Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

NeuroTherapia, Inc.

Status

Completed

Conditions

Freezing of Gait

Parkinson Disease

Deep Brain Stimulation

DBS

Virtual Reality

Treatments

Other: Virtual Reality Environment

Study type

Observational

Funder types

Other

Identifiers

NCT05103384

21-957

Details and patient eligibility

About

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.

Full description

Falls related to problems with posture and walking as well as freezing of gait (FOG) occur in nearly 80% of people with Parkinson's disease (PD). Despite falls occurring in the daily lives of people with PD, it is difficult to produce FOG episodes in a doctor's office or other clinical setting. We will therefore use virtual reality to create an environment that can consistently produce FOG episodes in people with PD. By purposely producing FOG while people are wearing equipment that monitors brain activity, we can see where in the brain FOG is triggered. Study participants will be asked to wear a virtual reality (VR) headset and heart rate monitor and walk on a treadmill that permits users to start, stop, and turn, allowing them to naturally walk through a virtual environment. We will record the activity from the DBS system while participants perform the tasks. Participants will also complete clinical assessments of PD, a FOG questionnaire and cognitive tests that include naming objects and recalling items from a list.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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