Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease

NCT06911229 | Recruiting

• 2 other identifiers: IRB202401786R21AG088600
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.

Conditions

Parkinson Disease

Keywords

Freezing of gait; deep brain stimulation

Outcome Measures

Primary Outcomes (3)

• Step length rate of adaptation

  The rate of adaptation in step length asymmetry is estimated by fitting an exponential decay function to step length asymmetry over the first 100 strides in adaptation.

  1 hour

• Step length magnitude of adaptation

  The magnitude of adaptation in step length asymmetry is calculated as the mean difference in step length asymmetry between early and late adaptation.

  1 hour

• Step length after-effects

  The after-effect in step length asymmetry is calculated as the mean difference in step length asymmetry between baseline and early post-adaptation.

  1 hour

Study Arms (2)

DBS ON

ACTIVE COMPARATOR

DBS will be turned on

Device: Deep Brain Stimulation (DBS)

DBS OFF

NO INTERVENTION

DBS will be turned off

Interventions

Deep Brain Stimulation (DBS) DEVICE

Patients will receive DBS in the clinically-optimized setting.

DBS ON

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
• chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
• Age between 18 - 80 years old per the FDA data sheet for PD DBS;
• no dementia according to the clinical diagnostic criteria for PD dementia;
• ambulatory without the use of walking aids, or another person's assistance.

You may not qualify if:

• other previous neurological surgery;
• suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Julia Choi, Ph.D.

CONTACT

3522941720; juliachoi@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 15, 2026

Record last verified: 2025-08

Locations

US (1)