Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS real stimulation stage1, rTMS shame stimulation stage1, rTMS real stimulation stage 2.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change of Motor Function in PD by Low Frequency rTMS Stimulation [Time frame: Day14]
Secondary outcome measures (9)
- Effects of low-frequency rTMS stimulation on motor symptoms [Time frame: Day28,Day56]
- Measurement of improved balance function in patients with Parkinson's disease [Time frame: Day14,Day28,Day56]
- Assessment of sleep structure in patients with Parkinson's disease [Time frame: Day14,Day28,Day56]
- Effects of low-frequency rTMS stimulation on anxiety [Time frame: Day14,Day28,Day56]
- Effects of low-frequency rTMS stimulation on cognition [Time frame: Day14,Day28,Day56]
- Effects of low-frequency rTMS stimulation on cortical excitability [Time frame: Day14,Day28]
- Effects of low-frequency rTMS stimulation on depression [Time frame: Day14,Day28,Day56]
- Assessment of daytime sleepiness in patients with Parkinson's disease [Time frame: Day14,Day28,Day56]
- Effects of low-frequency rTMS stimulation on gait [Time frame: Day14,Day28,Day56]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06002581 · CCTR-2022B05