How deep brain stimulation affects speech and swallowing in Parkinson disease
Effects of Deep Brain Stimulation (DBS) on Laryngeal Function and Associated Behaviors in Parkinson Disease
This study will test whether deep brain stimulation to the subthalamic nucleus (STN) or globus pallidus interna (GPi) changes voice, speech, swallowing, and cough in people with idiopathic Parkinson disease who are approved for first-time DBS surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07026734 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll people with idiopathic Parkinson disease who are approved for first-time DBS to either STN or GPi and who have mild to moderate voice or swallowing problems. Participants will undergo validated, objective measurements of voice, speech, swallowing, and cough before and after surgery and with stimulation turned ON and OFF. The study will compare outcomes by target site (STN versus GPi) and incorporate neurostimulation parameters and connectivity information where available. The work is led by the University of Florida with collaboration from the NIDCD at a single center in Gainesville, Florida.
Who should consider this trial
Good fit: Adults with idiopathic (non‑genetic) Parkinson disease, Hoehn & Yahr stage I–IV, approved for first-time DBS to STN or GPi, and who have mild or moderate voice or swallowing problems are ideal candidates.
Not a fit: People with other neurologic disorders, prior DBS electrodes, severe cognitive or unstable psychiatric problems, structural or non‑PD voice disorders, chronic refractory cough, recent head/neck/lung cancer, or a bleeding disorder are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose DBS targets and counsel patients to reduce the risk of worsening voice or swallowing and improve quality of life.
How similar studies have performed: Prior reports are limited and inconclusive—most existing data come from bilateral STN DBS and do not definitively compare STN versus GPi effects on voice and swallowing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida
- University of Florida, Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Karen Hegland, Ph.D. — University of Florida
- Study coordinator: Yuhan Mou, Ph.D.
- Email: ymou@ufl.edu
- Phone: 352-273-6561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.