Clinical trial NCT05103384: Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
Official title: Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
DBS
Deep Brain Stimulation
Freezing of Gait
Virtual Reality
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2021-11-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

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

Primary outcomes:
measure: Freezing of Gait
timeFrame: Baseline
Secondary outcomes:
measure: Gait velocity
timeFrame: Baseline
measure: Turn velocity
timeFrame: Baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: