Examining brain function in laryngeal dystonia and voice tremor
Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor
This study is testing how brain function differs in people with laryngeal dystonia and voice tremor compared to healthy individuals to better understand these voice disorders.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| 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 | NCT05216770 on ClinicalTrials.gov |
What this trial studies
This study investigates the neural mechanisms underlying laryngeal dystonia and voice tremor using advanced brain imaging techniques. By comparing the functional neural correlates of these two voice disorders, the researchers aim to identify specific pathophysiological features that differentiate them. The study includes both patients with these disorders and healthy controls to provide a comprehensive understanding of the central nervous system's role in speech production. The approach combines multimodal imaging to capture both spatial and temporal aspects of brain activity during phonation.
Who should consider this trial
Good fit: Ideal candidates include right-handed individuals aged 18-80 with a diagnosis of laryngeal dystonia or voice tremor.
Not a fit: Patients with neurological or psychiatric disorders unrelated to laryngeal dystonia or voice tremor may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnostic and therapeutic strategies for individuals suffering from laryngeal dystonia and voice tremor.
How similar studies have performed: While there have been studies on voice disorders, this specific multimodal approach to understanding the neural pathophysiology of laryngeal dystonia and voice tremor is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Males and females of diverse racial and ethnic background; 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 California San Francisco — 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.