Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Device: Deep Brain Stimulation
- Registration Number
- NCT02601144
- Lead Sponsor
- Beijing Pins Medical Co., Ltd
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Patients were receiving bilateral STN stimulation for more than six months.
- They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait.
- Subjects had an ability to walk at least 10 meters independently during ON DBS condition.
Exclusion criteria:
- gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease.
- any change in the HFS DBS settings, three months prior to participation in the study.
- complete inability to walk despite assistance while DBS ON.
- Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing).
- Subjects could not tolerate prolonged OFF medication condition.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LFS Deep Brain Stimulation low frequency deep brain stimulation (LFS) VFS Deep Brain Stimulation variable frequency deep brain stimulation (VFS) HFS Deep Brain Stimulation high frequency deep brain stimulation (HFS)
- Primary Outcome Measures
Name Time Method Timed Up and Go (TUG) task 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)
the number of freezing episodes for TUG task 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)
- Secondary Outcome Measures
Name Time Method Number of adverse events (AE's) Change from Baseline to 6、12 Months the Freezing of Gait Questionnaire (FOG-Q) scores Outcome of VFS at 6 、12months with reference to baseline HFS UPDRS III scores Outcome of VFS at 6、12 months with reference to baseline HFS Gait and Falls Questionnaire (GFQ) scores Outcome of VFS at 6、12 months with reference to baseline HFS the39-item Parkinson's Disease Questionnaire (PDQ-39) scores Outcome of VFS at 6、12 months with reference to baseline HFS
Trial Locations
- Locations (2)
Tsinghua University Yuquan Hospital
🇨🇳Beijing, Beijing, China
Beijing Tian Tan Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China