NCT06002581Recruiting
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 11 Jul 2023
- Start date
- 3 Sept 2023
- Primary completion date
- 28 Jul 2026
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Parkinson disease
- NCT number
- NCT06002581
What you commit to
- Study type: Interventional
- Planned participants: 56
- From 3 Sept 2023 to the primary completion date, 28 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
- 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.
Other illness
- Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI\>=30.
Other
- Any form of Parkinsonism other than primary PD.
- 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.
- 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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Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.