Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Not Applicable

Recruiting

• Conditions: Dystonia; Tremor; Laryngeal Dystonia; Spasmodic Dysphonia
• Interventions: Procedure: Deep Brain Stimulation

• Registration Number: NCT05150093
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

Study Timeline

• Study First Submitted: 2021-11-27
• Study First Submitted QC: 2021-11-27
• Study First Posted: 2021-12-08
• Study Start: 2022-06-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrophysiological signal data collection	Deep Brain Stimulation	Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.

Primary Outcome Measures

Name	Time	Method
Correlations between brain signals and intraoperative voice and speech production performance.	5 years	Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.
Changes in standard clinical outcome for dystonia patients	5 years	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.
Changes in standard clinical outcome for tremor patients	5 years	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.

Trial Locations

Locations (1)

Massachusetts General Hospital, University of California San Francisco, University of Utah; 🇺🇸 Boston, Massachusetts, United States