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NCT07026734 · ClinicalTrials.gov registry record · NA
The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease
A NA study of Parkinson Disease, Idiopathic, sponsored by University of Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT07026734: Recruiting NA study of Parkinson Disease, Idiopathic, sponsored by University of Florida.
NCT07026734 is a NA study of Parkinson Disease, Idiopathic that is actively recruiting participants, run by University of Florida. The registered enrollment target is 100 participants, above the 68-participant average among 3 other Parkinson Disease, Idiopathic trials with a reported enrollment target (47% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07026734, a NA study of Parkinson Disease, Idiopathic, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 whe
Primary Outcome
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)
Conditions Studied
Interventions
- PROCEDURE Deep brain stimulation surgery - GPi
- PROCEDURE Deep Brain Stimulation Surgery - STN
Study Locations (1)
Florida
- University of Florida, Norman Fixel Institute for Neurological Diseases - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-05-26 |
| Est. Completion | 2029-05 |
| Phase | NA |
What NCT07026734 shows while recruiting
NCT07026734 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 68-participant average among 3 other Parkinson Disease, Idiopathic trials with a reported enrollment target (47% higher).
The record links to 1 condition, with Parkinson Disease, Idiopathic appearing as the primary indexed condition, and to 2 interventions - of which Deep brain stimulation surgery - GPi is the first listed.
NCT07026734 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07026734 about?
NCT07026734 is a clinical study titled "The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease". 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...
What is the current status of trial NCT07026734?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-05-26. Estimated completion is 2029-05.
What conditions does trial NCT07026734 study?
This clinical trial studies the following conditions: Parkinson Disease, Idiopathic.
What interventions are being tested in trial NCT07026734?
The interventions under investigation include: Deep brain stimulation surgery - GPi (PROCEDURE), Deep Brain Stimulation Surgery - STN (PROCEDURE).
Who is sponsoring clinical trial NCT07026734?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07026734 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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