CompletedNot Applicable

Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

United States15 participantsStarted 2022-07-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freezing of Gait

Timeframe: Baseline

Trial details

NCT IDNCT05103384

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-24

Results submitted2025-07-21

View on ClinicalTrials.gov More Parkinson Disease trials