Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Dystonia Clinical Trial

Official title:

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150093
• Other study ID #: 2021P003236
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2023
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Kristina Simonyan, MD, PhD
• Phone: 617-573-6016
• Email: simonyan_lab[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion

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.

Related Conditions & MeSH terms

• Dysphonia
• Dystonia
• Dystonic Disorders
• Laryngeal Dystonia
• Spasmodic Dysphonia
• Tremor

Intervention

Procedure:
• Deep Brain Stimulation
Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital, University of California San Francisco, University of Utah	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Massachusetts General Hospital, University of California, San Francisco, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlations between brain signals and intraoperative voice and speech production performance.	Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.	5 years
Primary	Changes in standard clinical outcome for dystonia patients	Quantitative measures of voice and motor changes following deep brain stimulation surgery using standard clinical criterion of Burk-Fahn-Marsden Dystonia Rating Scale where higher score means a worse outcome.	5 years
Primary	Changes in standard clinical outcome for tremor patients	Quantitative measures of voice and motor changes following deep brain stimulation surgery using standard clinical criterion of Fahn-Tolosa-Marin Tremor Rating Scale where higher score means a worse outcome.	5 years