Evaluating voice disorders like laryngeal dystonia and voice tremor
Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor
This study is testing new ways to tell the difference between laryngeal dystonia and voice tremor to help people get the right treatment for their voice disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05150106 on ClinicalTrials.gov |
What this trial studies
This observational study aims to systematically evaluate both current and novel clinical voice assessment tools to identify distinct clinical phenotypes of individuals suffering from laryngeal dystonia (LD) and voice tremor (VT). LD is a rare neurological disorder that disrupts speech, while VT is characterized by a shaky voice quality, often leading to misdiagnosis. The research focuses on accurately differentiating between these disorders to improve treatment planning and management. By utilizing a range of clinical assessments, the study seeks to uncover distinguishing features that can aid in correct diagnosis and classification of these voice disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-80 with diagnosed laryngeal dystonia or voice tremor, as well as healthy controls without neurological or psychiatric issues.
Not a fit: Patients with neurological disorders unrelated to laryngeal dystonia or voice tremor, or those who cannot provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better treatment strategies for patients with laryngeal dystonia and voice tremor.
How similar studies have performed: While this study addresses a critical gap in the understanding of voice disorders, similar approaches have shown promise in other neurological conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Males and females of diverse racial and ethnic backgrounds; 2. Age 18-80 years; 3. Native English speakers; 4. Right-handed; 5. Normal cognitive status; 6. Patients will have laryngeal dystonia or voice tremor; 7. Healthy controls will be healthy individuals without neurological, psychiatric or otolaryngological problems. Exclusion criteria: 1. Subjects who are incapable of giving informed consent; 2. 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; 3. 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; 4. Patients with any other form of dystonia; 5. Patients who have dystonia symptoms at rest or have a presence of mirror dystonia; 6. 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; 7. 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; 8. 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; 9. 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts Eye and Ear and University of Utah — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Kristina Simonyan, MD, PhD
- Email: simonyan_lab@meei.harvard.edu
- Phone: 617-573-6016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.