Actively Recruiting
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-12-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts Eye and Ear Infirmary
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying neurological voice disorders, such as laryngeal dystonia and voice tremor, in patients with movement disorders like dystonia and essential tremor who are undergoing deep brain stimulation (DBS). The study aims to determine how often these voice disorders occur, explore brain activity and imaging related to voice problems, and evaluate the effects of DBS on voice function. This research focuses on improving understanding of voice control in the brain's motor networks during DBS treatment. The study involves patients diagnosed with dystonia or tremor who are recommended for DBS surgery. During the DBS implantation, simultaneous electrocorticography (ECoG) and subcortical brain activity recordings will be collected while patients are awake and speaking. This approach allows researchers to study brain signals related to voice production during the surgical procedure. The DBS treatment itself is clinically indicated for managing dystonia or tremor. Participants will be evaluated over five years for correlations between brain signals and voice and speech performance during surgery. Clinical outcomes for dystonia and tremor will also be monitored over this period. The study requires participants to complete pre-operative training and tests, and their voice function will be assessed during the surgical and follow-up phases. This research will help develop new brain stimulation strategies to address neurological voice dysfunction.
CONDITIONS
Brief Title
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indications for DBS implantation by a multidisciplinary movement disorders board
- Definitive diagnosis of essential tremor or dystonia
- Medically refractory disease
- Adequate neuropsychological evaluation performance
- Ability to comply with test directions and complete pre-operative training
- Ability to provide informed consent
- Age between 18 and 80 years
You will not qualify if you...
- Inability to understand or perform study tasks during pre-surgery training
- Significant hearing loss
- Cortical venous anatomy obstructing electrode placement as determined by surgeon or imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo deep brain stimulation surgery with simultaneous research electrocorticography (ECoG) while awake and speaking to collect electrophysiological data.
1 surgery visit (in-person)
Duration - Up to 5 years
Participants are monitored for changes in clinical outcomes related to dystonia and tremor over a period of up to 5 years.
Follow-up visits as scheduled for clinical assessments
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital, University of California San Francisco, University of Utah
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
K
Kristina Simonyan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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