Overview

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

Status:
Not yet recruiting
Trial end date:
2026-08-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborator:
University of California, San Francisco
Treatments:
Bupivacaine
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.