Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VFS | Experimental | variable frequency deep brain stimulation (VFS) |
|
| HFS | Active Comparator | high frequency deep brain stimulation (HFS) |
|
| LFS | Active Comparator | low frequency deep brain stimulation (LFS) |
|
| DBS off | No Intervention | deep brain stimulation off |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Deep Brain Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) task | variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS) | 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) | The outcome of TUG task at 12 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luming Li, Ph.D | Tsinghua University | Study Chair |
| Michael Okun, MD. | University of Florida | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsinghua University Yuquan Hospital | Beijing | Beijing Municipality | 100040 | China | ||
| Beijing Tian Tan Hospital,Capital Medical University |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| the39-item Parkinson's Disease Questionnaire (PDQ-39) scores |
| Outcome of VFS at 6、12 months with reference to baseline HFS |
| the Freezing of Gait Questionnaire (FOG-Q) scores | Outcome of VFS at 6 、12months with reference to baseline HFS |
| Number of adverse events (AE's) | Change from Baseline to 6、12 Months |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |