Understanding Freezing of Gait Using Brain Signals and Virtual Reality

NCT07092995 | Enrolling By Invitation

• 2 other identifiers: 24-57701R01NS140283
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 of freezing of gait. Findings will lay the foundation for the development of new treatment strategies that address this disabling symptom.

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)

Outcome Measures

Primary Outcomes (3)

• GPi gait-related spectral power

  Globus pallidus internus (GPi) spectral power change during walking versus standing rest.

  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

  Day 2

• GPi gait-related spectral power

  Globus pallidus internus (GPi) spectral power change during walking with versus without external cues.

  Day 3

Study Arms (1)

Experimental

EXPERIMENTAL

Neurophysiology and kinematics are measured during gait interventions

Behavioral: VR Freezing Task; Behavioral: Dual Task; Behavioral: External Cueing

Interventions

VR Freezing Task BEHAVIORAL

Walking overground in immersive virtual reality (VR) environments that provoke freezing episodes

Experimental

Dual Task BEHAVIORAL

Walking overground with and without concomitant performance of secondary cognitive or motor task

Experimental

External Cueing BEHAVIORAL

Walking overground in immersive virtual reality (VR) environments that provoke freezing episodes with and without addition of visual and auditory cues.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 30, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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).

Locations

US (1)