Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

NCT ID: NCT05150093

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2027-08-31

Brief Summary

The goals of this project are 1) to determine the incidence of neurological voice disorders in patients with dystonia and essential tremor undergoing deep brain stimulation (DBS), 2) investigate the neuroimaging and intracranial neurophysiology correlates of voice dysfunction in these subjects, and subsequently 3) determine the effects of DBS on voice function.

Detailed Description

Loss of voice control, which is critical for conveying effective spoken communication, is often a significant feature in patients with movement disorders, such as dystonia and essential tremor. Voice dysfunction, however, has been overshadowed clinically by a focus on limb motor symptoms. For example, deep brain stimulation (DBS) effectively reduces limb dystonia and tremor in these patients, but the modulation of voice symptoms by DBS has been vastly understudied. It is assumed that the production and modulation of voice are regulated by the basal ganglia-thalamo-cortical network in a loop architecture that is common to all motor behaviors. There is, however, little empirical data to inform our specific understanding of how voice function is encoded in basal ganglia-thalamo-cortical interactions. The overall goal of this research is to use a combination of invasive and non-invasive human neuroscience to improve our understanding of the incidence and neural correlates of neurological voice disorders (laryngeal dystonia and voice tremor) in patients with isolated dystonia and essential tremor undergoing DBS surgery. The investigators will use simultaneous electrocorticography (ECoG) and subcortical activity recording in dystonia and tremor patients who are awake and speaking during DBS implantation surgery. The results of this research will inform the development of strategies for closed-loop brain stimulation specifically to treat neurological voice dysfunction that can be tested in a subsequent clinical trial.

Conditions

Laryngeal Dystonia; Spasmodic Dysphonia; Tremor; Dystonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Electrophysiological signal data collection

Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: PROCEDURE

Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).

Interventions

Deep Brain Stimulation

Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Clinical indications to proceed with DBS implantation, as determined by the clinical multidisciplinary movement disorders board, including: a) definitive diagnosis of essential tremor or dystonia, b) medically refractory disease, c) adequate performance on neuropsychological evaluation as determined by a licensed clinical neuropsychologist.

2. The ability to comply with test directions, complete pre-operative task training, and provide informed consent.

3. Age 18-80 years.

Exclusion

1. Inability to understand or perform the task outlined in the protocol during a pre-surgery training session. 2. Significant hearing loss.

3. Cortical venous anatomy that could potentially obstruct ECoG electrode placement, as determined by the surgeon, visualized on pre-op MRI or during surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

UMass Memorial Health

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Kristina Simonyan

Professor of Otolaryngology - Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristina Simonyan, MD, PhD

Role: STUDY_DIRECTOR

Massachusetts Eye and Ear

Locations

Massachusetts General Hospital, University of California San Francisco, University of Utah

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristina Simonyan, MD, PhD

Role: CONTACT

simonyan_lab@meei.harvard.edu

617-573-6016

Facility Contacts

Kristina Simonyan, MD, PhD

Role: primary

simonyan_lab@meei.harvard.edu

617-573-6016

Other Identifiers

2021P003236

Identifier Type: -

Identifier Source: org_study_id