At present, no drug therapy has been proven to delay the progression of Parkinson's disease (PD). rTMS, as a non-invasive neuromodulation method, can regulate Slow-wave sleep (SWS). SWS is recognized closely related to neurodegeneration. However, there has been no clinical studies on if rTMS could delay the progression of PD by regulating SWS. The main purpose of this study is to explore the changes of SWS in non-rapid eye movement (NREM) sleep period in PD patients by using rTMS, and the relationship with potential improvements of SWS and motor symptom delay. The study aims to find a potential new treatment strategy to delay the neurodegenerative process in PD patients by modulating SWS by rTMS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
In the first stage, the early treatment group use low-frequency rTMS real stimulation,
In the first stage, the control group (delayed treatment group) all use sham stimulation.
In the second stage, both the early treatment group and the control group (delayed treatment group) will be treated with true stimulation low-frequency rTMS.
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGChange of Motor Function in PD by Low Frequency rTMS Stimulation
the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)\[off\] The higher the score, the more severe the motor dysfunction
Time frame: Day14
Effects of low-frequency rTMS stimulation on motor symptoms
the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII) \[on\] The higher the score, the more severe the motor dysfunction
Time frame: Day28,Day56
Measurement of improved balance function in patients with Parkinson's disease
the score of Berg Balance Scale (BBS)\[0-56\] The higher the score, the better the balance
Time frame: Day14,Day28,Day56
Assessment of sleep structure in patients with Parkinson's disease
Use polysomnography (PSG) to record the proportion of slow-wave sleep
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on anxiety
the score of Hamilton Anxiety Rating Scale（HAMA)\[0-64\] The higher the score, the more anxious
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on cognition
the score of Montreal Cognitive Assessment（Moca)\[0-30\] The lower the score, the more severe the cognitive dysfunction
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on cortical excitability
short-interval cortical inhibition(SICI)
Time frame: Day14,Day28
Effects of low-frequency rTMS stimulation on depression
the score of Hamilton Depression Rating Scale（HAMD） Total score ≥ 20 points: may be mild or moderate depression; The higher the score, the more depressed
Time frame: Day14,Day28,Day56
Assessment of daytime sleepiness in patients with Parkinson's disease
the score of The Epworth Sleeping Scale(ESS)\[0-24\] The higher the score, the more lethargic
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on gait
Use a quantitative gait analysis system to analyze the change of gait
Time frame: Day14,Day28,Day56
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