Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

Parkinson Disease Clinical Trial

Official title:

Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103384
• Other study ID #: 21-957
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: MacKenzie Dunlap
• Phone: 216-219-3949
• Email: dunlapm4[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Virtual Reality Environment
Participants complete various tasks in a virtual home and grocery store environment.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freezing of Gait	Number of freezing of gait episodes	Baseline
Secondary	Gait velocity	Meters/second	Baseline
Secondary	Turn velocity	Degrees/second	Baseline