Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

Completed

• Conditions: Virtual Reality; DBS; Parkinson Disease; Deep Brain Stimulation; Freezing of Gait
• Interventions: Other: Virtual Reality Environment

• Registration Number: NCT05103384
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-11-02
• Study Start: 2022-07-22
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD Virtual Reality Cohort	Virtual Reality Environment	-

Primary Outcome Measures

Name	Time	Method
Freezing of Gait	Baseline	Number of freezing of gait episodes

Secondary Outcome Measures

Name	Time	Method
Turn velocity	Baseline	Degrees/second
Gait velocity	Baseline	Meters/second

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States