Parkinson DiseaseNCT05103384
Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
An observational study of Parkinson Disease and DBS, run by The Cleveland Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, DBS, Deep Brain Stimulation
- What is being tested?
- Virtual Reality Environment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 24 Jun 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Virtual Reality Environment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality EnvironmentOther
Participants complete various tasks in a virtual home and grocery store environment.
| Study group | Role | What they receive |
|---|---|---|
| PD Virtual Reality Cohort | Not described Receives: Other: Virtual Reality Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of Gait
Number of freezing of gait episodes
Measured: Baseline
Secondary outcomes (2)
Gait Velocity
Meters/second
Measured: Baseline
Turn Velocity
Degrees/second
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start22 Jul 2022
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Jay Alberts, The Cleveland Clinic
- Investigators
- Jay Alberts, Ph.D., Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103384
- Sponsor's protocol ID
- 21-957
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2021
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42239677
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming
- ClinicalTrials.gov ID
- NCT05103384
- Acronym / sponsor ID
- 21-957
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Virtual Reality Cohort | – | Other: Virtual Reality Environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality EnvironmentParticipants complete various tasks in a virtual home and grocery store environment. | Other | PD Virtual Reality Cohort |
Primary outcome
Freezing of Gait
Time frame: Baseline
Number of freezing of gait episodes
2 secondary outcomes
Gait Velocity
Time frame: Baseline
Turn Velocity
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42239677Alberts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Alberts, Ph.D. principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and DBS, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing of Gait (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.