Recruiting

Observational Study

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT05150106

Conditions

Laryngeal Dystonia

Spasmodic Dysphonia

Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Clinical assessments of laryngeal function

Study Details

Brief summary:

The researchers will systematically evaluate current and novel clinical voice assessment tools and measures to elucidate distinct clinical phenotypes of those with laryngeal dystonia and voice tremor.

Conditions

Laryngeal Dystonia

Spasmodic Dysphonia

Tremor

Study ID

NCT05150106

Start date

Nov 7, 2022

Status verified date

Nov, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

165 participants

Anticipated

Interventions and Outcome Measures

Arms

Laryngeal dystonia

Patients with laryngeal dystonia (or spasmodic dysphonia)

Voice tremor

Patients with voice tremor (essential or dystonic)

Healthy controls

Healthy research volunteers

Interventions

Clinical assessments of laryngeal function

Participants will undergo acoustic, aerodynamic, respiratory kinematic, nasoendoscopic, and laryngeal EMG recordings, as well as real-time MRI of the upper airway for comprehensive characterization of shared and distinct features of laryngeal dystonia and voice tremor.

Primary outcome measure

  • Differences in voice symptoms [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts Eye and Ear and University of Utah

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Julie Barkmeier-Kraemer, PhD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2025-12-02.