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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Indiana
Indiana University
RECRUITING
Indianapolis
Contact Information
Primary
Rita Patel, PhD
patelrir@iu.edu
8128553886
Backup
S. Elizabeth Zauber, MD
szauber@iupui.edu
317-963-7437
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 12
Treatments
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
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Indiana University

This content was sourced from clinicaltrials.gov