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
408 weeks
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
Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).
CONDITIONS
Official Title
Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with ADLD and ADLD plus tremor, diagnosed by laryngologist, speech language pathologist, and neurologist
- Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
- Age between 18 and 80 years
- Native speakers of American English
- No evidence of dementia as assessed by neurologist
- No evidence of severe untreated mood disorder, including Beck Depression Inventory-II score > 29 and Beck Anxiety Inventory Score > 26
- At least 3 months since last botulinum toxin injection with full return of symptoms
You will not qualify if you...
- Individuals younger than 18 or older than 80 years
- Women planning pregnancy or currently breastfeeding
- Prior stroke, brain surgery, or other neurological disorders besides ADLD
- Prior laryngeal framework surgeries or other vocal fold disorders
- 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 condition or medication that may prevent safely completing awake brain surgery and research protocols
AI-Screening
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Trial Site Locations
Total: 1 location
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
R
Rita Patel, PhD
CONTACT
S
S. Elizabeth Zauber, MD
CONTACT
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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