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OpenTrials
Completed

NCT Number: NCT05103384

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Environment

Other

Participants complete various tasks in a virtual home and grocery store environment.

Primary outcomes

  1. Freezing of Gait

    Time frame: Baseline

    Number of freezing of gait episodes

Secondary outcomes

  1. Gait Velocity

    Time frame: Baseline

    Meters/second

  2. Turn Velocity

    Time frame: Baseline

    Degrees/second

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2021
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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