Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

NCT05150093 | Recruiting

• 1 other identifier: 2021P003236
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Dystonia; Spasmodic Dysphonia; Tremor; Dystonia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Electrophysiological signal data collection

EXPERIMENTAL

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

Procedure: Deep Brain Stimulation

Interventions

Deep Brain Stimulation PROCEDURE

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

Electrophysiological signal data collection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The ability to comply with test directions, complete pre-operative task training, and provide informed consent.
• Age 18-80 years.

You may not qualify if:

• \. Inability to understand or perform the task outlined in the protocol during a pre-surgery training session. 2. Significant hearing loss.
• \. Cortical venous anatomy that could potentially obstruct ECoG electrode placement, as determined by the surgeon, visualized on pre-op MRI or during surgery.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Massachusetts General Hospital: collaborator
• University of Utah: collaborator
• University of California, San Francisco: collaborator
• UMass Memorial Health: collaborator
• University of Iowa: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia; Tremor; Dystonia

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; Dyskinesias

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Kristina Simonyan, MD, PhD

  Massachusetts Eye and Ear

  STUDY DIRECTOR

Central Study Contacts

Kristina Simonyan, MD, PhD

CONTACT

617-573-6016; simonyan_lab@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 8, 2021
• Study Start: June 21, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)