Status:
RECRUITING
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Parkinson's Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
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Key Trial Info
Start Date :
September 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06002581
Start Date
September 3 2023
End Date
July 28 2026
Last Update
December 9 2025
Active Locations (1)
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1
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200040