[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kristina Simonyan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,67],{"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":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100394845","brain-computer-interfaces-in-laryngeal-dystonia-100394845","NCT04421365","Brain-Computer Interfaces in Laryngeal Dystonia","Adaptive Closed-loop Brain-computer Interface Therapeutic Intervention in Laryngeal Dystonia","Inclusion criteria:\n\n1. Patients will have clinically documented isolated adductor laryngeal dystonia (ADLD) without any other forms of dystonia or tremor. ADLD causes involuntary spasms during vocal fold adduction, leading to voice breaks predominantly on vowels and strained, strangles quality of voice, predominantly affecting voice production during the speaking. Only patients with the ADLD form of disorder will be recruited to minimize the impact of heterogeneity of voice symptomatology on the outcome of these phase 1 studies;\n2. Healthy controls will be healthy individuals with a negative history of any neurological, psychiatric, or laryngeal problems;\n3. Age from 18 to 80 years;\n4. Native English speakers. Non-English-speaking subjects will not be recruited because brain activation and neural network organization are different between native and non-native English speakers;\n5. Right-handedness (based on Edinburgh Handedness Inventory). Left-handed subjects will not be recruited because brain activation and neural network organization are different between right and left-handed individuals;\n6. Normal cognitive status (based on Montreal Cognitive Assessment).\n\nExclusion criteria:\n\n1. Subjects who are incapable of giving informed consent will be excluded from the study;\n2. Pregnant or breastfeeding women until the time they are no longer pregnant or breastfeeding will be excluded from the study. All women of childbearing potential will undergo a urine pregnancy test, which must be negative for study participation;\n3. Subjects with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (except for ADLD in the patient group), brain tumors, ataxias, myopathies, myasthenia gravis, demyelinating diseases; (b) psychiatric problems, such as schizophrenia, bipolar depression, obsessive-compulsive disorder; (c) laryn¬geal problems, such as vocal fold paralysis, paresis, carcinoma;\n4. Subjects with impaired hearing, vision, and speaking abilities (except for ADLD), as these would most typically have a neurological origin;\n5. Patients who have dystonia symptoms at rest in order to avoid the potential confound of dystonic spasms occurring during the asymptomatic task production;\n6. Patients who are not symptomatic due to the 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 three months post-injection prior to study participation;\n7. To avoid the possibility of confounding effects of drugs acting upon the central nervous system, all subjects will be questioned about any prescribed or over-the-counter medications as part of their initial screening. Those who are on medication(s) affecting the central nervous system will be excluded;\n8. Subjects with implanted deep brain stimulators will be excluded from the study;\n9. Subjects will be asked whether they have undergone any head and neck surgeries, particularly any brain surgery and laryngeal surgeries, such as thyroplasty, laryngeal denervation, and selective laryngeal adductor denervation-reinnervation. Because both brain and laryngeal surgery may potentially lead to the brain structure and function re-organization, all subjects with a history of brain and\u002For laryngeal surgery will be excluded from the study.",true,"18 Years",{"count":53,"type":21},40,[55],"NA","The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.",[28],"RECRUITING","2025-11-24",{"date":61,"type":34},"2025-12-02",{"date":63,"type":34},"2022-04-18",{"date":65,"type":21},"2027-08-31",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"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":74,"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.",[28,78,29,79],"Unaffected Relatives of Laryngeal Dystonia Patients","Muscle Tension Dysphonia",[81,82,83,84],"dystonia","spasmodic dysphonia","imaging","genetics",{"date":61,"type":34},{"date":87,"type":34},"2017-01-23",{"date":89,"type":21},"2028-07-31",{"name":40,"class":41},""]