Parkinson&Amp;#39;s DiseaseNCT07092995
Understanding Freezing of Gait Using Brain Signals and Virtual Reality
A study testing VR Freezing Task, Dual Task and External Cueing in people with Parkinson&Amp;#39;s Disease and Freezing of Gait, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Freezing of gait - the inability to start or continue walking - is a particularly disabling problem in Parkinson's disease that has few treatment options. This project records human brain activity from deep brain stimulation (DBS) devices during walking and freezing of gait episodes to understand the pathophysiology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson&Amp;#39;s Disease, Freezing of Gait, Freezing of Gait Symptoms in Parkinson&Amp;#39;s Disease
- What is being tested?
- VR Freezing Task, Dual Task and External Cueing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients meeting the MDS clinical diagnostic criteria for Parkinson's disease who are implanted with a Medtronic Percept DBS Device and SenSight Directional Leads in bilateral globus pallidus internus (GPi).
- Able to walk unassisted indoors
- Age 18 or older
- Half of patients will have disabling freezing of gait as defined by freezing more than once per day by self-report on questions 1 \& 2 of the New Freezing of Gait Questionnaire
- The other half of patients will not have freezing of gait as defined by self-report on question 1 of the New Freezing of Gait Questionnaire
Who cannot join
- Clinical diagnosis of dementia or severe cognitive impairment (MOCA < 21)
- History of stroke, traumatic brain injury, or other neurologic disorders besides Parkinson's disease
- Comorbidities causing severe gait impairments
- Unstable medical condition including cardio-vascular instability in the past 6 months
- Unable or unwilling to comply with the testing protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Leveraging Invasive Recordings and Immersive Virtual Reality to Characterize Freezing of Gait Mechanisms in Parkinson Disease
Freezing of gait - the inability to start or continue walking - is a particularly disabling problem in Parkinson's disease that has few treatment options. This project records human brain activity from deep brain stimulation (DBS) devices during walking and freezing of gait episodes to understand the pathophysiology of freezing of gait. Findings will lay the foundation for the development of new treatment strategies that address this disabling symptom.
Read the detailed description
The pathophysiology of FOG is poorly understood, likely contributing to disappointing results of novel neuromodulation strategies. The goal of this study is to identify electrophysiological mechanisms of FOG that can serve as biomarkers for novel neuromodulation strategies. Activity in the globus pallidus internus (GPi), the major output nucleus of the basal ganglia, is central to understanding basal ganglia contributions to gait impairment, as it provides insights into activity that downstream locomotor circuits read out from the basal ganglia. The project leverages a state-of-the-art multimodal brain/behavior recording platform and recent advances in sensing deep brain stimulation devices to record neural activity from the human GPi simultaneously with electroencephalography (EEG), motion capture and eye gaze during over-ground walking and FOG episodes in PD patients with and without FOG. To reliably elicit FOG episodes and improve external validity, the investigators implement a novel immersive virtual reality environment to recapitulate real-world scenarios that commonly trigger FOG. With these tools, the proposed studies will determine how gait-related neural oscillations in the beta (12-30 Hz) and theta/alpha (4-12 Hz) bands in the GPi and cortex relate to abnormal gait during continuous walking (Aim 1); the onset and recovery from FOG episodes (Aim 2); and the therapeutic benefits from external cues (Aim 3). This paves the way for multiple innovative neuromodulation strategies that (1) prevent FOG episodes by promoting normal or compensatory gait control during continuous walking and (2) ameliorate severity of FOG episodes by targeting signals associated with FOG onset and recovery. Additionally, it establishes a novel VR paradigm for future precision-medicine approaches to FOG therapeutic development.
- Conditions
- Parkinson&Amp;#39;s Disease, Freezing of Gait, Freezing of Gait Symptoms in Parkinson&Amp;#39;s Disease
- Being tested
- VR Freezing Task, Dual Task, External Cueing
- Keywords
- Deep brain stimulation, Freezing of gait, Walking, Globus pallidus internus (GPi), gait, virtual reality, electroencephalography (EEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Freezing TaskBehavioural
Walking overground in immersive virtual reality (VR) environments that provoke freezing episodes
Dual TaskBehavioural
Walking overground with and without concomitant performance of secondary cognitive or motor task
External CueingBehavioural
Walking overground in immersive virtual reality (VR) environments that provoke freezing episodes with and without addition of visual and auditory cues.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Neurophysiology and kinematics are measured during gait interventions Receives: Behavioral: VR Freezing Task; Behavioral: Dual Task; Behavioral: External Cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
GPi gait-related spectral power
Globus pallidus internus (GPi) spectral power change during walking versus standing rest.
