Uncovering an Electrical Biomarker for Freezing of Gait in Parkinson's Disease

Completed · Not applicable

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to investigate brain signals related to freezing of gait (FoG), a symptom of Parkinson's Disease, that can lead to dangerous falls. The investigators hypothesize that uncovering these signals can lead to better deep brain stimulation interventions.

Key facts

Study ID

NCT02548897

Run by

University of Florida

People needed

5

Starts

2015-10-01

Expected to finish

2017-08-15

Last updated by the study team

2017-09-25

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of idiopathic PD, without a previous DBS operation and must be deemed appropriate for a DBS operation by the interdisciplinary screening team (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
• Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state).
• Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
• Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
• L-dopa responsive with clearly defined "on" periods.
• Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

You may not qualify if…

• Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
• Evidence of secondary or atypical parkinsonism.
• Other neurological and musculoskeletal impairments that would negatively influence postural stability
• Past MRI scan with significant evidence of brain atrophy or other abnormalities.
• Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
• A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
• Subjects with a history of seizures.
• Subjects who may require repeat MRI scans.
• Subjects with a history of a cranial neurosurgical procedure.
• Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
• Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
• Pregnant or nursing women or women who wish to become pregnant will be excluded.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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