Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2023-09-03
Last updated
2025-12-09
Condition(s) studied
Parkinson's Disease
Investigational drug(s) / intervention(s)
rTMS real stimulation stage1rTMS shame stimulation stage1rTMS real stimulation stage 2
rTMS real stimulation stage1: In the first stage, the early treatment group use low-frequency rTMS real stimulation,
rTMS shame stimulation stage1: In the first stage, the control group (delayed treatment group) all use sham stimulation.
rTMS real stimulation stage 2: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
2. Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female.
3. Hoehn-Yahr stages 1-4.
4. The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
5. Right-handed.
6. The patient signed a written informed consent.
Exclusion Criteria:
1. Any form of Parkinsonism other than primary PD.
2. Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
3. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
4. Persons with mental disabilities.
5. Pregnant women.
6. There are contraindications for rTMS treatment.
7. There are contraindications for MRI examination.
8. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI\>=30.
9. Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure.
10. Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study.
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Primary outcome measure(s)
Change of Motor Function in PD by Low Frequency rTMS Stimulation — Day14 the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)\[off\] The higher the score, the more severe the motor dysfunction
Trial sites (1)
Facility
City
Region
Status
Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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