Measured: Day 1
GPi event-related spectral power
Globus pallidus internus (GPi) spectral power changes from baseline time-locked to gait cycle events, freezing episodes, and voluntary stopping events
Measured: Day 2
GPi gait-related spectral power
Globus pallidus internus (GPi) spectral power change during walking with versus without external cues.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Nov 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson&Amp;#39;s DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn A. Cross, MD, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092995
- Sponsor's protocol ID
- 24-5770
- Other IDs
- 1R01NS140283
- Status last verified
- Nov 2025
- First submitted
- 16 Jul 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share only de-identified individual-participant level (IPD) data including demographics, raw electrophysiology, timestamps from annotated video, minimally pre-processed kinematic, and eye tracking data (interpolated markers and timeseries of fixation target).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Invasive Recordings and Immersive Virtual Reality to Characterize Freezing of Gait Mechanisms in Parkinson Disease
- ClinicalTrials.gov ID
- NCT07092995
- Acronym / sponsor ID
- 24-5770
- Conditions
- Parkinson&Amp;#39;s Disease, Freezing of Gait, Freezing of Gait Symptoms in Parkinson&Amp;#39;s Disease
- Keywords
- Deep brain stimulation, Freezing of gait, Walking, Globus pallidus internus (GPi), gait, virtual reality, electroencephalography (EEG)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Freezing of gait - the inability to start or continue walking - is a particularly disabling problem in Parkinson's disease that has few treatment options. This project records human brain activity from deep brain stimulation (DBS) devices during walking and freezing of gait episodes to understand the pathophysiology of freezing of gait. Findings will lay the foundation for the development of new treatment strategies that address this disabling symptom.
Detailed description
The pathophysiology of FOG is poorly understood, likely contributing to disappointing results of novel neuromodulation strategies. The goal of this study is to identify electrophysiological mechanisms of FOG that can serve as biomarkers for novel neuromodulation strategies. Activity in the globus pallidus internus (GPi), the major output nucleus of the basal ganglia, is central to understanding basal ganglia contributions to gait impairment, as it provides insights into activity that downstream locomotor circuits read out from the basal ganglia. The project leverages a state-of-the-art multimodal brain/behavior recording platform and recent advances in sensing deep brain stimulation devices to record neural activity from the human GPi simultaneously with electroencephalography (EEG), motion capture and eye gaze during over-ground walking and FOG episodes in PD patients with and without FOG. To reliably elicit FOG episodes and improve external validity, the investigators implement a novel immersive virtual reality environment to recapitulate real-world scenarios that commonly trigger FOG. With these tools, the proposed studies will determine how gait-related neural oscillations in the beta (12-30 Hz) and theta/alpha (4-12 Hz) bands in the GPi and cortex relate to abnormal gait during continuous walking (Aim 1); the onset and recovery from FOG episodes (Aim 2); and the therapeutic benefits from external cues (Aim 3). This paves the way for multiple innovative neuromodulation strategies that (1) prevent FOG episodes by promoting normal or compensatory gait control during continuous walking and (2) ameliorate severity of FOG episodes by targeting signals associated with FOG onset and recovery. Additionally, it establishes a novel VR paradigm for future precision-medicine approaches to FOG therapeutic development.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: VR Freezing Task, Behavioral: Dual Task, Behavioral: External CueingNeurophysiology and kinematics are measured during gait interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients meeting the MDS clinical diagnostic criteria for Parkinson's disease who are implanted with a Medtronic Percept DBS Device and SenSight Directional Leads in bilateral globus pallidus internus (GPi).
- Able to walk unassisted indoors
- Age 18 or older
- Half of patients will have disabling freezing of gait as defined by freezing more than once per day by self-report on questions 1 \& 2 of the New Freezing of Gait Questionnaire
- The other half of patients will not have freezing of gait as defined by self-report on question 1 of the New Freezing of Gait Questionnaire
Key exclusion criteria (5 listed)
- Clinical diagnosis of dementia or severe cognitive impairment (MOCA < 21)
- History of stroke, traumatic brain injury, or other neurologic disorders besides Parkinson's disease
- Comorbidities causing severe gait impairments
- Unstable medical condition including cardio-vascular instability in the past 6 months
- Unable or unwilling to comply with the testing protocol
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 |
|---|---|---|
| VR Freezing TaskWalking overground in immersive virtual reality (VR) environments that provoke freezing episodes | Behavioural | Experimental |
| Dual TaskWalking overground with and without concomitant performance of secondary cognitive or motor task | Behavioural | Experimental |
| External CueingWalking overground in immersive virtual reality (VR) environments that provoke freezing episodes with and without addition of visual and auditory cues. | Behavioural | Experimental |
Primary outcome
GPi gait-related spectral power
Time frame: Day 1
Globus pallidus internus (GPi) spectral power change during walking versus standing rest.
GPi event-related spectral power
Time frame: Day 2
Globus pallidus internus (GPi) spectral power changes from baseline time-locked to gait cycle events, freezing episodes, and voluntary stopping events
GPi gait-related spectral power
Time frame: Day 3
Globus pallidus internus (GPi) spectral power change during walking with versus without external cues.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. The investigators will share only de-identified individual-participant level (IPD) data including demographics, raw electrophysiology, timestamps from annotated video, minimally pre-processed kinematic, and eye tracking data (interpolated markers and timeseries of fixation target).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Freezing Task, Dual Task and External Cueing in people with Parkinson&Amp;#39;s Disease and Freezing of Gait, run by University of California, Los Angeles 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 5 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
GPi gait-related spectral power (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.