Clinical trial NCT06002581: Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
Official title: Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
slow-wave sleep
rTMS
motor symptom
progression
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
2. 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.
3. Hoehn-Yahr stages 1-4.
4. The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
5. Right-handed.
6. The patient signed a written informed consent.

Exclusion Criteria:

1. Any form of Parkinsonism other than primary PD.
2. Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
3. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
4. Persons with mental disabilities.
5. Pregnant women.
6. There are contraindications for rTMS treatment.
7. There are contraindications for MRI examination.
8. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI\>=30.
9. 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.
10. 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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Primary outcomes:
measure: Change of Motor Function in PD by Low Frequency rTMS Stimulation
timeFrame: Day14
Secondary outcomes:
measure: Effects of low-frequency rTMS stimulation on motor symptoms
timeFrame: Day28,Day56
measure: Measurement of improved balance function in patients with Parkinson's disease
timeFrame: Day14,Day28,Day56
measure: Assessment of sleep structure in patients with Parkinson's disease
timeFrame: Day14,Day28,Day56
measure: Effects of low-frequency rTMS stimulation on anxiety
timeFrame: Day14,Day28,Day56
measure: Effects of low-frequency rTMS stimulation on cognition
timeFrame: Day14,Day28,Day56
measure: Effects of low-frequency rTMS stimulation on cortical excitability
timeFrame: Day14,Day28
measure: Effects of low-frequency rTMS stimulation on depression
timeFrame: Day14,Day28,Day56
measure: Assessment of daytime sleepiness in patients with Parkinson's disease
timeFrame: Day14,Day28,Day56
measure: Effects of low-frequency rTMS stimulation on gait
timeFrame: Day14,Day28,Day56
Other outcomes:
measure: Effects of low-frequency rTMS stimulation on brain connectivity in the PD brain
timeFrame: Day0,Day14,Day28
measure: Changes in salivary melatonin levels
timeFrame: Day0,Day14,Day28,Day56
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaoying Zhu, doctor
role: PRINCIPAL_INVESTIGATOR
References: