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Search / Trial NCT05216770

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

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Jan 11, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to better understand how the brain works in people with laryngeal dystonia and voice tremor. These conditions affect how people speak, and the researchers want to see what differences exist in brain function between those with these disorders and healthy individuals. To do this, they will use advanced brain imaging techniques to gather information that can help improve diagnosis and treatment.

If you are between the ages of 18 and 80, a native English speaker, and right-handed, you may qualify to participate in this study if you have laryngeal dystonia or voice tremor. Healthy volunteers without any neurological or related health issues are also needed. Participants will undergo brain imaging and other assessments, and they should be at least three months post any botulinum toxin treatments for their symptoms before joining the trial. It's important to note that certain medical histories, such as neurological problems or specific surgeries, may exclude you from participating to ensure the study's accuracy.

Gender

ALL

Eligibility 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.

About Massachusetts Eye And Ear Infirmary

Massachusetts Eye and Ear Infirmary is a leading academic medical center specializing in the diagnosis and treatment of eye, ear, nose, and throat disorders. Affiliated with Harvard Medical School, the institution is renowned for its commitment to advancing clinical research and innovative therapies in ophthalmology, otology, and related fields. With a focus on improving patient outcomes, the infirmary conducts a variety of clinical trials aimed at enhancing understanding of diseases and developing cutting-edge treatment options. Its multidisciplinary team of experts collaborates closely with patients and research partners to ensure the highest standards of care and scientific integrity.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Kristina Simonyan, MD, PhD

Study Director

Professor of Otolaryngology - Head and Neck Surgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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