Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Individuals who underwent deep brain stimulator (DBS) surgery for PD will complete the V-GAIT modules. V-GAIT modules combine a virtual reality (VR) headset and a omnidirectional treadmill that allows the user to start, stop, and turn. Wires from the DBS will be externalized, or come out through the skin. The externalized wires will be used to read neural data from the DBS lead. This allows the researchers to examine the neural signal in the subthalamic nucleus (STN). If the participant has a Medtronic Percept DBS system, the wires will not be externalized. During episodes of freezing of gait, the neural recording will be used to identify specific neural signatures. This project will allow medical professionals and researchers to understand the mechanism behind freezing of gait and eventually improve care.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PD Virtual Reality Cohort
|
Other: Virtual Reality Environment
Participants complete various tasks in a virtual home and grocery store environment.
|
Outcome Measures
Primary Outcome Measures
- Freezing of Gait [Baseline]
Number of freezing of gait episodes
Secondary Outcome Measures
- Gait velocity [Baseline]
Meters/second
- Turn velocity [Baseline]
Degrees/second
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of idiopathic PD
-
Undergoing scheduled surgery for bilateral STN-DBS at a Cleveland Clinic facility or previously undergone, at least six months prior to enrollment, 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
- Michael J. Fox Foundation for Parkinson's Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-957