NCT05400499 Deep Brain Stimulation for Visuomotor Function in Parkinson's Disease
| NCT ID | NCT05400499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Parkinson's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-10-04 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-10-04 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Inability to align and refocus the eyes on the objects at different depths, i.e., vergence impairment, frequently affects the quality of life in patients with Parkinson's disease. Our study aims to understand the location-specific effects of subthalamic region deep brain stimulation on vergence by integrating the patient-specific deep brain stimulation models and high-resolution eye-tracking measures. The knowledge gained will allow us to find the most beneficial stimulation location and parameters for improving binocular coordination and vergence while preserving the ability to treat motor symptoms in Parkinson's disease.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Previous surgical therapy for Parkinson's disease (other than DBS) * Dementia * Clinically significant untreated depression or anxiety * Clinical features suggestive of atypical parkinsonism
Contact & Investigator
Aasef G. Shaikh, MD PhD
PRINCIPAL INVESTIGATOR
Louis Stokes VA Medical Center, Cleveland, OH
Frequently Asked Questions
Who can join the NCT05400499 clinical trial?
This trial is open to participants of all sexes, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05400499 currently recruiting?
Yes, NCT05400499 is actively recruiting participants. Contact the research team at Aasef.Shaikh@va.gov for enrollment information.
Where is the NCT05400499 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05400499 clinical trial?
NCT05400499 is sponsored by VA Office of Research and Development. The principal investigator is Aasef G. Shaikh, MD PhD at Louis Stokes VA Medical Center, Cleveland, OH. The trial plans to enroll 40 participants.
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