Parkinson's Disease
Conditions
Keywords
DBS, VFS, FOG
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.
Interventions
DEVICEDeep Brain Stimulation
Deep Brain Stimulation
Sponsors
Beijing Pins Medical Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients were receiving bilateral STN stimulation for more than six months. 2. They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait. 3. Subjects had an ability to walk at least 10 meters independently during ON DBS condition.
Exclusion criteria
1. gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease. 2. any change in the HFS DBS settings, three months prior to participation in the study. 3. complete inability to walk despite assistance while DBS ON. 4. Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing). 5. Subjects could not tolerate prolonged OFF medication condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| the39-item Parkinson's Disease Questionnaire (PDQ-39) scores | Outcome of VFS at 6、12 months with reference to baseline HFS |
| UPDRS III scores | Outcome of VFS at 6、12 months with reference to baseline HFS |
| 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 |
| Gait and Falls Questionnaire (GFQ) scores | Outcome of VFS at 6、12 months with reference to baseline HFS |
Countries
China
Outcome results
None listed