Brain-Computer Interfaces in Laryngeal Dystonia
ConditionLaryngeal Dystonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKristina Simonyan
About this trial
The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
neurofeedback brain-computer interface (BCI)
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active neurofeedback BCIActive comparator 1 intervention
Group B: Sham neurofeedback BCISham comparator 1 intervention
Trial outcomes
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
Time frame
At the end of day 5 of the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kristina Simonyan
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
Source ClinicalTrials.gov