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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05506085
Status
Recruiting
Apply to this trial

Conditions

  • Adductor Spastic Dysphonia of Dystonia
  • Laryngeal Dystonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — DEVICE
    Deep Brain Stimulation of Globus Pallidus interna

Study Details

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).

Key Dates

Start date
Oct 1, 2022
Status verified
Jul 2025
Primary completion
Aug 1, 2030
Completion
Aug 1, 2030

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: Deep Brain Stimulation
    Voice outcomes and Magnetic resonance imaging will be compared pre- and post-DBS (Deep brain stimulation) in patients with laryngeal dystonia and adductor laryngeal dystonia. The evaluators will be masked for analyzing the voice outcomes pre-and post-DBS

Primary Outcome Measure

Change in total number of Vocal fold movements [ Time Frame: Before surgery, within 24 hours after surgery, 6 -9 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Rita Patel, PhD
[email protected]
812-855-3886
S. Elizabeth Zauber, MD
[email protected]
317-963-7437
Stacey Halum, MD (SUB_INVESTIGATOR)
David Kareken, PhD (SUB_INVESTIGATOR)
Amol Yadav, PhD (SUB_INVESTIGATOR)

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Indiana University· Indianapolis, IN

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