Recruiting

Deep Brain Stimulation

Sponsor:

VA Office of Research and Development

Code:

NCT06857851

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06857851

Start date

Feb 1, 2026

Status verified date

Jul, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Eye alignment - vergence gain [ Time Frame: One month ]
  • Strabismus [ Time Frame: One month ]

Central Contacts and Locations

Central contacts

Aasef G Shaikh, MD PhD

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

Cheryl Dudek

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

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Cheryl Dudek

216-679-3800cheryl.dudek@va.gov

Aasef G Shaikh, MD PhD

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

Principal Investigator:

Aasef G. Shaikh, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Parkinson's disease
  • Deep brain stimulation
  • subthalamic nucleus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-07.