Clinical Assessments for Spasmodic Dysphonia

Overseen By Kristina Simonyan, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: CNS drugs

Disqualifiers: Neurological, psychiatric, laryngeal problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand two voice disorders: laryngeal dystonia (a condition causing involuntary muscle spasms in the voice box) and voice tremor (shaky voice). Researchers will use various voice assessment tools, including clinical assessments of laryngeal function, to identify different patterns of these conditions. The trial includes people with laryngeal dystonia, those with voice tremor, and healthy individuals as controls. It suits those who have either of these voice conditions and have not had recent botulinum toxin treatment. As an unphased trial, this study offers participants the opportunity to contribute to foundational research that could lead to better understanding and future treatments for voice disorders.

Will I have to stop taking my current medications?

If you are taking medications that affect the central nervous system, you will not be able to participate in the trial. The study will ask about all your medications during the initial screening.

What prior data suggests that these clinical voice assessment tools are safe?

Research has shown that tests to evaluate the voice box, which aid in understanding conditions like laryngeal dystonia and voice tremor, are generally safe. These tests allow doctors to assess the voice box's functionality.

For laryngeal dystonia, studies indicate it involves involuntary muscle spasms in the voice box, with no reports of harm from the tests themselves. Similarly, tests for voice tremor measure the severity of the tremor and are well-tolerated by patients.

These tests do not involve experimental drugs or invasive procedures, making them low-risk for participants. Overall, evidence shows that these voice function tests are a safe option for those interested in learning more about their voice conditions through clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand the clinical phenotypes of laryngeal dystonia and voice tremor through detailed clinical assessments of laryngeal function. Unlike standard treatments like Botox injections or oral medications, which focus on managing symptoms, this study seeks to deepen the understanding of these voice disorders at a clinical level. By characterizing how these conditions manifest differently in patients, the trial could pave the way for more personalized and effective treatment approaches in the future.

What evidence suggests that these clinical assessments are effective for evaluating laryngeal dystonia and voice tremor?

This trial will compare patients with laryngeal dystonia, patients with voice tremor, and healthy controls. Research has shown that laryngeal dystonia affects the muscles in the voice box, causing voice problems like shaking and tightness. Many people find relief with Botox treatments, but determining the right dosage can be challenging. Voice tremor, another condition, makes the voice sound unsteady and can complicate speaking. Studies suggest that deep brain stimulation, which uses electrical signals, might improve voice quality for these conditions. Overall, a better understanding of these voice disorders can lead to more effective treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Kristina Simonyan, MD, PhD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

Inclusion Criteria

Males and females of diverse racial and ethnic backgrounds;

Native English speakers;

Right-handed;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Systematic evaluation of clinical voice assessment tools and measures to elucidate distinct clinical phenotypes of laryngeal dystonia and voice tremor

5 years

Follow-up

Participants are monitored for safety and effectiveness after evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical assessments of laryngeal function

How Is the Trial Designed?

Group I: Voice tremor Experimental Treatment 1 Intervention

Patients with voice tremor (essential or dystonic)

Group II: Laryngeal dystonia Experimental Treatment 1 Intervention

Patients with laryngeal dystonia (or spasmodic dysphonia)

Group III: Healthy controls Experimental Treatment 1 Intervention

Healthy research volunteers

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8205448/

Laryngeal Dystonia: Multidisciplinary Update on Terminology ... Both voice tremor and muscle tension dysphonia affect up to one-third of patients with LD and are often misdiagnosed as LD or vice versa. The central vs ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0385814622001535

Spasmodic dysphonia: An overview of clinical features and ... For most patients, BT treatment has proven to be a satisfactory means of achieving relief from symptoms. However, predictable control of voice symptoms may ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05150106

Study Details | NCT05150106 | Characterization of Clinical ... Outcomes of this research will significantly advance our clinical and scientific knowledge regarding optimal clinical tools and measures of LD and VT clinical ...

4. frontierspartnerships.org frontierspartnerships.org/journals/dystonia/articles/10.3389/dyst.2025.15271/full

Is thalamic deep brain stimulation the right target to improve ... The DBS outcomes relevant to voice symptoms were assessed using Voice-Related Quality of Life (V-RQOL), Voice Handicap Index (VHI), and the Unified Spasmodic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11266236/

Demographic and clinical characteristics of our patients ... Laryngeal dystonia (LD) is a focal dystonia affecting laryngeal musculature with no known etiology or cure. The present study evaluated the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2643054/

Research Priorities in Spasmodic Dysphonia - PMC SD symptoms are intermittent spasms in the laryngeal muscles. Current therapies are targeted towards reducing the impact of involuntary muscle spasms on voice.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02061943

Examining the Spasmodic Dysphonia Diagnosis and ... Complete questionnaires regarding the severity of their disorder before and after receiving their usual treatment; an injection of botulinum toxin into the ...

8. sphsc.washington.edu sphsc.washington.edu/measuring-severity-laryngeal-dystonia

Measuring Severity of Laryngeal Dystonia What is the research about? The purpose of the project is to find a better way to measure severity of adductor laryngeal dystonia (adductor spasmodic dysphonia) ...