Actively Recruiting
Effects of Deep Brain Stimulation on Voice, Swallowing, and Cough Function in Parkinson Disease
Led by University of Florida · Updated on 2025-07-24
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Parkinson disease (PD) is a common neurodegenerative disorder affecting many adults, with numbers expected to rise significantly by 2030. This trial investigates the impact of deep brain stimulation (DBS) on laryngeal functions—voice, swallowing, and cough—in people with PD. Specifically, it compares DBS targeting the subthalamic nucleus (STN) and globus pallidus interna (GPi) to understand how these treatments affect communication and airway protection, which are important for patients' quality of life and health outcomes. Participants approved for DBS surgery will be divided into two groups based on their DBS target: STN or GPi. Each group will have four study visits spaced 6 to 12 months apart, including before surgery, after unilateral and bilateral lead placement with activation and programming, and a follow-up visit 6 to 12 months after the last. Assessments will be done with stimulators on and off to evaluate how stimulation affects laryngeal motor control. DBS surgery will be performed as part of routine clinical care, with no randomization to treatment groups. Participants will undergo various evaluations at each visit, including motor function tests, pulmonary function tests, cognitive assessment, laryngeal imaging, acoustic and audio-perceptual voice analysis, voluntary and induced cough measurements, and swallowing evaluation using videofluoroscopy. These assessments will measure glottal closure, cough airflow, swallowing safety, and related functions both before and after DBS surgery to track changes. The study aims to provide guidance on whether voice, swallow, or cough functions should influence DBS target selection and treatment planning for people with PD.
CONDITIONS
Brief Title
The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic Parkinson disease confirmed by a specialist using strict criteria
- Hoehn & Yahr stage I to IV
- Approved for DBS surgery targeting either the subthalamic nucleus (STN) or globus pallidus interna (GPi) with no existing DBS electrodes
- Mild or moderate voice or swallowing problems
You will not qualify if you...
- Neurological disorders other than Parkinson disease, including essential tremor
- Severe neuropsychological dysfunction or unstable psychiatric conditions such as severe depression
- Moderate to severe cognitive impairment
- History of head, neck, or lung cancer (except minor skin cancers)
- Structural, functional, or neurologic voice disorders unrelated to Parkinson disease
- Chronic refractory cough
- Bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 12 months
Participants undergo deep brain stimulation (DBS) surgery targeting either the subthalamic nucleus (STN) or globus pallidus interna (GPi) as part of their clinical care. The treatment includes initial unilateral DBS lead placement followed by a second lead placement for bilateral stimulation.
3 visits spaced approximately 6 to 12 months apart
Duration - 6 to 12 months
Participants complete follow-up assessments 6 to 12 months after bilateral DBS lead placement to evaluate voice, swallowing, and cough functions under stimulator on and off conditions.
1 follow-up visit over 2 days (in-person, with stimulator on and off assessments)
Trial Site Locations
Total: 1 location
1
University of Florida, Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States, 32611
Actively Recruiting
Research Team
Y
Yuhan Mou, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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