Deep Brain Stimulation and Speech/Swallow Function in Parkinson's Disease
This study is looking at how Deep Brain Stimulation (DBS) surgery, a treatment for Parkinson's disease (PD), affects your speech and ability to swallow. Researchers want to understand if DBS targeting the GPi or STN parts of the brain has different effects on these functions. You might be able to join if you have idiopathic (non-genetic) Parkinson's disease, are between 45 and 85 years old, have mild to moderate voice or swallowing problems, and are approved for DBS surgery but haven't had it yet. The study will measure changes in your voice, cough, and swallowing safety before and after your DBS surgery. The current status of this study is unclear, and it plans to enroll 100 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment (DBS surgery) as part of their normal care. It plans to enroll 100 participants.
- What's involved
- You would have your voice, cough, and swallowing safety measured before your DBS surgery, and then again 4-12 months after surgery, and 6-12 months after your last post-operative visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 6-12 months after your last post-operative visit following DBS surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease
At a glance
Conditions
NCT07026734
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Florida, Norman Fixel Institute for Neurological Diseases
Gainesville, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Karen Hegland, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
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Exclusion
What this trial measures
- Glottal closurePrior 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 airflowPrior 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 safetyPrior 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.