Actively Recruiting
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Led by Indiana University · Updated on 2025-07-17
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Deep Brain Stimulation (DBS), a neurosurgical procedure, in people with a type of focal dystonia affecting the vocal cords called Adductor Laryngeal Dystonia (ADLD). The study aims to better understand how faulty brain firing patterns cause dystonia and to examine voice outcomes before and after DBS treatment. Participants are individuals who have ADLD and may also have tremors. Participants will undergo DBS surgery targeting the globus pallidus interna as part of their clinical care. Before surgery, they will have specialized testing to study vocal cord movement and functional magnetic resonance imaging (fMRI). During the surgery, brain waves will be recorded using microelectrode recording. After surgery and activation of the DBS device, participants will repeat voice tests, vocal cord imaging, and magnetic resonance imaging (MRI) to assess changes. Throughout the study, participants will have assessments of vocal fold movements, acoustic voice recordings, neuropsychological tests, and speech intelligibility at defined time points before surgery, within 24 hours after surgery, and 6 to 9 months post-surgery. Voice outcomes and brain imaging results will be compared pre- and post-DBS. The study involves careful monitoring of voice and brain function to understand the effects of DBS in treating laryngeal dystonia.
CONDITIONS
Brief Title
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Adductor Laryngeal Dystonia (ADLD) or ADLD with tremor by a laryngologist, speech language pathologist, and neurologist
- Patients undergoing globus pallidus interna (GPi) deep brain stimulation for ADLD with tremor
- Age between 18 and 80 years
- Native speakers of American English
- No evidence of dementia as assessed by a neurologist
- No evidence of severe untreated mood disorder, including specific depression and anxiety score limits
- At least 3 months since last botulinum toxin injection with full symptom return and no residual effects on voice quality
You will not qualify if you...
- Individuals younger than 18 years or older than 80 years
- Women who plan to become pregnant during the study period or are currently breastfeeding
- History of stroke, brain surgery, or other neurological disorders besides the one under study
- Prior laryngeal framework surgeries or other vocal fold disorders
- Patients asymptomatic due to botulinum toxin treatment in vocal folds
- Presence of ferromagnetic or cardiac implants contraindicating MRI
- Gagging or discomfort preventing endoscope placement for larynx visualization
- Dementia, severe depression, or severe anxiety
- Any medical condition or medication that may prevent safe completion of awake brain surgery and research protocols
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.
Duration - Surgery day and immediate recovery period
Participants undergo Deep Brain Stimulation surgery on the Globus Pallidus interna.
1 surgery visit (in-person)
Duration - 6 to 9 months
Participants return for voice outcome assessments, neuropsychological testing, and MRI scans to evaluate changes after surgery.
3 visits: within 24 hours after surgery and at 6 to 9 months after surgery
Trial Site Locations
Total: 1 location
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
R
Rita Patel, PhD
S
S. Elizabeth Zauber, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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