Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04421365
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact Kristina Simonyan, MD, PhD
Phone 617-573-6016
Email simonyan_lab@meei.harvard.edu
Status Recruiting
Phase N/A
Start date April 18, 2022
Completion date August 31, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT06111027 - Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia Phase 1/Phase 2
Withdrawn NCT02061943 - Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change N/A
Recruiting NCT05580302 - Cortical Silent Period in Laryngeal Dystonia
Recruiting NCT05506085 - Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Recruiting NCT05150106 - Characterization of Clinical Phenotypes of Laryngeal Dystonia and Voice Tremor
Recruiting NCT05110417 - Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine Phase 4
Recruiting NCT05216770 - Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor Early Phase 1
Recruiting NCT05150093 - Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor N/A
Recruiting NCT05095740 - Effects of Neuromodulation in Laryngeal Dystonia N/A
Recruiting NCT03042975 - Imaging Genetics of Laryngeal Dystonia
Completed NCT02957942 - rTMS in Spasmodic Dysphonia N/A
Completed NCT02558634 - Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial N/A
Not yet recruiting NCT05467228 - Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia Phase 2
Recruiting NCT05245942 - Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)