Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease

NCT07748962 | Not Yet Recruiting

• 1 other identifier: 26-526
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Deep brain stimulation; Balance; Postural instability; Gait dysfunction; Virtual reality; Mixed reality; Percept; Falls; Parkinson's disease; DBS

Outcome Measures

Primary Outcomes (1)

• Change in STN-LFP power fluctuations from single-task walking compared to FOG episode

  Participants will complete motor, cognitive and dual-task modules in a virtual reality environment that simulates a home-setting, allowing for acquisition of real-world, at-home behavior. They will also complete a stair navigation task under both single and dual-task conditions. During these assessments, neural activity (i.e., subthalamic nucleus local field potentials (STN-LFPs)) will be recorded from the Medtronic Percept Deep Brain Stimulation system. Freezing of gait (FOG) episodes will be marked by a clinician, and change in STN-LFP power fluctuations from single-task walking compared to FOG episodes will be analyzed as the primary outcome.

  Five sessions completed from enrollment to the end of testing, over an average of one week.

Secondary Outcomes (2)

• Number of FOG episodes during the MOVE system modules under each of the four DBS conditions

  Five sessions completed from enrollment to the end of testing, over an average of one week.

• Overall time for SAFE-Gait task

  Five sessions completed from enrollment to the end of testing, over an average of one week.

Study Arms (1)

Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments

EXPERIMENTAL

All participants undergo repeated assessments under multiple deep brain stimulation (DBS) conditions in a randomized order. Each participant serves as their own control and completes testing under clinically optimized stimulation, as well as alternative stimulation paradigms. An additional baseline condition without stimulation is performed prior to randomized testing. Assessments include walking and balance tasks performed in a virtual reality environment designed to simulate real-world gait challenges, as well as stair ambulation and functional mobility tasks. Neural activity is recorded from the implanted DBS device and synchronized with biomechanical and kinematic data collected during task performance. This design enables within-subject comparisons of neural activity and gait performance across stimulation conditions.

Other: Multiple Deep Brain Stimulation (DBS) Conditions; Behavioral: Moving Overground in a Virtual Environment (MOVE); Behavioral: Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)

Interventions

Multiple Deep Brain Stimulation (DBS) Conditions OTHER

Participants have the Medtronic Percept DBS system implanted as part of standard clinical care. During study sessions, stimulation is evaluated under different conditions, including clinically optimized stimulation, off stimulation, and alternative stimulation paradigms. Stimulation settings are temporarily adjusted for research assessments and are returned to clinically optimized settings at the end of each session. Effects of those conditions on task performance are being assessed.

Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments

Moving Overground in a Virtual Environment (MOVE) BEHAVIORAL

Participants complete walking and balance tasks within a virtual reality environment designed to simulate real-world situations that provoke gait disturbances. Tasks include navigating environmental constraints, performing turning and stopping movements, and completing dual-task cognitive challenges while walking.

Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments

Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait) BEHAVIORAL

Participants complete stair ambulation and functional mobility tasks on an instrumented platform, including ascending and descending steps, walking, turning, and performing dual-task conditions. These assessments provide quantitative measures of gait performance, balance, and functional mobility.

Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments

Eligibility Criteria

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

You may qualify if:

• You have been diagnosed with Parkinson's disease
• You already have a deep brain stimulation (DBS) device implanted as part of your medical care - specifically, the Medtronic Percept DBS device
• Your DBS settings have been stable for at least 3 months
• You experience freezing of gait (sudden inability to move your feet when trying to walk)
• You are able to walk on your own for at least 10 minutes without assistance
• You are willing to temporarily stop your Parkinson's medications and have your DBS settings adjusted for study testing
• You are able to understand the study and provide consent to participate

You may not qualify if:

• You have a neurological condition other than Parkinson's disease (such as stroke or multiple sclerosis)
• You have been diagnosed with dementia or have difficulty understanding the study or giving consent
• You currently have alcohol or substance abuse problems
• You have hearing or vision problems that would make it difficult to use a virtual reality headset
• You have any medical or mental health condition that, in the opinion of the study doctor, would make it unsafe or difficult for you to participate

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Medtronic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jay L Alberts, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MacKenzie Dunlap

CONTACT

216-219-3949; dunlapm4@ccf.org

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: Staff

Model Details: All participants will complete all assessments and DBS conditions. They will first complete an ON medication/ON DBS session, followed by an OFF medication/OFF DBS session. The remaining 3 DBS testing conditions will be completed in a randomized order for each participant.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 18, 2026
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): April 18, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)