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In the VFS paradigm the stimulation frequency was set to alternate between high and low frequencies, where the frequency of stimulation or frequency combinations can be changed instantaneously according to damage of the moment rhythms. Variable frequency stimulation is a novel dynamic therapy which breaks through the existing single high-frequency stimulation paradigms. It is the world's first VFS therapy for the brain.
In advanced stages of PD, motor symptoms and dyskinesia are effectively treated by deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) . Traditionally, in this procedure, stimulation is set to a constant frequency electrical stimulation with the physician programming the parameters of stimulation frequency, pulse width and amplitude, and stimulated patients' brain nuclei with single frequency, single pulse width and single amplitude of the electric stimulation. Indeed, high frequency stimulation (HFS) of the STN provides consistent, long-term improvement of the cardinal signs of PD . However, the treatment effects of HFS on the axial symptoms of PD, specifically FOG can be poor often causing further impairment. While this can be alleviated by using relatively low frequency stimulation (LFS) , major concerns in the clinical application of LFS exist in regards to its duration of therapeutic benefit. Previous studies have shown that LFS of the STN improves the axial motor signs in some PD patients, but a loss of therapeutic efficacy is seen in the short term. Thereafter, patients may present increased tremor, rigidity and bradykinesia, which is often intolerable outweighing the initial benefits of LFS therapy for FOG. As such, a suitable treatment strategy for FOG remains to be established.
Based on previous findings on the relationships between stimulation frequency and movement rhythm regulation in the human body, The National Engineering Laboratory for Neuromodulation, Tsinghua University, proposes a method of variable frequency stimulation (VFS) for aiding movement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Variable Frequency Stimulation | Experimental | Subjects in this group received variable frequency stimulation of deep brain stimulation |
|
| Constant Frequency Stimulation | Sham Comparator | Subjects in this group received constant frequency stimulation of deep brain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variable Frequency Stimulation | Procedure | vary the frequency of the stimulation parameter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stand-Walk-Sit | The total time of patients who complete the Stand-Walk-Sit task | at 3 months compare to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| United Parkinson's Disease Rate Scale scores | at 3、6 months compare to baseline | |
| The39-item Parkinson's Disease Questionnaire (PDQ-39) scores | at 3、6 months compare to baseline | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fumin Jia | Contact | 010-60736388 | pins_medical@163.com | |
| Luming Li | Contact | 010-60736388 |
| Name | Affiliation | Role |
|---|---|---|
| Luming Li | Tsinghua University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31856908 | Derived | Jia F, Zhang J, Wang H, Liang Z, Liu W, Wang X, Liu Y, Guo Y, Ling Z, Cai X, Wu X, Wu J, Lv W, Xu X, Zhang W, Li L. Variable- versus constant-frequency deep-brain stimulation in patients with advanced Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2019 Dec 19;20(1):749. doi: 10.1186/s13063-019-3884-4. |
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Patients and the outcomes assessor are blinded in this study
| The Freezing of Gait Questionnaire (FOG-Q) scores |
| at 3、6 months compare to baseline |
| Gait and Falls Questionnaire (GFQ) scores | at 3、6 months compare to baseline |
| General Hospital of PLA | Recruiting | Beijing | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | China |
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| Nanjing Brain Hospital Affiliated to Nanjing Medical University | Recruiting | Nanjing | China |
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| Changhai Hospital of Shanghai | Recruiting | Shanghai | China |
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| Huashan hospital, Fudan university | Recruiting | Shanghai | China |
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| The General Hospital of Shenyang Military | Recruiting | Shenyang | China |
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| Second People's Hospital of Shenzhen | Recruiting | Shenzhen | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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