Clinical Trials Logo

Clinical Trial Summary

Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.


Clinical Trial Description

Spasmodic dysphonia (SD), or laryngeal dystonia, is a chronic debilitating condition that selectively affects speech production due to involuntary spasms in the laryngeal muscles. SD often extends beyond the impairment of vocal communication causing significant occupational disability and life-long social isolation. SD becomes even more incapacitating when it is associated with dystonic voice tremor (VT), which is present in about 1/3 of SD patients and is characterized by the inability to sustain a vowel for more than a few seconds. Current treatment of these disorders is limited to the temporary management of voice symptoms with repeated injections of botulinum toxin into the laryngeal muscles. These injections, however, are not fully effective in all SD patients and even less so in combined SD and VT cases. There is, therefore, a critical need to identify alternative therapeutic options that specifically target the pathophysiology of these disorders. On the other hand, the design and the use of such novel therapeutic approaches will be largely unattainable if their central mechanisms of action remain unknown. The objective of this study is to elucidate the primary determinants of clinical response to a novel oral medication, sodium oxybate (Xyrem®), in alcohol-responsive SD and VT patients. Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, we aim to determine the clinical response of SD and VT symptoms to sodium oxybate and identify the primary markers of its clinical benefits. This study will use a controlled experimental design that focuses on detailed characterization of primary effects of a novel oral medication, sodium oxybate, for treatment of SD and VT symptoms. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03292458
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 22, 2018
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06111027 - Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia Phase 1/Phase 2
Withdrawn NCT02061943 - Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change N/A
Recruiting NCT05158166 - DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia Phase 1/Phase 2
Recruiting NCT05580302 - Cortical Silent Period in Laryngeal Dystonia
Recruiting NCT05150106 - Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor
Recruiting NCT05216770 - Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor Early Phase 1
Recruiting NCT05150093 - Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor N/A
Completed NCT00713414 - Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia
Completed NCT01961297 - Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response Phase 2
Completed NCT00118586 - Neuropathology of Spasmodic Dysphonia
Not yet recruiting NCT04938154 - A Phase 2 Trial of Deep Brain Stimulation for Spasmodic Dysphonia Phase 2
Completed NCT02957942 - rTMS in Spasmodic Dysphonia N/A
Completed NCT02558634 - Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial N/A
Terminated NCT00895063 - Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia N/A
Completed NCT05158179 - Assessment of Laryngopharyngeal Sensation in Adductor Spasmodic Dysphonia N/A
Not yet recruiting NCT06078527 - Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort N/A
Enrolling by invitation NCT05892770 - Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia Phase 1/Phase 2
Completed NCT04648891 - Spasmodic Dysphonia Pain Phase 2/Phase 3
Completed NCT03042962 - Brain Networks in Dystonia
Completed NCT03746509 - Laryngeal Vibration for Spasmodic Dysphonia N/A