Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Xiaoying Zhu, doctor
docxiaoying@163.com
+86 21 63240090
Time Frame
Start Date: 2023-09-03
Estimated Completion Date: 2026-07-28
Participants
Target number of participants: 56
Treatments
Experimental: the early treatment group
stage1+stage2 real stimulation
Other: the control group (delayed treatment group)
stage1 sham stimulation + stage2 real stimulation
Related Therapeutic Areas
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov