DBS, Deep Brain Stimulation, Freezing of Gait, Parkinson Disease, Virtual Reality
Conditions
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.
Interventions
OTHERVirtual Reality Environment
Participants complete various tasks in a virtual home and grocery store environment.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freezing of Gait | Baseline | Number of freezing of gait episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | Baseline | Meters/second |
| Turn Velocity | Baseline | Degrees/second |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PD Virtual Reality Cohort Participants with Parkinson's disease complete cognitive and motor tasks while wearing a virtual reality headset and walking on an omnidirectional treadmill. The virtual reality headset immerses the participant in a virtual home environment designed to elicit freezing of gait episodes. While completing tasks in the virtual home environment, researchers monitor for freezing of gait episodes to investigate neural signatures associated with freezing. Each participant completed the virtual reality modules under two conditions: OFF DBS/OFF PD Meds and OFF DBS/ON PD Meds. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Too severely affected Off Meds/Off DBS to complete entire protocol | 4 |
Baseline characteristics
| Characteristic | PD Virtual Reality Cohort |
|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| MDS-UPDRS III, OFF MEDS/OFF DBS | 59.2 score on a scale STANDARD_DEVIATION 19.7 |
| Parkinson's Disease Duration | 10.1 years STANDARD_DEVIATION 5.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
| Years since DBS Placement | 2.5 years STANDARD_DEVIATION 3.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Freezing of Gait
Number of freezing of gait episodes
Time frame: Baseline
Population: Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OFF DBS/OFF PD Meds | Freezing of Gait | 2.6 freezing of gait episodes | Standard Deviation 2.6 |
| OFF DBS/ON PD Meds | Freezing of Gait | 1.5 freezing of gait episodes | Standard Deviation 2.1 |
Secondary
Gait Velocity
Meters/second
Time frame: Baseline
Population: Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OFF DBS/OFF PD Meds | Gait Velocity | 0.27 m/s | Standard Deviation 0.06 |
| OFF DBS/ON PD Meds | Gait Velocity | 0.29 m/s | Standard Deviation 0.07 |
Secondary
Turn Velocity
Degrees/second
Time frame: Baseline
Population: Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OFF DBS/OFF PD Meds | Turn Velocity | 21.7 degrees/s | Standard Deviation 6 |
| OFF DBS/ON PD Meds | Turn Velocity | 22.1 degrees/s | Standard Deviation 5.9 |