How deep brain stimulation affects walking adaptation and freezing in Parkinson's
Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
This test will see if turning deep brain stimulation on helps people with Parkinson's adapt their walking and reduce freezing while walking on a split-belt treadmill off medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06911229 on ClinicalTrials.gov |
What this trial studies
Participants will walk on a split-belt treadmill through baseline (1:1), adaptation (2:1) and post-adaptation (1:1) phases to measure locomotor adaptation and freezing of gait. Each participant will perform the protocol twice: once with deep brain stimulation (DBS) turned on and once with DBS turned off, while off their Parkinson's medications. The study will record gait metrics, adaptation rate, and freezing episodes, and compare neurophysiological responses between DBS conditions. Eligible participants are adults with idiopathic Parkinson's disease who have had stable DBS for at least six months and can walk without aids.
Who should consider this trial
Good fit: Ideal candidates are adults (18–80) with idiopathic Parkinson's disease who have had chronically stable DBS for at least six months, have no dementia, and can walk unaided while able to attend in-person testing.
Not a fit: People without DBS, with recent or unstable DBS (<6 months), significant cognitive impairment, atypical parkinsonism, or who require walking aids are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, the results could guide DBS programming or rehabilitation strategies to improve walking adaptability and reduce freezing, potentially improving mobility and lowering fall risk.
How similar studies have performed: Previous small studies indicate DBS can influence gait and adaptation but findings are mixed, and using split-belt treadmill paradigms with DBS patients remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Julia Choi, Ph.D.
- Email: juliachoi@ufl.edu
- Phone: 3522941720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.