Brain-Computer Interfaces in Laryngeal Dystonia
Key facts
- Who runs it
- Kristina Simonyan
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 18 Apr 2022
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- neurofeedback brain-computer interface (BCI)
- Record updated
- 2 December 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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 predominantly on vowels and strained, strangles quality of voice, predominantly affecting voice production during the speaking. Only patients with the ADLD form of disorder will be recruited to minimize the impact of heterogeneity of voice symptomatology on the outcome of these phase 1 studies
- 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 subjects 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 subjects 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)
Who cannot take part
- 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 for 3-4 months. All patients will be evaluated to ensure that they are fully symptomatic and are at least three months post-injection prior to study participation
- To avoid the possibility of confounding effects of drugs acting upon the central nervous system, all subjects will be questioned about any prescribed or over-the-counter medications as part of their initial screening. Those who are on medication(s) affecting the central nervous system will be excluded
- Subjects 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 diseases; (b) psychiatric problems, such as schizophrenia, bipolar depression, obsessive-compulsive disorder; (c) laryn¬geal problems, such as vocal fold paralysis, paresis, carcinoma
- Subjects 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 denervation-reinnervation. Because both brain and laryngeal surgery may potentially lead to the brain structure and function re-organization, all subjects with a history of brain and/or laryngeal surgery will be excluded from the study
- Subjects 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 negative for study participation
- Subjects 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
- Subjects with implanted deep brain stimulators will be excluded from the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- Massachusetts Eye and Ear InfirmaryBoston, United StatesContact: Kristina Simonyan, MD, PhDTaking people
About the trial
What the trial wants to find out
The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.
The 2 groups in the trial
- Active neurofeedback BCIExisting treatment, for comparison
Patients are presented with symptomatic speech and asymptomatic whisper and, using active EEG-based neurofeedback, are trained to correct their speech by matching their brain patterns to those of whisper. This training is expected to be effective for symptom improvement.
Treatment: neurofeedback brain-computer interface (BCI)
- Sham neurofeedback BCISham treatment, for comparison
Patients are presented with symptomatic speech and asymptomatic whisper and, using sham EEG-based neurofeedback, are trained to correct their speech by matching their brain patterns to those of whisper. This training is expected not to be effective for symptom improvement.
Treatment: neurofeedback brain-computer interface (BCI)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Adaptive Closed-loop Brain-computer Interface Therapeutic Intervention in Laryngeal Dystonia
- Fit questions
- Built from NCT04421365, who can take part
- Record updated
- 2 December 2025