Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Brain Stimulation (DBS).
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Deep Brain Stimulation (DBS)
Patients will receive DBS in the clinically-optimized setting.
Primary outcome measures
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT06911229 · IRB202401786 · R21AG088600