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Adaptive Closed-loop Brain-computer Interface Therapeutic Intervention in Laryngeal Dystonia
The researchers will develop and evaluate the use of adaptive closed-loop brain-computer interface therapeutic intervention in laryngeal dystonia.
Dystonia is a neurological disorder, which causes involuntary, sustained muscle contractions, resulting in uncontrollable twisting, repetitive movements, and abnormal postures. Selective impairment of motor control of highly skilled and goal-oriented behaviors is the defining feature of task-specific focal dystonias. Among these, laryngeal dystonia (LD) is characterized by involuntary spasms in laryngeal muscles, which selectively occur during speaking but not whispering, crying, or laughing. As speech communication is a vital part of our daily existence, LD symptoms have a deeply pervasive effect on the quality of life of the affected individual, often extending beyond speech motor deficits and causing significant occupational disability, psychiatric comorbidities, long-lasting stress, and social isolation. Despite the chronic, debilitating impact of LD, its clinical management remains stagnant. The overall objective of this study is to conduct a randomized, sham-controlled, parallel design, phase 1 clinical trial to assess the feasibility and efficacy of a neurofeedback brain-computer interface (BCI) paradigm in LD patients that acts upon and modulates the disorder pathophysiology. The rationale for the proposed studies is that delineation of task-specific neural alterations for their feasible utilization as a pathophysiological target of therapeutic intervention will establish a robust scientific foundation for the development of novel strategies for LD treatment, inform the conduct of the next phase of the clinical trial, and directly contribute to closing the existing critical gap in the clinical management of this disorder.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Start Date
April 18, 2022
Primary Completion Date
August 31, 2027
Completion Date
August 31, 2027
Last Updated
December 2, 2025
40
ESTIMATED participants
neurofeedback brain-computer interface (BCI)
DEVICE
Lead Sponsor
Kristina Simonyan
NCT05150106
NCT06111027
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05580302