Actively Recruiting
Adaptive Closed-loop Brain-computer Interface Therapeutic Intervention in Laryngeal Dystonia
Led by Kristina Simonyan · Updated on 2025-12-02
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new adaptive closed-loop brain-computer interface (BCI) therapy for people with laryngeal dystonia (LD), a neurological disorder that causes involuntary muscle spasms in the voice box during speaking. This condition disrupts speech and severely impacts quality of life through communication difficulties, occupational disability, and social isolation. The trial is a randomized, sham-controlled phase 1 study designed to explore how this BCI treatment might modulate the brain patterns involved in LD and inform future therapies. The study involves two groups of participants with LD. One group receives active EEG-based neurofeedback training where they use the BCI system to adjust their brain activity during speaking to resemble that during whispering, which is symptom-free. The comparison group receives sham neurofeedback training using a similar setup but without effective brain activity correction. The BCI system combines high-density EEG, 3D virtual reality, and machine learning to decode neural signals in real time during these sessions. Participants will undergo a five-day intervention during which their voice symptoms and brain activity are monitored. Researchers will assess changes in voice symptoms at the end of the intervention to evaluate the therapy's potential effects. The study includes detailed cognitive and neurological assessments, and participants are screened for other health conditions that could interfere with the results. The trial runs until August 2027 and includes adults aged 18 to 80 years who meet specific clinical and language criteria.
CONDITIONS
Brief Title
Brain-Computer Interfaces in Laryngeal Dystonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with clinically documented isolated adductor laryngeal dystonia (ADLD) without other dystonia or tremor forms
- Healthy controls with no history of neurological, psychiatric, or laryngeal problems
- Age between 18 and 80 years
- Native English speakers
- Right-handed individuals (based on Edinburgh Handedness Inventory)
- Normal cognitive status (based on Montreal Cognitive Assessment)
You will not qualify if you...
- Unable to give informed consent
- Pregnant or breastfeeding women until no longer pregnant or breastfeeding; negative pregnancy test required for women of childbearing potential
- History of neurological issues such as stroke, other movement disorders (except ADLD), brain tumors, ataxias, myopathies, myasthenia gravis, demyelinating diseases
- History of psychiatric disorders including schizophrenia, bipolar depression, obsessive-compulsive disorder
- Laryngeal problems like vocal fold paralysis, paresis, carcinoma
- Impaired hearing, vision, or speaking abilities not related to ADLD
- Presence of dystonia symptoms at rest
- Currently asymptomatic due to botulinum toxin treatment; must be fully symptomatic and at least three months post-injection
- Use of medications affecting the central nervous system
- Implanted deep brain stimulators
- History of brain or laryngeal surgery including thyroplasty, laryngeal denervation, or selective laryngeal adductor denervation-reinnervation surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive neurofeedback brain-computer interface training to help correct their speech by matching their brain patterns to those of whisper. This intervention lasts for 5 days.
Daily visits for 5 days (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
K
Kristina Simonyan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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