Optimizing Deep Brain Stimulation to Improve Visuomotor Function in Parkinson's Disease

NCT06857851 | Not Yet Recruiting DMC

• 2 other identifiers: C5298-RI01RX005298-01A1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Deep brain stimulation; subthalamic nucleus

Outcome Measures

Primary Outcomes (2)

• Eye alignment - vergence gain

  The investigators will measure vergence gain as one outcome measure. This measure will be calculated by measuring ratio of observed versus expected difference between the horizontal angular positions of the right and left eye as participants move gaze from far to near or vice versa.

  One month

• Strabismus

  The investigators will measure difference in position of right versus left eye as participants hold gaze on object of interest.

  One month

Study Arms (1)

Parkinson's disease with DBS

This is the only group. The patients in this group will have bilateral subthalamic region deep brain stimulator. They will be recruited after they are therapeutically optimized on stimulation as well as medical therapy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

United States Military Veterans

You 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 may not qualify if:

• Previous surgical therapy for Parkinson's disease (other than DBS)
• Dementia
• Clinically significant untreated depression or anxiety
• Clinical features suggestive of atypical parkinsonism

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Aasef G. Shaikh, MD PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aasef G Shaikh, MD PhD

CONTACT

(216) 791-3800; Aasef.Shaikh@va.gov

Cheryl Dudek

CONTACT

(216) 679-3800; cheryl.dudek@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 4, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)