What this study is
Inability to align and refocus the eyes on the objects at different depths, i.e., vergence impairment and strabismus, frequently affects the quality of life in patients with Parkinson's disease. The investigators study aims to understand the location-specific effects of subthalamic region deep brain stimulation on vergence and strabismus by integrating the patient-specific deep brain stimulation models and high-resolution eye-tracking measures. The knowledge gained will allow the investigators to find the most beneficial stimulation location and parameters for improving binocular coordination, strabismus, and vergence while preserving the ability to treat motor symptoms in Parkinson's disease.
Study details
- Sponsor
- VA Office of Research and Development
- Conditions
- Parkinson's Disease
- Enrolling
- 80 people
- Starts
- 2026-02-01
- Est. completion
- 2029-10-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Parkinson's disease with bilateral STN DBS
- Availability of pre-operative MR images (with a T1-weighted, gradient-echo sequence) and ability to get post-operative MRI or CT scans
- Hoehn and Yahr stage 2-4 when off medication, and a stable antiparkinsonian medication regimen and DBS parameter settings
You can't join if
- Previous surgical therapy for Parkinson's disease (other than DBS)
- Dementia
- Clinically significant untreated depression or anxiety
- Clinical features suggestive of atypical parkinsonism
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLouis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
- Cheryl Dudek · Contact216-679-3800cheryl.dudek@va.gov
- Aasef G Shaikh, MD PhD · Contact(216) 791-3800 ext. 60000Aasef.Shaikh@va.gov
- Aasef G. Shaikh, MD PhD · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID C5298-R
Principal investigator
Aasef G. Shaikh, MD PhD
Louis Stokes VA Medical Center, Cleveland, OH
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.