Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05103384
Other study ID # 21-957
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A