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Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

Primary Purpose

Laryngeal Dystonia, Spasmodic Dysphonia, Tremor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Laryngeal Dystonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital, University of California San Francisco, University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrophysiological signal data collection

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2021
Last Updated
October 24, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Massachusetts General Hospital, University of Utah, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05150093
Brief Title
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Official Title
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Massachusetts General Hospital, University of Utah, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Dystonia, Spasmodic Dysphonia, Tremor, Dystonia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrophysiological signal data collection
Arm Type
Experimental
Arm Description
Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Clinically indicated DBS treatment for dystonia or tremor with simultaneous research electrocorticography (ECoG).
Primary Outcome Measure Information:
Title
Correlations between brain signals and intraoperative voice and speech production performance.
Description
Analysis of intraoperative recordings from deep basal ganglia structures and cortical regions relevant to voice and speech control.
Time Frame
5 years
Title
Changes in standard clinical outcome for dystonia patients
Description
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.
Time Frame
5 years
Title
Changes in standard clinical outcome for tremor patients
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Simonyan, MD, PhD
Phone
617-573-6016
Email
simonyan_lab@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Simonyan, MD, PhD
Organizational Affiliation
Massachusetts Eye and Ear
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital, University of California San Francisco, University of Utah
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Simonyan, MD, PhD
Phone
617-573-6016
Email
simonyan_lab@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Julie Barkmeier-Kraemer, PhD
First Name & Middle Initial & Last Name & Degree
Ian Bledsoe, MD, MS
First Name & Middle Initial & Last Name & Degree
Shervin Rahimpour, MD
First Name & Middle Initial & Last Name & Degree
Jeremy Greenlee, MD
First Name & Middle Initial & Last Name & Degree
Farid Hamzei-Sichani, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor

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