NCT06002581

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	rTMS real stimulation stage1	In the first stage, the early treatment group use low-frequency rTMS real stimulation,
DEVICE	rTMS shame stimulation stage1	In the first stage, the control group (delayed treatment group) all use sham stimulation.
DEVICE	rTMS real stimulation stage 2	In the second stage, both the early treatment group and the control group (delayed treatment group) will be treated with true stimulation low-frequency rTMS.

Timeline

• Start date: 2023-09-03
• Primary completion: 2026-07-28
• Completion: 2026-07-28
• First posted: 2023-08-21
• Last updated: 2025-12-09

Locations

1 site across 1 country: China