Who is eligible for clinical trial NCT05506085?

Participants must meet the protocol's inclusion criteria for Laryngeal Dystonia. The stated age range is 18 Years to 70 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05506085 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-12

Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application (NCT05506085)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Indiana University

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (10 items).

Location: Indiana University — Indianapolis, Indiana

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

Deep Brain Stimulation (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
Age range of 18-80 years
Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
No evidence for dementia as assessed by neurologist.
No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score \> 29, Beck Anxiety Inventory Score \> 26.
At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Individuals younger than 18 years and older than 80 years of age.
Women who plan to become pregnant during the study period or are currently breastfeeding.
Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
Prior laryngeal framework surgeries or other disorders affecting the vocal folds
Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx
Dementia, severe depression or severe anxiety.
Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Indiana University — Indianapolis, Indiana

📞 Contact the Study Coordinator

Phone: (812) 855-3886

Email: patelrir@iu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Laryngeal Dystonia

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor — Boston, Massachusetts
Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor — Boston, Massachusetts
Brain-Computer Interfaces in Laryngeal Dystonia — Boston, Massachusetts
Effects of Neuromodulation in Laryngeal Dystonia — Boston, Massachusetts
Imaging Genetics of Laryngeal Dystonia — Boston, Massachusetts
tDCS for Laryngeal Dystonia — New Haven, Connecticut

Explore by condition: All Laryngeal Dystonia clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