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

Last updated: May 10, 2025
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Parkinson's Disease

Dyskinesias

Treatment

rTMS real stimulation stage 2

rTMS shame stimulation stage1

rTMS real stimulation stage1

Clinical Study ID

NCT06002581
CCTR-2022B05
  • Ages 50-80
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Meet the clinically definite or clinically probable PD according to the MDS 2015version.

  2. Chinese Han population (three generations), age greater than or equal to 50 yearsold, 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 andduring the follow-up period.

  5. Right-handed.

  6. The patient signed a written informed consent.

Exclusion

Exclusion Criteria:

  1. Any form of Parkinsonism other than primary PD.

  2. Those who have received neurosurgical intervention or stereotaxic brain surgery forPD, or have previously received TMS treatment.

  3. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with thescale 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 sleepstructure.

  10. Those who are unwilling to participate in the study or unable to sign the informedconsent form; and other circumstances that the researcher considers inappropriate toparticipate in the study.

Study Design

Total Participants: 56
Treatment Group(s): 3
Primary Treatment: rTMS real stimulation stage 2
Phase:
Study Start date:
September 03, 2023
Estimated Completion Date:
July 28, 2026

Connect with a study center

  • Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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