Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor

Recruiting now · Early Phase 1

Conditions studied: Laryngeal Dystonia, Spasmodic Dysphonia, Tremor

In brief

The researchers will examine functional neural correlates that differentiate between laryngeal dystonia and voice tremor and contribute to disorder-specific pathophysiology using a cross-disciplinary approach of multimodal brain imaging.

Key facts

Study ID

NCT05216770

Run by

Massachusetts Eye and Ear Infirmary

People needed

165

Starts

2022-03-24

Expected to finish

2027-08-31

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females of diverse racial and ethnic background;
• Age 18-80 years;
• Native English speakers;
• Right-handed;
• Normal cognitive status;
• Patients will have laryngeal dystonia or voice tremor;
• Healthy controls will be healthy individuals without neurological, psychiatric or otolaryngological problems.

You may not qualify if…

• Subjects who are incapable of giving informed consent;
• 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;
• 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;
• Patients with any other form of dystonia;
• Patients who have dystonia symptoms at rest or have a presence of mirror dystonia;
• 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;
• 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;
• 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;
• 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 is running

• Massachusetts Eye and Ear and University of California San Francisco — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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