Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

NCT05103384 | Completed Results DMC

• 1 other identifier: 21-957
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Freezing of Gait

  Number of freezing of gait episodes

  Baseline

Secondary Outcomes (2)

• Gait Velocity

  Baseline

• Turn Velocity

  Baseline

Study Arms (1)

PD Virtual Reality Cohort

Other: Virtual Reality Environment

Interventions

Virtual Reality Environment OTHER

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

PD Virtual Reality Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease undergoing bilateral STN-DBS surgery at a Cleveland Clinic Facility or who have previously undergone STN-DBS surgery with the Medtronic Percept BrainSense DBS system.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Jay Alberts, PhD
• Organization: Cleveland Clinic

albertj@ccf.org

216-445-3222

Study Officials

• Jay Alberts, Ph.D.

  Staff

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Staff, Biomedical Engineering

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 2, 2021
• Study Start: July 22, 2022
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)