Recruiting

DBS & Treadmill

Sponsor:

University of Florida

Code:

NCT06911229

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation (DBS)

Study Details

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

Study ID

NCT06911229

Start date

Oct 1, 2025

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: DBS ON

DBS will be turned on

no intervention: DBS OFF

DBS will be turned off

Interventions

Deep Brain Stimulation (DBS)

Patients will receive DBS in the clinically-optimized setting.

Primary outcome measure

  • Step length rate of adaptation [ Time Frame: 1 hour ]
  • Step length magnitude of adaptation [ Time Frame: 1 hour ]
  • Step length after-effects [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Julia Choi, Ph.D.

3522941720juliachoi@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

More Information

Sponsor

University of Florida

Last update posted

Jul 15, 2026

Last verified

Aug, 2025

Keywords

  • Freezing of gait
  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-15.