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

RECRUITINGNA

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

NCT06002581•Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 3, 2023

Primary Completion Date

July 28, 2026

Completion Date

July 28, 2026

Last Updated

December 9, 2025

Enrollment

ESTIMATED participants

Conditions

Parkinson's Disease

Interventions

rTMS real stimulation stage1

DEVICE

rTMS shame stimulation stage1

DEVICE

rTMS real stimulation stage 2

DEVICE

Contacts

Xiaoying Zhu, doctor

CONTACT

+86 21 63240090 docxiaoying@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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