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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06911229
• Lead Sponsor: University of Florida

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.

Detailed Description

We will test the hypotheses that DBS can facilitate split-belt walking adaptation with DBS ON compared with DBS OFF.

Study Timeline

• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Start: 2025-07-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Step length rate of adaptation	1 hour	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.
Step length after-effects	1 hour	The after-effect in step length asymmetry is calculated as the mean difference in step length asymmetry between the last 5 strides of baseline and the first 5 series of post-adaptation.
Step length magnitude of adaptation	1 hour	The magnitude 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.