| NCT ID | NCT03042962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Spasmodic Dysphonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 141 participants |
| Start Date | 2015-08-01 |
| Primary Completion | 2027-12-31 |
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 141 participants in total. It began in 2015-08-01 with a primary completion date of 2027-12-31.
⚠ 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
To date, there is only limited knowledge about the distinct neural abnormalities that lead to the development of different forms of focal dystonia. The goal of this study is to dissect the pathophysiological mechanisms underlying this clinical phenomenon using multi-level brain network analysis in patients with focal dystonia.
Eligibility Criteria
Inclusion Criteria: * Patients will have clinically documented focal dystonia * Unaffected relatives of patients with focal dystonia * Healthy controls will be healthy volunteers with a negative history of neurological, laryngeal or psychiatric problems * Age from 21 to 80 years. * Native English speakers. * Right-handedness (based on Edinburgh Handedness Inventory). Exclusion Criteria: * Subjects who are incapable of giving an informed consent. * 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, which must be negative for participation in the imaging studies. * Subjects with past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than dystonia in the patient groups), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug depend-ence; (b) psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis. * Patients who are not symptomatic due to treatment with botulinum toxin injections into the laryngeal muscles. The duration of positive effects of botulinum toxin vary from patient to patient but lasts on average for 3-4 months. All patients will be evaluated to ensure that they are fully symptomatic prior to entering the study. * Patients with other forms of dystonia. * Patients who have dystonia symptoms at rest in order to avoid the potential confound of dystonic spasms occurring during the scanning. * To avoid the possibility of confounding effects of drugs acting upon the central nervous system, all study participants will be questioned about any prescribed or over-the-counter medications as part of their initial intake screening. Those patients who receive medication(s) affecting the central nervous system will be excluded from the study. * The patients will be asked whether they have undergone any head, neck, or hand surgeries, which resulted in changes in regional anatomy or innervation. Because brain, hand and laryngeal surgery may potentially lead to the brain structure and function re-organization, all patients with history of brain, hand and/or laryngeal surgery will be excluded from the study. * Subjects who have tattoos, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that cannot be removed for the purpose of study participation.
Contact & Investigator
Kristina Simonyan, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear Infirmary
Frequently Asked Questions
Who can join the NCT03042962 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Spasmodic Dysphonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03042962 currently recruiting?
Yes, NCT03042962 is actively recruiting participants. Contact the research team at Simonyan_Lab@MEEI.HARVARD.EDU for enrollment information.
Where is the NCT03042962 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03042962 clinical trial?
NCT03042962 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Kristina Simonyan, MD, PhD at Massachusetts Eye and Ear Infirmary. The trial plans to enroll 141 participants.