Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

The project uses virtual reality technology to recreate situations that cause freezing of gait in individuals with Parkinson's disease. Individuals who underwent deep brain stimulator (DBS) surgery for Parkinson's disease will walk through a virtual reality environment while brain signals are recorded from the DBS device. The goal is to better understand what occurs in the brain during freezing of gait.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Virtual Reality; Freezing of Gait; Deep Brain Stimulation; DBS
• Intervention / Treatment: Other: Virtual Reality Environment

Detailed Description

Falls related to problems with posture and walking as well as freezing of gait (FOG) occur in nearly 80% of people with Parkinson's disease (PD). Despite falls occurring in the daily lives of people with PD, it is difficult to produce FOG episodes in a doctor's office or other clinical setting. We will therefore use virtual reality to create an environment that can consistently produce FOG episodes in people with PD. By purposely producing FOG while people are wearing equipment that monitors brain activity, we can see where in the brain FOG is triggered. Study participants will be asked to wear a virtual reality (VR) headset and heart rate monitor and walk on a treadmill that permits users to start, stop, and turn, allowing them to naturally walk through a virtual environment. We will record the activity from the DBS system while participants perform the tasks. Participants will also complete clinical assessments of PD, a FOG questionnaire and cognitive tests that include naming objects and recalling items from a list.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease undergoing bilateral STN-DBS surgery at a Cleveland Clinic Facility or who have previously undergone STN-DBS surgery with the Medtronic Percept BrainSense DBS system.

Description

Inclusion Criteria:

• Clinical diagnosis of idiopathic PD
• Undergoing scheduled surgery for bilateral STN-DBS at a Cleveland Clinic facility or previously undergone STN-DBS surgery with the Medtronic Percept BrainSense DBS system
• Self-reported response of one or greater on question #3 of the Freezing of Gait Questionnaire (FOG-Q)
• Ability to walk independently for a minimum of 10 minutes
• Ability to provide informed consent

Exclusion Criteria:

• Neurological disease other than PD, such as stroke or multiple sclerosis
• Musculoskeletal impairment that affects one's ability to ambulate
• Presence of active and untreated psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder. Depression and anxiety are very common in patients with Parkinson's disease and are often mitigated as part of routine care. Depression and anxiety will not preclude study participation
• Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation
• Current alcohol or substance abuse
• Hearing or visual impairment precluding VR use
• Lack of fluency in English which may invalidate certain tests

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PD Virtual Reality Cohort	Other: Virtual Reality Environment; Participants complete various tasks in a virtual home and grocery store environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freezing of Gait	Number of freezing of gait episodes	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Velocity	Meters/second	Baseline
Turn Velocity	Degrees/second	Baseline

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Michael J. Fox Foundation for Parkinson's Research
• Investigators: Principal Investigator: Jay Alberts, Ph.D., staff

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 21-957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No