About this trial
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥40 years old
Meet Movement Disorder Society standards;
Have no history of drug adjustment within 4 weeks before and during treatment;
The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
Disqualifiers
Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
Trial design
Parallel
Treatments tested in this trial
transcranial magnetic stimulation
DeviceThe stimulations were performed by MagStim Rapid2.
Treatment groups
Trial outcomes
Primary outcomes
Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores
This is an very common clinical motor estimating scale with 18 items and 140' in total. Higher scores indicate worse symptoms.
Secondary outcomes
Movement Disorder Society- Unified Parkinson's Disease Rating Scale I scores
MDS-UPDRS Ⅰ was used to evaluate the experience of non-motor symptoms of daily living in patients with Parkinson's disease. Items 1.1 to 1.6 were asked and evaluated by the raters, including some cognitive impairment, anxiety and depression symptoms, and dopamine dysregulation symptoms. Items 1.7-1.13 were scored by the patients themselves, and the problems involved included sleep, fatigue, urination, constipation, etc.
Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores
MDS-UPDRS II is used to evaluate the patient's experience of motor symptoms of daily living, such as speech function, eating capacity, daily living capacity (eating, dressing, hygiene), tremor, walking, etc.
Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores
The MDS-UPDRS Ⅳ questionnaire consisted of raters combining previously known and objective information on patients with two motor complications: motor fluctuations and AIMs. All three segments are rated on a 0-4 scale.
Hoehn-Yahr(H-Y) scale
H-Y scale is a standardized instrument used to evaluate the severity of Parkinson's disease. It employs a scoring system that ranges from 1 to 5, with higher scores indicating greater severity of clinical symptoms and a corresponding decline in quality of life. The assessment criteria primarily consider the number of limbs affected, the presence of balance disturbances, and the extent of functional impairment in daily living activities. This scale is valued for its simplicity and practicality, making it a prevalent tool in clinical trials for evaluating Parkinson's disease symptoms.
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