Parkinson Disease Clinical Trial
Official title:
Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
NCT number | NCT05103384 |
Other study ID # | 21-957 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 22, 2022 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | Michael J. Fox Foundation for Parkinson's Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freezing of Gait | Number of freezing of gait episodes | Baseline | |
Secondary | Gait velocity | Meters/second | Baseline | |
Secondary | Turn velocity | Degrees/second | Baseline |
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