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
1 other identifier
interventional
56
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
September 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 28, 2026
December 9, 2025
December 1, 2025
2.9 years
July 11, 2023
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Motor Function in PD by Low Frequency rTMS Stimulation
the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)\[off\] The higher the score, the more severe the motor dysfunction
Day14
Secondary Outcomes (9)
Effects of low-frequency rTMS stimulation on motor symptoms
Day28,Day56
Measurement of improved balance function in patients with Parkinson's disease
Day14,Day28,Day56
Assessment of sleep structure in patients with Parkinson's disease
Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on anxiety
Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on cognition
Day14,Day28,Day56
- +4 more secondary outcomes
Other Outcomes (2)
Effects of low-frequency rTMS stimulation on brain connectivity in the PD brain
Day0,Day14,Day28
Changes in salivary melatonin levels
Day0,Day14,Day28,Day56
Study Arms (2)
the early treatment group
EXPERIMENTALstage1+stage2 real stimulation
the control group (delayed treatment group)
OTHERstage1 sham stimulation + stage2 real stimulation
Interventions
In the first stage, the early treatment group use low-frequency rTMS real stimulation,
In the first stage, the control group (delayed treatment group) all use sham stimulation.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoying Zhu, doctor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate chief physician of neurology
Study Record Dates
First Submitted
July 11, 2023
First Posted
August 21, 2023
Study Start
September 3, 2023
Primary Completion (Estimated)
July 28, 2026
Study Completion (Estimated)
July 28, 2026
Last Updated
December 9, 2025
Record last verified: 2025-12