Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200040, China
Location status: Recruiting
NCT Number: NCT06002581
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200040, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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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.
Time frame: Day14
the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)[off] The higher the score, the more severe the motor dysfunction
Time frame: Day28,Day56
the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII) [on] The higher the score, the more severe the motor dysfunction
Time frame: Day14,Day28,Day56
the score of Berg Balance Scale (BBS)[0-56] The higher the score, the better the balance
Time frame: Day14,Day28,Day56
Use polysomnography (PSG) to record the proportion of slow-wave sleep
Time frame: Day14,Day28,Day56
the score of Hamilton Anxiety Rating Scale(HAMA)[0-64] The higher the score, the more anxious
Time frame: Day14,Day28,Day56
the score of Montreal Cognitive Assessment(Moca)[0-30] The lower the score, the more severe the cognitive dysfunction
Time frame: Day14,Day28
short-interval cortical inhibition(SICI)
Time frame: Day14,Day28,Day56
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
the score of The Epworth Sleeping Scale(ESS)[0-24] The higher the score, the more lethargic
Time frame: Day14,Day28,Day56
Use a quantitative gait analysis system to analyze the change of gait
Time frame: Day0,Day14,Day28
functional magnetic resonance imaging (fMRI) (Default mode network, DMN)
Time frame: Day0,Day14,Day28,Day56
salivary melatonin levels(Fasting)
Contact information is provided by the study sponsor or research team.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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