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New treatment option for Laryngeal Dystonia
Official title Brain-Computer Interfaces in Laryngeal Dystonia
ClinicalTrials.gov ID: NCT04421365
What this study is testing
- What it's testing
- The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.
- Which group you join is decided by chance.
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
- Patients will have clinically documented isolated adductor laryngeal dystonia (ADLD) without any other forms of dystonia or tremor. ADLD causes...
- Healthy controls will be healthy individuals with a negative history of any neurological, psychiatric, or laryngeal problems;
- Age from 18 to 80 years;
- Native English speakers. Non-English-speaking people will not be recruited because brain activation and neural network organization are different...
- Right-handedness (based on Edinburgh Handedness Inventory). Left-handed people will not be recruited because brain activation and neural network...
You likely can't join if
- people who are incapable of giving informed consent will be excluded from the study;
- Pregnant or breastfeeding women until the time they are no longer pregnant or breastfeeding will be excluded from the study. All women of...
- people with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (except for ADLD in the patient...
- people with impaired hearing, vision, and speaking abilities (except for ADLD), as these would most typically have a neurological origin;
- Patients who have dystonia symptoms at rest in order to avoid the potential confound of dystonic spasms occurring during the asymptomatic task...
- Patients who are not symptomatic due to the treatment with botulinum toxin injections into the affected muscles. The duration of positive effects of...
See the full eligibility criteria
- Patients will have clinically documented isolated adductor laryngeal dystonia (ADLD) without any other forms of dystonia or tremor. ADLD causes involuntary spasms during vocal fold adduction, leading to voice breaks...
- Healthy controls will be healthy individuals with a negative history of any neurological, psychiatric, or laryngeal problems;
- Age from 18 to 80 years;
- Native English speakers. Non-English-speaking people will not be recruited because brain activation and neural network organization are different between native and non-native English speakers;
- Right-handedness (based on Edinburgh Handedness Inventory). Left-handed people will not be recruited because brain activation and neural network organization are different between right and left-handed individuals;
- Normal cognitive status (based on Montreal Cognitive Assessment).
- people who are incapable of giving informed consent will be excluded from the study;
- Pregnant or breastfeeding women until the time they are no longer pregnant or breastfeeding will be excluded from the study. All women of childbearing potential will undergo a urine pregnancy test, which must be...
- people with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (except for ADLD in the patient group), brain tumors, ataxias, myopathies, myasthenia gravis, demyelinating...
- people with impaired hearing, vision, and speaking abilities (except for ADLD), as these would most typically have a neurological origin;
- Patients who have dystonia symptoms at rest in order to avoid the potential confound of dystonic spasms occurring during the asymptomatic task production;
- Patients who are not symptomatic due to the 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...
- To avoid the possibility of confounding effects of drugs acting upon the central nervous system, all people will be questioned about any prescribed or over-the-counter medications as part of their initial screening...
- people with implanted deep brain stimulators will be excluded from the study;
- people will be asked whether they have undergone any head and neck surgeries, particularly any brain surgery and laryngeal surgeries, such as thyroplasty, laryngeal denervation, and selective laryngeal adductor...
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.