Recruiting

DBS Comparison

Sponsor:

University of Florida

Code:

NCT07026734

Conditions

Parkinson Disease, Idiopathic

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation surgery - GPi

Deep Brain Stimulation Surgery - STN

Study Details

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 These hypotheses were developed based on compelling published and unpublished preliminary data.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

Study ID

NCT07026734

Start date

May 26, 2025

Status verified date

Jul, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: GPi DBS

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

other: STN DBS

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

Interventions

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.

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 measure

  • Glottal closure [ Time Frame: Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit ]
  • 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 ]
  • Swallowing safety [ Time Frame: Prior to DBS surgery, 4 - 12 months following DBS surgery, and 6 - 12 months after the last post-operative visit ]

Central Contacts and Locations

Central contacts

Locations

University of Florida, Norman Fixel Institute for Neurological Diseases

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Principal Investigator:

Karen Hegland, Ph.D.

More Information

Sponsor

University of Florida

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-21.