NCT05150106 Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor
| NCT ID | NCT05150106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Laryngeal Dystonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 165 participants |
| Start Date | 2022-11-07 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 165 participants in total. It began in 2022-11-07 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Kristina Simonyan, MD, PhD
STUDY DIRECTOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT05150106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Laryngeal Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05150106 currently recruiting?
Yes, NCT05150106 is actively recruiting participants. Contact the research team at simonyan_lab@meei.harvard.edu for enrollment information.
Where is the NCT05150106 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05150106 clinical trial?
NCT05150106 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Kristina Simonyan, MD, PhD at Massachusetts Eye and Ear. The trial plans to enroll 165 participants.