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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD Virtual Reality Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Environment | Other | Participants complete various tasks in a virtual home and grocery store environment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freezing of Gait | Number of freezing of gait episodes | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Velocity | Meters/second | Baseline |
| Turn Velocity | Degrees/second | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Alberts, Ph.D. | Staff | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42239677 | Derived | Alberts JL, Cantlay P, Rosenfeldt AB, Felix C, Waltz C, Bazyk AS, Berki V, Malan N, Nagel S, Walter B, Liao J, Escobar D, Baker KB, Miller Koop M. An initial machine learning model applied to local field potential data from the subthalamic nucleus to detect freezing of gait in Parkinson's disease. Front Neurol. 2026 May 19;17:1793291. doi: 10.3389/fneur.2026.1793291. eCollection 2026. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freezing of Gait | Number of freezing of gait episodes | Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed. | Posted | Mean | Standard Deviation | freezing of gait episodes | Baseline |
|
Through study completion, which was an average of 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Off DBS/Off Meds | Session completed with DBS stimulation turned off and participant OFF their PD meds for 12 hours prior. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Alberts, PhD | Cleveland Clinic | 216-445-3222 | albertj@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2023 | Oct 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Parkinson's Disease Duration | Mean | Standard Deviation | years |
|
| Years since DBS Placement | Mean | Standard Deviation | years |
|
| MDS-UPDRS III, OFF MEDS/OFF DBS | Global score of motor function in Parkinson's disease using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale subscale III (MDS-UPDRS III). Eighteen items scored on a 0-4 scale resulting in a combined score ranging from 0-72. A higher score (larger number) indicates more motor symptoms. | Mean | Standard Deviation | score on a scale |
|
|
|
| Secondary | Gait Velocity | Meters/second | Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed. | Posted | Mean | Standard Deviation | m/s | Baseline |
|
|
|
| Secondary | Turn Velocity | Degrees/second | Participants were assessed in the Off DBS/Off Meds condition and Off DBS/On Meds condition for outcome measures. No other conditions were assessed. | Posted | Mean | Standard Deviation | degrees/s | Baseline |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Off DBS/On Meds | Session completed with DBS stimulation turned off and participant ON their PD meds. | 0 | 15 | 0 | 15 | 1 | 15 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |