The purpose of this trial is to study the safety, practicality, and effectiveness of deep brain stimulation (DBS) therapy in a brain region called the cuneiform nucleus (CnF) to treat disabling freezing of gait (FOG) in patients with Parkinson's disease (PD) when standard treatments are no longer effective. The study uses either the Medtronic's Percept™ PC or RC systems for DBS therapy. Please note that although the Medtronic systems are FDA-approved for other diseases, they have not been approved for the treatment of FOG in PD and their use for stimulation of the CnF target is experimental.
This is a multi-site, prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial assessing the extent to which cuneiform nucleus deep brain stimulation (CnF DBS) can ameliorate freezing of gait (FOG) in Parkinson's Disease (PD) patients with severe, Levodopa-resistant gait freezing. The study intends to determine the optimal stimulation parameters (frequency, pulse, amplitude) that maximize gait performance while minimizing any potential side effects and to evaluate the effect of CnF DBS on other PD symptoms (including pain) and quality of life. Participation in the study is expected to last approximately eight months from enrollment through completion of study activities. Study procedures include medical and neurological evaluations, walking and mobility assessments, questionnaires, brain imaging, device programming visits, and collection of information about your symptoms, safety, and quality of life. The most significant risks of participation are those associated with DBS surgery and chronic brain stimulation, including bleeding, infection, stroke, seizure, device-related complications, worsening of neurological symptoms, falls, and stimulation-related side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Active CnF DBS will be delivered using predefined stimulation parameter ranges considered potentially therapeutic based on prior preclinical and clinical data.
Control (sham or sub-therapeutic) stimulation will consist of stimulation settings expected to have no or minimal physiological effect (e.g., stimulation off or amplitude below a predefined threshold).
University of California San Francisco (UCSF)
San Francisco, California, United States
University of Miami
Miami, Florida, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Timed Up and Go (TUG) Time
Change in Timed Up and Go (TUG) time with and without bilateral CnF DBS
Time frame: Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit
Pirouette Test Times
Change in right and left pirouette test times with and without bilateral CnF DBS
Time frame: Baseline Visit; Randomization Visit (14 Days Following DBS Implantation); 1, 2, 3, 4, 5, and 6-Month Post-Randomization Follow-Up Visit
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