This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would have significant clinical implications in the management of Freezing of gait (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).
HFS of STN provides consistent, long-term improvement of the cardinal motor signs of PD, such as bradykinesia, tremor and rigidity. FOG has responded poorly to HFS and tends to continue to deteriorate over time, but this can be alleviated by relatively LFS. Evidence has indicated that LFS-STN can improve axial signs in some but not all PD patients, but most of them experienced loss of efficacy in the short term. Then comes to the little improvement or even worse of tremor, rigidity and bradykinesia, which consists of the three main symptoms of Parkinson's disease. Thus even if axial problems could be solved by LFS in a long way, it could also be hard to tolerate by those patients. The effect of VFS on FOG will be studied. The investigators hypothesize that VFS could have better effect on Freezing of gait than HFS and LFS.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
Deep Brain Stimulation
Tsinghua University Yuquan Hospital
Beijing, Beijing Municipality, China
Beijing Tian Tan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Timed Up and Go (TUG) task
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Time frame: The outcome of TUG task at 12 months follow-up.
the number of freezing episodes for TUG task
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Time frame: The outcome of TUG task at 12 months follow-up.
UPDRS III scores
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Gait and Falls Questionnaire (GFQ) scores
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
the39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
the Freezing of Gait Questionnaire (FOG-Q) scores
Time frame: Outcome of VFS at 6 、12months with reference to baseline HFS
Number of adverse events (AE's)
Time frame: Change from Baseline to 6、12 Months
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