Evaluating voice disorders like laryngeal dystonia and voice tremor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Deep Brain Stimulation for Voice Disorders in Dystonia and Tremor

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• How gentle vibration to the throat affects brain activity in people with laryngeal dystonia

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• Deep cerebellar nucleus stimulation for refractory tremor

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• Using brain stimulation to reduce tremors in Parkinson's disease

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  Recruiting Universitätsklinikum Hamburg-Eppendorf · Hamburg, Free and Hanseatic City of Hamburg · NCT06993571

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.