Understanding Freezing of Gait Using Brain Signals and Virtual Reality

February 13, 2026 updated by: Kathryn A. Cross, MD, PhD, University of California, Los Angeles

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Neurophysiology and kinematics are measured during gait interventions
Behavioral: VR Freezing Task
Walking overground in immersive virtual reality (VR) environments that provoke freezing episodes
Behavioral: Dual Task
Walking overground with and without concomitant performance of secondary cognitive or motor task
Behavioral: External Cueing
Walking overground in immersive virtual reality (VR) environments that provoke freezing episodes with and without addition of visual and auditory cues.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GPi gait-related spectral power
Time Frame: Day 1
Globus pallidus internus (GPi) spectral power change during walking versus standing rest.
Day 1
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
Day 2
GPi gait-related spectral power
Time Frame: Day 3
Globus pallidus internus (GPi) spectral power change during walking with versus without external cues.
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-5770
  • 1R01NS140283 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

At the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.

IPD Sharing Access Criteria

Data will be made available in the Data Archive for Brain Initiative (DABI) data repository (or equivalent), which restricts access to the data to qualified investigators with an appropriate research question and approved data use agreement (DUA) that limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in any unauthorized uses of the data. To get access to the data, the user must submit a valid scientific question, include a statistical analysis plan, and complete all required fields on the DABI data request form. When users request access to data stored in DABI, the owners of those data are the only ones who can grant or deny access (in this case the PI).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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