Deep brain stimulation
DeviceDeep Brain Stimulation
NCT Number: NCT02601144
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing Tian Tan Hospital,Capital Medical University, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Deep Brain Stimulation
Time frame: The outcome of TUG task at 12 months follow-up.
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.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Time frame: Outcome of VFS at 6、12 months with reference to baseline HFS
Time frame: Outcome of VFS at 6 、12months with reference to baseline HFS
Time frame: Change from Baseline to 6、12 Months
Beijing Pins Medical Co., Ltd
Industry
Double-Blind Trial of Variable Frequency Stimulation for Freezing of Gait in Parkinson's Disease
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