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

NCT05506085 | Recruiting DMC

• 1 other identifier: 14578
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (3)

• Change in total number of Vocal fold movements

  Vocal fold movements will be quantified (vibratory breaks + micromotions+ aperiodicities) using high-speed videoendoscopy (HSV) on sustained phonation of the vowel, words, and sentence production. The videoendoscopic recording will be obtained

  Before surgery, within 24 hours after surgery, 6 -9 months after surgery

• Change in Acoustic voice recordings

  Acoustic voice recordings will be obtained using a microphone. Acoustic measurement of voice (voicing percentage) will be obtained from sustained phonation of the vowel /a/, sentences and reading a paragraph.

  Before surgery, within 24 hours after surgery, 6-9 months after surgery

• Microelectrode recording

  Microelectrode recording is performed routinely during DBS (Deep brain stimulation) surgery. The study procedure will be to record voice simultaneously on sustained phonation of the vowels, syllables, and sentences using the data acquisition system NI USM 6221 with a microphone and high-speed videoendoscopy. Beta and theta band power spectral density will be analyzed as measurements.

  during surgery

Secondary Outcomes (6)

• Change in Neuropsychological testing: Trails A

  Before surgery, and 6-9 months after surgery

• Change in Neuropsychological testin: Trails B

  Before surgery, and 6-9 months after surgery

• Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency

  Before surgery, and 6-9 months after surgery

• Change in Resting state Functional Magnetic Resonance Imaging (fMRI)

  before surgery and 6-9 months after surgery

• Change in Voice Handicap Index

  before surgery and 6-9 months after surgery

Study Arms (1)

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

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Deep Brain Stimulation of Globus Pallidus interna

Deep Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting for routine neurology clinic appointments will be screened for clinical DBS (Deep brain stimulation) candidacy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Rita Patel, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• S. Elizabeth Zauber, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Kunal Gupta, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Patel, PhD

CONTACT

8128553886; patelrir@iu.edu

S. Elizabeth Zauber, MD

CONTACT

317-963-7437; szauber@iupui.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Speech & Hearing Sciences

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 18, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (1)