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

NCT07026734 | Recruiting

• 2 other identifiers: IRB202300382R01DC020450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 These hypotheses were developed based on compelling published and unpublished preliminary data.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

Parkinson Disease, Idiopathic

Keywords

Parkinson disease; Deep brain stimulation; voice; speech; swallow

Outcome Measures

Primary Outcomes (3)

• Glottal closure

  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)

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

• Voluntary cough airflow

  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.

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

• Swallowing safety

  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.

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

Secondary Outcomes (9)

• Normalized glottal gap area

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

• Acoustic voice analysis

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

• Audio-perceptual analysis

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

• EGG

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

• Patient reported outcome - VHI

  Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit

Study Arms (2)

GPi DBS

OTHER

People with PD who are approved to receive deep brain stimulation (DBS) surgery to the globus pallidus internal segment.

Procedure: Deep brain stimulation surgery - GPi

STN DBS

OTHER

People with PD who are approved to receive deep brain stimulation (DBS) surgery to the subthalamic nucleus.

Procedure: Deep Brain Stimulation Surgery - STN

Interventions

Deep brain stimulation surgery - GPi PROCEDURE

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.

GPi DBS

Deep Brain Stimulation Surgery - STN PROCEDURE

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.

STN DBS

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Florida, Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Verbal Behavior; Communication; Behavior

Study Officials

• Karen Hegland, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuhan Mou, Ph.D.

CONTACT

352-273-6561; ymou@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The "intervention" is deep brain stimulation, and this is being done in the context of routine clinical care (i.e., the participants are not allocated to the GPi or STN by the study; this decision is made by the clinical team). The study investigates the pre/post DBS impact on laryngeal function and other laryngeal mediated behaviors, such as voice, swallow, and cough.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)