NCT05103384

Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Parkinson Disease
• DBS
• Deep Brain Stimulation
• Freezing of Gait
• Virtual Reality

Interventions

Type	Name	Description
OTHER	Virtual Reality Environment	Participants complete various tasks in a virtual home and grocery store environment.

Timeline

• Start date: 2022-07-22
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2021-11-02
• Last updated: 2025-11-04
• Results posted: 2025-11-04

Locations

1 site across 1 country: United States