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

RecruitingNAAges 45 Years - 85 YearsAllUniversity of Florida
NCT07026734 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 thes

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📋 Eligibility rules (as published)
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
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What it tests

  • Deep brain stimulation surgery - GPi
  • Deep Brain Stimulation Surgery - STN
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Where

1 site
University of Florida, Norman Fixel Institute for Neurological Diseases
Gainesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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