Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT06002581

Run by

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

People needed

56

Starts

2023-09-03

Expected to finish

2026-07-28

Last updated by the study team

2025-12-09

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
• 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.
• Hoehn-Yahr stages 1-4.
• The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
• Right-handed.
• The patient signed a written informed consent.

You may not qualify if…

• Any form of Parkinsonism other than primary PD.
• Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
• Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
• Persons with mental disabilities.
• Pregnant women.
• There are contraindications for rTMS treatment.
• There are contraindications for MRI examination.
• Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI>=30.
• 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.
• 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.

Where it is running

• Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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