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

Conditions

• Freezing of Gait
• Parkinson Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.
• 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.

Study Details

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.

Key Dates

First listed

Aug 6, 2026

Start date

Sep 18, 2026

Status verified

Jul 2026

Primary completion

Mar 18, 2027

Completion

Apr 18, 2027

Study Design

Enrollment

5 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

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.

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

• MacKenzie Dunlap
  216-219-3949
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

Related Studies

• Abbott DBS Post-Market Study of Outcomes for Indications Over Time
  Recruiting · Abbott Medical Devices · Tampa, Florida
• PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
  Recruiting · Michael J. Fox Foundation for Parkinson's Research · Birmingham, Alabama
• Personalized Real-Time DBS and PD Mechanisms
  PHASE4 · Recruiting · David Escobar · Cleveland, Ohio
• A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
  PHASE2 · Recruiting · AskBio Inc · Phoenix, Arizona