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Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

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ClinicalTrials.gov Identifier: NCT05150093
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Utah
University of California, San Francisco
Information provided by (Responsible Party):
Kristina Simonyan, Massachusetts Eye and Ear Infirmary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Laryngeal Dystonia Spasmodic Dysphonia Tremor Dystonia Procedure: Deep Brain Stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: Deep Brain Stimulation
Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05150093


Contacts
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Contact: Husam Hammad, MS, MPH 617-573-6016 simonyan_lab@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital, University of California San Francisco, University of Utah Recruiting
Boston, Massachusetts, United States, 02114
Contact: Husam Hammad, MS, MPH    617-573-6016    simonyan_lab@meei.harvard.edu   
Principal Investigator: Robert M Richardson, MD, PhD         
Principal Investigator: Doris Wang, MD, PhD         
Principal Investigator: John Rolston, MD, PhD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Massachusetts General Hospital
University of Utah
University of California, San Francisco
Investigators
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Study Director: Kristina Simonyan, MD, PhD Massachusetts Eye and Ear
More Information
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Responsible Party: Kristina Simonyan, Associate Professor of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT05150093    
Other Study ID Numbers: 2021P003236
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysphonia
Dystonia
Dystonic Disorders
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Movement Disorders
Central Nervous System Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases