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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
vary the frequency of the stimulation parameter
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGGeneral Hospital of PLA
Beijing, China
RECRUITINGPeking Union Medical College Hospital
Stand-Walk-Sit
The total time of patients who complete the Stand-Walk-Sit task
Time frame: at 3 months compare to baseline
United Parkinson's Disease Rate Scale scores
Time frame: at 3、6 months compare to baseline
The39-item Parkinson's Disease Questionnaire (PDQ-39) scores
Time frame: at 3、6 months compare to baseline
The Freezing of Gait Questionnaire (FOG-Q) scores
Time frame: at 3、6 months compare to baseline
Gait and Falls Questionnaire (GFQ) scores
Time frame: at 3、6 months compare to baseline
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Enrollment
106
Beijing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
RECRUITINGNanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing, China
RECRUITINGChanghai Hospital of Shanghai
Shanghai, China
RECRUITINGHuashan hospital, Fudan university
Shanghai, China
RECRUITINGThe General Hospital of Shenyang Military
Shenyang, China
RECRUITINGSecond People's Hospital of Shenzhen
Shenzhen, China
RECRUITING