Deep brain stimulation effects on speech in Parkinson's disease
Role of Subthalamic Nucleus in Speech and Movement Among People With Parkinson's Disease as Revealed by Intraoperative Recordings and Deep Brain Stimulation
This study is trying to see how deep brain stimulation affects speech in people with Parkinson's disease by comparing their speech before and after surgery to those who don't have the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 84 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05493670 on ClinicalTrials.gov |
What this trial studies
This observational study aims to document speech performance in patients with Parkinson's disease who undergo deep brain stimulation (DBS) of the subthalamic nucleus (STN). It will compare speech outcomes before, during, and at 6 and 12 months after surgery in 80 patients with DBS to 40 non-surgical controls. The study will utilize intraoperative brain recordings to understand the role of STN in speech production and assess the impact of DBS on speech intelligibility and communication participation. Additionally, it will explore factors that predict communication ability post-surgery and test the feasibility of low-frequency DBS to improve speech outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with idiopathic Parkinson's disease who experience significant motor fluctuations and are responsive to dopaminergic medications.
Not a fit: Patients with significant hearing loss or those who rely on hearing aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved speech outcomes and communication abilities for patients with Parkinson's disease undergoing DBS.
How similar studies have performed: Other studies have shown varying success with deep brain stimulation approaches, but this specific focus on speech outcomes in Parkinson's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For inclusion in this study, participants must * have a confirmed diagnosis of idiopathic Parkinson's disease and no atypical Parkinsonism features * experience significant motor fluctuations * currently taking and responsive to dopaminergic medications (e.g. Levodopa) * use English as their primary language * lack significant cognitive impairment and be able to consent to participate Exclusion Criteria: * Significant hearing loss/reliance on hearing aids
Where this trial is running
Iowa City, Iowa
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Jeremy Greenlee, MD — University of Iowa Dept of Neurosurgery
- Study coordinator: Jeremy Greenlee, MD
- Email: jeremy-greenlee@uiowa.edu
- Phone: 319-356-2771
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.