NCT07026734 · University of Florida
The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease
What this study 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.
View original scientific description
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 These hypotheses were developed based on compelling published and unpublished preliminary data.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.
Interventions
PROCEDURE
Deep brain stimulation surgery - GPi
Deep brain stimulation (DBS) surgery will be performed as normal clinical care. People with PD who are approved for GPi DBS will be enrolled in the study prior to their surgery.
PROCEDURE
Deep Brain Stimulation Surgery - STN
Deep brain stimulation (DBS) surgery will be performed as normal clinical care. People with PD who are approved for STN DBS will be enrolled in the study prior to their surgery.
Primary outcome measures
Glottal closure
Time frame: Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit
Flexible or rigid endoscopy will be used to image the larynx. From these images, glottal closure will be analyzed using a 6-point scale ranging from 1 (complete glottal closure along all length of the vocal folds) and 6 (Incomplete glottal closure along all length of the vocal folds)
Voluntary cough airflow
Time frame: Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit
The airflow signal from the voluntary cough task will be measured to determine peak airflow, total volume of airflow, and rise time to peak flow.
Swallowing safety
Time frame: Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit
The penetration-aspiration scale will be used to determine whether swallowed material enters the airway, and how far down it goes (i.e., above, at, or below the level of the vocal folds) and whether there is visible residue.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of idiopathic (non-genetic/familial) PD made by fellowship-trained neurologist by applying strict UK brain bank criteria Hoehn \& Yahr staging I - IV Approved for DBS surgery to either STN or GPi, with NO existing DBS electrodes. Mild or moderate voice / swallow problems
Exclusion criteria
- Neurological disorder(s) other than PD (including essential tremor) Severe neuropsychological dysfunction, unstable psychiatric disease at the discretion of the treating neurologist/psychiatrist (i.e., severe depression) or moderate to severe cognitive impairment. History of:
- Head, neck, or lung cancer (except minor squamous cell skin cancers)
- Structural, functional, or neurologic voice disorder unrelated to PD
- Chronic refractory cough
- Bleeding disorder
Where
- Gainesville, Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations