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

University of Florida

Status: Begins enrollment in 1 month

Conditions: Parkinson Disease

Treatments: Device: Deep Brain Stimulation (DBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06911229

IRB202401786

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DBS ON

Active Comparator group

Description:

DBS will be turned on

Treatment:

Device: Deep Brain Stimulation (DBS)

DBS OFF

No Intervention group

Description:

DBS will be turned off