Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT05150093
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2021-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Sponsor:
Massachusetts Eye and Ear Infirmary
Organization:
Study Overview
Official Title:
Deep Brain Stimulation in Laryngeal Dystonia and Voice Tremor
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: