Recruiting

DBS

Sponsor:

The Cleveland Clinic

Code:

NCT07748962

Conditions

Parkinson Disease

Freezing of Gait

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multiple Deep Brain Stimulation (DBS) Conditions

Moving Overground in a Virtual Environment (MOVE)

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

Study Details

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

Study ID

NCT07748962

Start date

Dec 9, 2026

Status verified date

Oct, 2026

Completion date

Apr 18, 2027

Anticipated

Primary completion date

Mar 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments

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.

Interventions

Multiple Deep Brain Stimulation (DBS) Conditions

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.

Moving Overground in a Virtual Environment (MOVE)

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.

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

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.

Primary outcome measure

  • Change in STN-LFP power fluctuations from single-task walking compared to FOG episode [ Time Frame: Five sessions completed from enrollment to the end of testing, over an average of one week. ]

Central Contacts and Locations

Central contacts

MacKenzie Dunlap

216-219-3949dunlapm4@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

MacKenzie Dunlap

216-219-3949dunlapm4@ccf.org

Principal Investigator:

Jay L Alberts, PhD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.