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New treatment option for Laryngeal Dystonia
Official title Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor
ClinicalTrials.gov ID: NCT05216770
What this study is testing
What is Laryngeal sensory block with topical bupivacaine?
Laryngeal sensory block with topical bupivacaine is an investigational medicine, being studied as a potential treatment for laryngeal dystonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Males and females of diverse racial and ethnic background;
- Age 18-80 years;
- Native English speakers;
- Right-handed;
- Normal cognitive status;
You likely can't join if
- people who are incapable of giving 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...
- people with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than specified LD and VT in the...
- Patients with any other form of dystonia;
- Patients who have dystonia symptoms at rest or have a presence of mirror dystonia;
- Patients who are not symptomatic due to treatment with botulinum toxin injections into the affected muscles. The duration of positive effects of...
See the full eligibility criteria
- Males and females of diverse racial and ethnic background;
- Age 18-80 years;
- Native English speakers;
- Right-handed;
- Normal cognitive status;
- Patients will have laryngeal dystonia or voice tremor;
- Healthy controls will be healthy individuals without neurological, psychiatric or otolaryngological problems.
- people who are incapable of giving 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 before MRI, which must be negative for...
- people 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...
- Patients with any other form of dystonia;
- Patients who have dystonia symptoms at rest or have a presence of mirror dystonia;
- 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...
- 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...
- 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...
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.