Parkinson Disease Clinical Trial
Official title:
Selectively Modulating Pathophysiological Biomaker to Improve Freezing of Gait in Parkinson' s Disease by Adaptive Subthalamic Stimulation
Freezing of gait (FoG) is defined as a brief, episodic absence or reduction of forward
progression of the feet despite the intention to walk. It is one of the most disabling and
intractable motor symptoms in patients with Parkinson's disease (PD) as it often causes falls
and loss of independence. The pathophysiology of FoG remains unclear but it seems differ from
other cardinal motor symptoms in PD. The therapeutic efficacy of medical and surgical
treatments for FoG are usually suboptimal. Deep brain stimulation (DBS) in the subthalamic
nucleus (STN) is a well established treatment for advanced PD with motor fluctuation. It
alleviates tremor, bradykinesia and rigidity and improved the quality of life. However, the
therapeutic effects of DBS are impeded by high cost of device, stimulation induced adverse
effects and partial treatment for some parkinsonism symptoms, particular gait disturbance and
FoG. Recently, a new mode of stimulation is proposed. Differing from the conventional DBS
which is operated in open loop so that stimulation remains fixed over time and is delivered
at regular and high frequencies, the new adaptive DBS (aDBS) detects the pathological
activities and only deliver stimulation when it is necessary. Recent studies in MPTP-primate
and patients with PD demonstrate that the aDBS is superior to standard continuous DBS.
However, the therapeutic efficacy is only shown in "appendicular symptoms" such as
bradykinesia, rigidity and tremor. There is no report about the effect of aDBS on gait
disturbance, particular FoG in PD so far.
The aim of the current project is to test whether the therapeutic efficacy of aDBS is
superior to conventional DBS in PD patients with FoG. To this end, 20 advanced PD patients
who undergo STN DBS implantation for the treatment of their disorders will be examined. The
gait of patients will be assessed during conventional open loop stimulation and aDBS and the
therapeutic efficacy for FoG will be defined. The results of this study will also contribute
to better understanding of pathophysiology of FoG and to future development of embedded aDBS
system for PD.
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