N/A N=15

Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

Parkinson Disease · DBS · Deep Brain Stimulation · Freezing of Gait · Virtual Reality

Bottom Line

View on ClinicalTrials.gov: NCT05103384 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Freezing of Gait — 2.6; 1.5 freezing of gait episodes

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Virtual Reality Environment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Freezing of Gait	2.6; 1.5	—
SECONDARY Gait Velocity	0.27; 0.29	—
SECONDARY Turn Velocity	21.7; 22.1	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05103384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.