Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID04421365

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

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

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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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