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NCT Number: NCT05150093

Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Farid Hamzei-Sichani, MD, PhD

PRINCIPAL_INVESTIGATOR

Ian Bledsoe, MD, MS

PRINCIPAL_INVESTIGATOR

Jeremy Greenlee, MD

PRINCIPAL_INVESTIGATOR

Julie Barkmeier-Kraemer, PhD

PRINCIPAL_INVESTIGATOR

Kristina Simonyan, MD, PhD

CONTACT

[email protected]

617-573-6016

Shervin Rahimpour, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • 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.

Exclusion

  • 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.

Treatment and study plan

Deep Brain Stimulation

Procedure

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

Primary outcomes

  1. Correlations between brain signals and intraoperative voice and speech production performance.

    Time frame: 5 years

    Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.

  2. Changes in standard clinical outcome for dystonia patients

    Time frame: 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.

  3. Changes in standard clinical outcome for tremor patients

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Simonyan, MD, PhD

CONTACT

[email protected]

617-573-6016

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • Massachusetts General Hospital
  • UMass Memorial Health
  • University of California, San Francisco
  • University of Iowa
  • University of Utah

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2021
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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