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

NCT ID: NCT05506085

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2030-08-01

Brief 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).

Conditions

Laryngeal Dystonia; Adductor Spastic Dysphonia of Dystonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Deep Brain Stimulation

Intervention Type: DEVICE

Deep Brain Stimulation of Globus Pallidus interna

Interventions

Deep Brain Stimulation

Deep Brain Stimulation of Globus Pallidus interna

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Rita R. Patel

Associate Professor, Speech & Hearing Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

S. Elizabeth Zauber, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Kunal Gupta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rita Patel, PhD

Role: CONTACT

patelrir@iu.edu

8128553886

S. Elizabeth Zauber, MD

Role: CONTACT

szauber@iupui.edu

317-963-7437

Facility Contacts

Rita Patel, PhD

Role: primary

patelrir@iu.edu

812-855-3886

S. Elizabeth Zauber, MD

Role: backup

szauber@iupui.edu

317-963-7437

Other Identifiers

14578

Identifier Type: -

Identifier Source: org_study_id