Actively Recruiting

Phase Not Applicable
Age: 45Years - 85Years
All Genders
NCT07026734

The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease

Led by University of Florida · Updated on 2025-07-24

100

Participants Needed

1

Research Sites

205 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

Nearly one-million people in North America are now living with Parkinson's disease (PD), and that number is projected to rise to nearly 1.2 million by 2030. With advancements in neuromodulatory technologies, increasingly more of these individuals elect to undergo deep brain stimulation (DBS) surgery in order to control symptoms of the disease, including refractory tremor, medication-induced dyskinesias, and PD-associated dystonia. The two most common DBS neural targets for controlling these symptoms are the globus pallidus internal segment (GPi) and the subthalamic nucleus (STN). Recent meta-analyses have shown relative equivalence between these two sites at controlling core PD symptoms. To date, there is not conclusive evidence regarding the potential impact of DBS to GPi or STN on laryngeal-mediated functions of voice, swallowing, and cough, and consequently no guidance on whether these outcomes should be considered when selecting DBS target. Therefore, the goal of this project is to determine the impact of DBS neural target (STN versus GPi), lead location within the target, laterality, and stimulation settings on voice, swallow and cough function in people with PD. The larynx is an important player in each of these functions, and our central hypothesis is that spread of stimulation to corticobulbar fibers in the genu of the internal capsule have deleterious effects on laryngeal motor control, resulting in voice, swallow, and cough dysfunction. We have identified three specific aims for this application: 1.) To compare laryngeal function during volitional voice tasks pre-post DBS, and when DBS placement is bilateral versus unilateral for STN and GPi targets. 2.) To compare laryngeal function during volitional and induced cough tasks pre-post DBS, and when DBS placement is bilateral versus unilateral for STN and GPi targets. 3.) To compare airway safety associated with laryngeal onset, degree, and duration of maximum closure during swallowing, pre-post DBS, and when DBS placement is bilateral versus unilateral for STN and GPi targets. These hypotheses were developed based on compelling published and unpublished preliminary data. We will accomplish these aims by enrolling people with PD who are being considered for DBS surgery. We will measure physiologic, functional, and quality of life parameters of voice, swallow and cough pre- and post-surgically. The realization of the proposed aims is significant because it will address a substantial gap in our understanding of DBS outcomes related to communication and airway protection, which are important in terms of morbidity, mortality, and quality of life for patients with PD. The translational potential to provide additional guidance to DBS surgical teams regarding whether voice, swallow or cough functions should be considered with selecting DBS target and/or laterality is high. Ultimately, the project fits squarely within the overarching goal of the research team to deliver the best possible care to people with PD.

CONDITIONS

Official Title

The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease

Who Can Participate

Age: 45Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic (non-genetic/familial) Parkinson's disease by a fellowship-trained neurologist using strict UK brain bank criteria
  • Hoehn & Yahr stage I to IV
  • Approved for deep brain stimulation surgery to either the subthalamic nucleus (STN) or globus pallidus interna (GPi) with no existing DBS electrodes
  • Mild or moderate voice or swallowing problems
Not Eligible

You will not qualify if you...

  • Neurological disorders other than Parkinson's disease, including essential tremor
  • Severe neuropsychological dysfunction or unstable psychiatric disease as judged by treating neurologist or psychiatrist
  • Moderate to severe cognitive impairment
  • History of head, neck, or lung cancer (except minor squamous cell skin cancers)
  • Structural, functional, or neurologic voice disorders unrelated to Parkinson's disease
  • Chronic refractory cough
  • Bleeding disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Florida, Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States, 32611

Actively Recruiting

Loading map...

Research Team

Y

Yuhan Mou, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here