Parkinsons Disease Clinical Trial
Official title:
A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these two brain regions after surgery will allow for the development of a personalized DBS system to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the optimized device settings.
As a participant in the study you will have the following procedure performed:
A series of questions by interview, questionnaires, and checklists will be collected. In
addition, basic information (such as age, sex, race) and psychiatric, medical, and family
history, physical and neurological exam that will include measuring vital signs (heart rate
and blood pressure). There will be a "Falls Diary' to complete (an account of falling
incidents and the details). Specific testing will be done to evaluate the gait and balance
which will be repeated throughout the study. A psychiatric evaluation of mood and emotion
will be performed including a detailed psychological testing, consisting of perception,
learning, and memory. These psychological assessments will be repeated at every study visit.
An MRI and a CT scan will be performed to make sure of the exact location of the DBS implant.
The study will end in 24 months.
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