Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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).

Recruiting Locations

Massachusetts General Hospital, University of California San Francisco, University of Utah
Boston, Massachusetts 02114
Contact:
Kristina Simonyan, MD, PhD
617-573-6016
simonyan_lab@meei.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts Eye and Ear Infirmary

Study Contact

Kristina Simonyan, MD, PhD
617-573-6016
simonyan_lab@meei.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.