Brain-Computer Interfaces in Laryngeal Dystonia

NCT04421365 | Recruiting FDA Device

• 1 other identifier: 2019P001547
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.

Conditions

Laryngeal Dystonia

Outcome Measures

Primary Outcomes (1)

• Changes in voice symptoms

  Change in the number of dystonic voice breaks as the result of active neurofeedback BCI intervention assessed using perceptual voice analysis

  At the end of day 5 of the intervention

Study Arms (2)

Active neurofeedback BCI

ACTIVE COMPARATOR

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.

Device: neurofeedback brain-computer interface (BCI)

Sham neurofeedback BCI

SHAM COMPARATOR

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.

Device: neurofeedback brain-computer interface (BCI)

Interventions

neurofeedback brain-computer interface (BCI) DEVICE

The integrated components of BCI system include the high-density EEG, 3D-VR, and a built-in ML platform as a real-time neural signal decoder and neurofeedback controller.

Active neurofeedback BCI; Sham neurofeedback BCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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 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 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 implanted deep brain stimulators will be excluded from the study;
• 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.

Sponsors & Collaborators

• Kristina Simonyan: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina Simonyan, MD, PhD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Simonyan, MD, PhD

CONTACT

617-573-6016; simonyan_lab@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head and Neck Surgery

Model Details: Patients will be assigned to active neurofeedback BCI and sham neurofeedback BCI groups to assess the feasibility of the BCI system and the efficacy of neurofeedback.

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: June 9, 2020
• Study Start: April 18, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)