"2028-07-31",{"name":40,"class":41}]